[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR341]
[Page 235-252]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--Continued
PART 341--COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart A--General Provisions
Sec.
341.1 Scope.
341.3 Definitions.
Subpart B--Active Ingredients
341.12 Antihistamine active ingredients.
341.14 Antitussive active ingredients.
341.16 Bronchodilator active ingredients.
341.18 Expectorant active ingredient.
341.20 Nasal decongestant active ingredients.
Subpart C--Labeling
341.70 Labeling of OTC drug products containing ingredients that are
used for treating concurrent symptoms (in either a single-
ingredient or combination drug product).
341.72 Labeling of antihistamine drug products.
341.74 Labeling of antitussive drug products.
341.76 Labeling of bronchodilator drug products.
[[Page 236]]
341.78 Labeling of expectorant drug products.
341.80 Labeling of nasal decongestant drug products.
341.90 Professional labeling.
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Subpart A--General Provisions
Sec. 341.1 Scope.
(a) An over-the-counter cold, cough, allergy, bronchodilator, or
antiasthmatic drug product in a form suitable for oral, inhalant, or
topical administration is generally recognized as safe and effective and
is not misbranded if it meets each of the conditions in this part and
each of the general conditions established in Sec. 330.1.
(b) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21 unless otherwise noted.
[51 FR 35339, Oct. 2, 1986]
Sec. 341.3 Definitions.
As used in this part:
(a) Bronchodilator drug. A drug used to overcome spasms that cause
narrowing of the bronchial air tubes, such as in the symptomatic
treatment of the wheezing and shortness of breath of asthma.
(b) Oral antitussive drug. A drug that either is taken by mouth or
is dissolved in the mouth in the form of a lozenge and acts systemically
to relieve cough.
(c) Topical antitussive drug. A drug that relieves cough when
inhaled after being applied topically to the throat or chest in the form
of an ointment or from a steam vaporizer, or when dissolved in the mouth
in the form of a lozenge for a local effect.
(d) Expectorant drug. A drug taken orally to promote or facilitate
the removal of secretions from the respiratory airways.
(e) Antihistamine drug. A drug used for the relief of the symptoms
of hay fever and upper respiratory allergies (allergic rhinitis).
(f) Oral nasal decongestant drug. A drug that is taken by mouth and
acts systemically to reduce nasal congestion caused by acute or chronic
rhinitis.
(g) Topical nasal decongestant drug. A drug that when applied
topically inside the nose, in the form of drops, jellies, or sprays, or
when inhaled intranasally reduces nasal congestion caused by acute or
chronic rhinitis.
(h) Calibrated dropper. A dropper calibrated such that the volume
error incurred in measuring any liquid does not exceed 15 percent under
normal use conditions.
[51 FR 35339, Oct. 2, 1986, as amended at 54 FR 8509, Feb. 28, 1989; 55
FR 40382, Oct. 3, 1990; 57 FR 58374, Dec. 9, 1992; 59 FR 43409, Aug. 23,
1994]
Subpart B--Active Ingredients
Sec. 341.12 Antihistamine active ingredients.
The active ingredient of the product consists of any of the
following when used within the dosage limits established for each
ingredient:
(a) Brompheniramine maleate.
(b) Chlorcyclizine hydrochloride.
(c) Chlorpheniramine maleate.
(d) Dexbrompheniramine maleate.
(e) Dexchlorpheniramine maleate.
(f) Diphenhydramine citrate.
(g) Diphenhydramine hydrochloride.
(h) Doxylamine succinate.
(i) Phenindamine tartrate.
(j) Pheniramine maleate.
(k) Pyrilamine maleate.
(l) Thonzylamine hydrochloride.
(m) Triprolidine hydrochloride.
[57 FR 58374, Dec. 9, 1992, as amended at 59 FR 4218, Jan. 28, 1994]
Sec. 341.14 Antitussive active ingredients.
The active ingredients of the product consist of any of the
following when used within the dosage limits and in the dosage forms
established for each ingredient in Sec. 341.74(d):
(a) Oral antitussives. (1) Chlophedianol hydrochloride.
(2) Codeine ingredients. The following ingredients may be used only
in combination in accordance with Secs. 329.20(a) and 341.40 and 21 CFR
1308.15(c).
(i) Codeine.
(ii) Codeine phosphate.
(iii) Codeine sulfate.
(3) Dextromethorphan.
(4) Dextromethorphan hydrobromide.
(5) Diphenhydramine citrate.
(6) Diphenhydramine hydrochloride.
[[Page 237]]
(b) Topical antitussives.
(1) Camphor.
(2) Menthol.
[52 FR 30055, Aug. 12, 1987, as amended at 59 FR 29174, June 3, 1994]
Sec. 341.16 Bronchodilator active ingredients.
The active ingredients of the product consist of any of the
following when used within the dosage limits established for each
ingredient:
(a) Ephedrine.
(b) Ephedrine hydrochloride.
(c) Ephedrine sulfate.
(d) Epinephrine.
(e) Epinephrine bitartrate.
(f) Racephedrine hydrochloride.
(g) Racepinephrine hydrochloride.
[51 FR 35339, Oct. 2, 1986]
Sec. 341.18 Expectorant active ingredient.
The active ingredient of the product is guaifenesin when used within
the dosage limits established in Sec. 341.78(d).
[54 FR 8509, Feb. 28, 1989]
Sec. 341.20 Nasal decongestant active ingredients.
The active ingredient of the product consists of any of the
following when used within the dosage limits and in the dosage forms
established for each ingredient:
(a) Oral nasal decongestants. (1) Phenylephrine hydrochloride.
(2) Pseudoephedrine hydrochloride.
(3) Pseudoephedrine sulfate.
(b) Topical nasal decongestants. (1) Levmetamfetamine.
(2) Ephedrine.
(3) Ephedrine hydrochloride.
(4) Ephedrine sulfate.
(5) [Reserved]
(6) Naphazoline hydrochloride.
(7) Oxymetazoline hydrochloride.
(8) Phenylephrine hydrochloride.
(9) Propylhexedrine.
(10) Xylometazoline hydrochloride.
[59 FR 43409, Aug. 23, 1994, as amended at 63 FR 40650, July 30, 1998]
Subpart C--Labeling
Sec. 341.70 Labeling of OTC drug products containing ingredients that
are used for treating concurrent symptoms (in either a single-
ingredient or combination drug product).
The statements of identity, indications, warnings, and directions
for use, respectively, applicable to each ingredient in the product may
be combined to eliminate duplicative words or phrases so that the
resulting information is clear and understandable.
(a) For products containing diphenhydramine citrate and
diphenhydramine hydrochloride identified in Sec. 341.14(a)(5) and
(a)(6). The labeling of the product contains the established name of the
drug, if any, and identifies the product as an ``antihistamine/cough
suppressant'' or ``antihistamine/antitussive (cough suppressant).'' The
indications shall be combined from Secs. 341.72(b) and 341.74(b). The
warnings shall be combined from Secs. 341.72(c)(1), (c)(2), (c)(4), and
(c)(6) and 341.74(c)(1), (c)(2), (c)(3), and (c)(4). Alternatively, all
of the warnings in Sec. 341.74(c) shall be used. The directions for OTC
labeling shall follow Secs. 341.74(d)(1)(iv) or (d)(1)(v), as
applicable. The directions for professional labeling shall follow
Sec. 341.90(j) or (k), as applicable.
(b) (Reserved)
[61 FR 15703, Apr. 9, 1996]
Sec. 341.72 Labeling of antihistamine drug products.
(a) Statement of identity. The labeling of the product contains the
established name of the drug, if any, and identifies the product as an
``antihistamine.''
(b) Indications. The labeling of the product states, under the
heading ``Indications,'' any of the phrases listed in paragraph (b) of
this section, as appropriate. Other truthful and nonmisleading
statements, describing only the indications for use that have been
established and listed in this paragraph, may also be used, as provided
in Sec. 330.1(c)(2) of this chapter, subject to the provisions of
section 502 of the Federal Food, Drug, and Cosmetic Act (the act)
relating to misbranding and the
[[Page 238]]
prohibition in section 301(d) of the act against the introduction or
delivery for introduction into interstate commerce of unapproved new
drugs in violation of section 505(a) of the act.
(1) ``Temporarily'' (select one of the following: ``relieves,''
``alleviates,'' ``decreases,'' ``reduces,'' or ``dries'') ``runny nose
and'' (select one of the following: ``relieves,'' ``alleviates,''
``decreases,'' or ``reduces'') ``sneezing, itching of the nose or
throat, and itchy, watery eyes due to hay fever'' (which may be followed
by one or both of the following: ``or other upper respiratory
allergies'' or ``(allergic rhinitis)'').
(2) ``For the temporary relief of runny nose, sneezing, itching of
the nose or throat, and itchy, watery eyes due to hay fever'' (which may
be followed by one or both of the following: ``or other upper
respiratory allergies'' or ``(allergic rhinitis)'').
(c) Warnings. The labeling of the product contains the following
warnings, under the heading ``Warnings'':
(1) ``May cause excitability especially in children.''
(2) ``Do not take this product, unless directed by a doctor, if you
have a breathing problem such as emphysema or chronic bronchitis, or if
you have glaucoma or difficulty in urination due to enlargement of the
prostate gland.''
(3) For products containing brompheniramine maleate, chlorcyclizine
hydrochloride, chlorpheniramine maleate, dexbrompheniramine maleate,
dexchlorpheniramine maleate, phenindamine tartrate, pheniramine maleate,
pyrilamine maleate, thonzylamine hydrochloride, or triprolidine
hydrochloride identified in Sec. 341.12(a), (b), (c), (d), (e), (i),
(j), (k), (l), and (m). ``May cause drowsiness; alcohol, sedatives, and
tranquilizers may increase the drowsiness effect. Avoid alcoholic
beverages while taking this product. Do not take this product if you are
taking sedatives or tranquilizers, without first consulting your doctor.
Use caution when driving a motor vehicle or operating machinery.''
(4) For products containing diphenhydramine citrate, diphenhydramine
hydrochloride, or doxylamine succinate identified in Sec. 341.12(f),
(g), and (h). ``May cause marked drowsiness; alcohol, sedatives, and
tranquilizers may increase the drowsiness effect. Avoid alcoholic
beverages while taking this product. Do not take this product if you are
taking sedatives or tranquilizers, without first consulting your doctor.
Use caution when driving a motor vehicle or operating machinery.''
(5) For products containing phenindamine tartrate identified in
Sec. 341.12(i). ``May cause nervousness and insomnia in some
individuals.''
(6) For products that are labeled only for use by children under 12
years of age. The labeling of the product contains only the warnings
identified in paragraphs (c)(1) and (c)(5) of this section as well as
the following:
(i) ``Do not give this product to children who have a breathing
problem such as chronic bronchitis, or who have glaucoma, without first
consulting the child's doctor.''
(ii) For products containing brompheniramine maleate,
chlorpheniramine maleate, dexbrompheniramine maleate,
dexchlorpheniramine maleate, phenindamine tartrate, pheniramine maleate,
pyrilamine maleate, thonzylamine hydrochloride, or triprolidine
hydrochloride identified in Sec. 341.12(a), (c), (d), (e), (i), (j),
(k), (l), and (m). ``May cause drowsiness. Sedatives and tranquilizers
may increase the drowsiness effect. Do not give this product to children
who are taking sedatives or tranquilizers, without first consulting the
child's doctor.''
(iii) For products containing diphenhydramine citrate,
diphenhydramine hydrochloride, or doxylamine succinate identified in
Sec. 341.12(f), (g), and (h). ``May cause marked drowsiness. Sedatives
and tranquilizers may increase the drowsiness effect. Do not give this
product to children who are taking sedatives or tranquilizers, without
first consulting the child's doctor.''
(d) Directions. The labeling of the product contains the following
information under the heading ``Directions'':
(1) For products containing brompheniramine maleate identified in
Sec. 341.12(a). Adults and children 12 years of age and over: oral
dosage is 4 milligrams every 4 to 6 hours, not to exceed
[[Page 239]]
24 milligrams in 24 hours, or as directed by a doctor. Children 6 to
under 12 years of age: oral dosage is 2 milligrams every 4 to 6 hours,
not to exceed 12 milligrams in 24 hours, or as directed by a doctor.
Children under 6 years of age: consult a doctor.
(2) For products containing chlorcyclizine hydrochloride identified
in Sec. 341.12(b). Adults and children 12 years of age and over: oral
dosage is 25 milligrams every 6 to 8 hours, not to exceed 75 milligrams
in 24 hours, or as directed by a doctor. Children under 12 years of age:
consult a doctor.
(3) For products containing chlorpheniramine maleate identified in
Sec. 341.12(c). Adults and children 12 years of age and over: oral
dosage is 4 milligrams every 4 to 6 hours, not to exceed 24 milligrams
in 24 hours, or as directed by a doctor. Children 6 to under 12 years of
age: oral dosage is 2 milligrams every 4 to 6 hours, not to exceed 12
milligrams in 24 hours, or as directed by a doctor. Children under 6
years of age: consult a doctor.
(4) For products containing dexbrompheniramine maleate identified in
Sec. 341.12(d). Adults and children 12 years of age and over: oral
dosage is 2 milligrams every 4 to 6 hours, not to exceed 12 milligrams
in 24 hours, or as directed by a doctor. Children 6 to under 12 years of
age: oral dosage is 1 milligram every 4 to 6 hours, not to exceed 6
milligrams in 24 hours, or as directed by a doctor. Children under 6
years of age: consult a doctor.
(5) For products containing dexchlorpheniramine maleate identified
in Sec. 341.12(e). Adults and children 12 years of age and over: oral
dosage is 2 milligrams every 4 to 6 hours, not to exceed 12 milligrams
in 24 hours, or as directed by a doctor. Children 6 to under 12 years of
age: oral dosage is 1 milligram every 4 to 6 hours, not to exceed 6
milligrams in 24 hours, or as directed by a doctor. Children under 6
years of age: consult a doctor.
(6) For products containing diphenhydramine citrate identified in
Sec. 341.12(f). Adults and children 12 years of age and over: oral
dosage is 38 to 76 milligrams every 4 to 6 hours, not to exceed 456
milligrams in 24 hours, or as directed by a doctor. Children 6 to under
12 years of age: oral dosage is 19 to 38 milligrams every 4 to 6 hours,
not to exceed 228 milligrams in 24 hours, or as directed by a doctor.
Children under 6 years of age: consult a doctor.
(7) For products containing diphenhydramine hydrochloride identified
in Sec. 341.12(g). Adults and children 12 years of age and over: oral
dosage is 25 to 50 milligrams every 4 to 6 hours, not to exceed 300
milligrams in 24 hours, or as directed by a doctor. Children 6 to under
12 years of age: oral dosage is 12.5 to 25 milligrams every 4 to 6
hours, not to exceed 150 milligrams in 24 hours, or as directed by a
doctor. Children under 6 years of age: consult a doctor.
(8) For products containing doxylamine succinate identified in
Sec. 341.12(h). Adults and children 12 years of age and over: oral
dosage is 7.5 to 12.5 milligrams every 4 to 6 hours, not to exceed 75
milligrams in 24 hours, or as directed by a doctor. Children 6 to under
12 years of age: oral dosage is 3.75 to 6.25 milligrams every 4 to 6
hours, not to exceed 37.5 milligrams in 24 hours, or as directed by a
doctor. Children under 6 years of age: consult a doctor.
(9) For products containing phenindamine tartrate identified in
Sec. 341.12(i). Adults and children 12 years of age and over: oral
dosage is 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams
in 24 hours, or as directed by a doctor. Children 6 to under 12 years of
age: oral dosage is 12.5 milligrams every 4 to 6 hours, not to exceed 75
milligrams in 24 hours, or as directed by a doctor. Children under 6
years of age: consult a doctor.
(10) For products containing pheniramine maleate identified in
Sec. 341.12(j). Adults and children 12 years of age and over: oral
dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150
milligrams in 24 hours, or as directed by a doctor. Children 6 to under
12 years of age: oral dosage is 6.25 to 12.5 milligrams every 4 to 6
hours, not to exceed 75 milligrams in 24 hours, or as directed by a
doctor. Children under 6 years of age: consult a doctor.
(11) For products containing pyrilamine maleate identified in
Sec. 341.12(k). Adults and children 12 years of age and over: oral
dosage is 25 to 50 milligrams every
[[Page 240]]
6 to 8 hours, not to exceed 200 milligrams in 24 hours, or as directed
by a doctor. Children 6 to under 12 years of age: oral dosage is 12.5 to
25 milligrams every 6 to 8 hours, not to exceed 100 milligrams in 24
hours, or as directed by a doctor. Children under 6 years of age:
consult a doctor.
(12) For products containing thonzylamine hydrochloride identified
in Sec. 341.12(l). Adults and children 12 years of age and over: oral
dosage is 50 to 100 milligrams every 4 to 6 hours, not to exceed 600
milligrams in 24 hours, or as directed by a doctor. Children 6 to under
12 years of age: oral dosage is 25 to 50 milligrams every 4 to 6 hours,
not to exceed 300 milligrams in 24 hours, or as directed by a doctor.
Children under 6 years of age: consult a doctor.
(13) For products containing triprolidine hydrochloride identified
in Sec. 341.12(m). Adults and children 12 years of age and over: oral
dosage is 2.5 milligrams every 4 to 6 hours, not to exceed 10 milligrams
in 24 hours, or as directed by a doctor. Children 6 to under 12 years of
age: oral dosage is 1.25 milligrams every 4 to 6 hours, not to exceed 5
milligrams in 24 hours, or as directed by a doctor. Children under 6
years of age: consult a doctor.
(e) The word ``physician'' may be substituted for the word
``doctor'' in any of the labeling statements in this section.
[57 FR 58374, Dec. 9, 1992, as amended at 59 FR 4218, Jan. 28, 1994]
Sec. 341.74 Labeling of antitussive drug products.
(a) Statement of identity. The labeling of the product contains the
established name of the drug, if any, and identifies the product as a
``cough suppressant'' or an ``antitussive (cough suppressant).''
(b) Indications. The labeling of the product states, under the
heading ``Indications,'' any of the phrases listed in this paragraph
(b), as appropriate. Other truthful and nonmisleading statements,
describing only the indications for use that have been established and
listed in this paragraph, may also be used, as provided in
Sec. 330.1(c)(2), subject to the provisions of section 502 of the act
relating to misbranding and the prohibition in section 301(d) of the act
against the introduction or delivery for introduction into interstate
commerce of unapproved new drugs in violation of section 505(a) of the
act.
(1) ``Temporarily'' (select one of the following: ``alleviates,''
``calms,'' ``controls,'' ``decreases,'' ``quiets,'' ``reduces,''
``relieves,'' or ``suppresses'') ``cough due to'' (select one of the
following: ``minor bronchial irritation'' or ``minor throat and
bronchial irritation'') (select one of the following: ``as may occur
with,'' ``associated with,'' or ``occurring with'') (select one of the
following: ``A cold'' or ``the common cold'') ``or inhaled irritants.''
(2) ``Temporarily'' (select one of the following: ``alleviates,''
``calms,'' ``controls,'' ``decreases,'' ``quiets,'' ``reduces,''
``relieves,'' or ``suppresses'') ``cough'' (select one of the following:
``as may occur with,'' ``associated with,'' or ``occurring with'')
(select one of the following: ``A cold,'' ``the common cold,'' or
``inhaled irritants'').
(3) In addition to the required information identified in paragraphs
(b) (1) and (2) of this section, the labeling of the product may contain
any (one or more) of the following statements:
(i) ``Cough suppressant which temporarily'' (select one of the
following: ``Alleviates,'' ``controls,'' ``decreases,'' ``reduces,''
``relieves,'' or ``suppresses'') ``the impulse to cough.''
(ii) ``Temporarily helps you cough less.''
(iii) ``Temporarily helps to'' (select one of the following:
``Alleviate,'' ``control,'' ``decrease,'' ``reduce,'' ``relieve,'' or
``suppress'') ``the cough reflex that causes coughing.''
(iv) ``Temporarily'' (select one of the following: ``Alleviates,''
``controls,'' ``decreases,'' ``reduces,'' ``relieves,'' or
``suppresses'') ``the intensity of coughing.''
(v) (Select one of the following: ``Alleviates,'' ``Controls,''
``Decreases,'' ``Reduces,'' ``Relieves,'' or ``Suppresses'') (select one
of the following: ``Cough,'' ``the impulse to cough,'' or ``your
cough'') ``to help you'' (select one of the following: ``Get to sleep,''
``sleep,'' or ``rest'').
(vi) For products containing chlophedianol hydrochloride, codeine
ingredients, dextromethorphan, or
[[Page 241]]
dextromethorphan hydrobromide identified in Sec. 341.14(a) (1), (2),
(3), and (4). ``Calms the cough control center and relieves coughing.''
(vii) For products containing chlophedianol hydrochloride,
dextromethorphan, dextromethorphan hydrobromide, camphor, or menthol
identified in Sec. 341.14(a) (1), (3), (4) and (b) (1) and (2). (a)
``Nonnarcotic cough suppressant for the temporary'' (select one of the
following: ``alleviation,'' ``control,'' ``decrease,'' ``reduction,''
``relief,'' or ``suppression'') ``of cough.''
(b) (Select one of the following: ``Alleviates,'' ``Controls,''
``Decreases,'' ``Reduces,'' ``Relieves,'' or ``Suppresses'') ``cough
impulses without narcotics.''
(c) Warnings. The labeling of the product contains the following
warnings under the heading ``Warnings'':
(1) For oral and topical antitussives. ``A persistent cough may be a
sign of a serious condition. If cough persists for more than 1 week,
tends to recur, or is accompanied by fever, rash, or persistent
headache, consult a doctor.''
(2) For oral and topical antitussives labeled for adults or for
adults and children under 12 years of age. ``Do not take this product
for persistent or chronic cough such as occurs with smoking, asthma, or
emphysema, or if cough is accompanied by excessive phlegm (mucus) unless
directed by a doctor.''
(3) For oral and topical antitussives labeled only for children
under 12 years of age. ``Do not give this product for persistent or
chronic cough such as occurs with asthma or if cough is accompanied by
excessive phlegm (mucus) unless directed by a doctor.''
(4) Oral antitussives--(i) For products containing codeine
ingredients identified in Sec. 341.14(a)(2). ``May cause or aggravate
constipation.''
(ii) For products containing codeine ingredients identified in
Sec. 341.14(a)(2) when labeled only for adults. ``Do not take this
product if you have a chronic pulmonary disease or shortness of breath
unless directed by a doctor.''
(iii) For products containing codeine ingredients identified in
Sec. 341.14(a)(2) when labeled only for children under 12 years of age.
``Do not give this product to children who have a chronic pulmonary
disease, shortness of breath, or who are taking other drugs unless
directed by a doctor.''
(iv) For products containing codeine ingredients identified in
Sec. 341.14(a)(2) when labeled for use in adults and children under 12
years of age. ``Adults and children who have a chronic pulmonary disease
or shortness of breath, or children who are taking other drugs, should
not take this product unless directed by a doctor.''
(v) For products containing dextromethorphan or dextromethorphan
hydrobromide as identified in Sec. 341.14(a)(3) and (a)(4) when labeled
for adults or for adults and children under 12 years of age. Drug
interaction precaution. ``Do not use if you are now taking a
prescription monoamine oxidase inhibitor (MAOI) (certain drugs for
depression, psychiatric, or emotional conditions, or Parkinson's
disease), or for 2 weeks after stopping the MAOI drug. If you do not
know if your prescription drug contains an MAOI, ask a doctor or
pharmacist before taking this product.''
(vi) For products containing dextromethorphan or dextromethorphan
hydrobromide as identified in Sec. 341.14(a)(3) and (a)(4) when labeled
only for children under 12 years of age. Drug interaction precaution.
``Do not use in a child who is taking a prescription monoamine oxidase
inhibitor (MAOI) (certain drugs for depression, psychiatric, or
emotional conditions, or Parkinson's disease), or for 2 weeks after
stopping the MAOI drug. If you do not know if your child's prescription
drug contains an MAOI, ask a doctor or pharmacist before giving this
product.''
(vii) For products containing diphenhydramine citrate or
diphenhydramine hydrochloride identified in Sec. 341.14(a)(5) and
(a)(6). ``May cause excitability especially in children.''
(viii) For products containing diphenhydramine citrate or
diphenhydramine hydrochloride identified in Sec. 341.14(a)(5) and (a)(6)
when labeled only for children under 12 years of age--(A) ``Do not give
this product to children who have a breathing problem such as chronic
bronchitis, or who have glaucoma, without first consulting the child's
doctor.''
[[Page 242]]
(B) ``May cause marked drowsiness. Sedatives and tranquilizers may
increase the drowsiness effect. Do not give this product to children who
are taking sedatives or tranquilizers, without first consulting the
child's doctor.''
(ix) For products containing diphenhydramine citrate or
diphenhydramine hydrochloride identified in Sec. 341.14(a)(5) and (a)(6)
when labeled for use in adults and children under 12 years of age--(A)
``Do not take this product, unless directed by a doctor, if you have a
breathing problem such as emphysema or chronic bronchitis, or if you
have glaucoma or difficulty in urination due to enlargement of the
prostate gland.''
(B) ``May cause marked drowsiness; alcohol, sedatives, and
tranquilizers may increase the drowsiness effect. Avoid alcoholic
beverages while taking this product. Do not take this product if you are
taking sedatives or tranquilizers, without first consulting your doctor.
Use caution when driving a motor vehicle or operating machinery.''
(5) Topical antitussives--(i) For products containing camphor or
menthol identified in Sec. 341.14(b) (1) and (2) in a suitable ointment
vehicle. ``For external use only. Do not take by mouth or place in
nostrils.''
(ii) For products containing camphor or menthol identified in
Sec. 341.14(b) (1) and (2) for steam inhalation use. ``For steam
inhalation only. Do not take by mouth.''
(d) Directions. The labeling of the product contains the following
information under the heading ``Directions'':
(1) Oral antitussives--(i) For products containing chlophedianol
hydrochloride identified in Sec. 341.14(a)(1). Adults and children 12
years of age and over: Oral dosage is 25 milligrams every 6 to 8 hours,
not to exceed 100 milligrams in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age: Oral dosage is 12.5 milligrams
every 6 to 8 hours, not to exceed 50 milligrams in 24 hours, or as
directed by a doctor. Children under 6 years of age: Consult a doctor.
(ii) For products containing codeine ingredients identified in
Sec. 341.14(a)(2). Adults and children 12 years of age and over: Oral
dosage is 10 to 20 milligrams every 4 to 6 hours, not to exceed 120
milligrams in 24 hours, or as directed by a doctor. Children 6 to under
12 years of age: Oral dosage is 5 to 10 milligrams every 4 to 6 hours,
not to exceed 60 milligrams in 24 hours, or as directed by a doctor.
Children under 6 years of age: Consult a doctor. A special measuring
device should be used to give an accurate dose of this product to
children under 6 years of age. Giving a higher dose than recommended by
a doctor could result in serious side effects for your child.
(iii) For products containing dextromethorphan or dextromethorphan
hydrobromide identified in Sec. 341.14(a) (3) and (4). The dosage is
equivalent to dextromethorphan hydrobromide. Adults and children 12
years of age and over: Oral dosage is 10 to 20 milligrams every 4 hours
or 30 milligrams every 6 to 8 hours, not to exceed 120 milligrams in 24
hours, or as directed by a doctor. Children 6 to under 12 years of age:
Oral dosage is 5 to 10 milligrams every 4 hours or 15 milligrams every 6
to 8 hours, not to exceed 60 milligrams in 24 hours, or as directed by a
doctor. Children 2 to under 6 years of age: Oral dosage is 2.5 to 5
milligrams every 4 hours or 7.5 milligrams every 6 to 8 hours, not to
exceed 30 milligrams in 24 hours, or as directed by a doctor. Children
under 2 years of age: Consult a doctor.
(iv) For products containing diphenhydramine citrate identified in
Sec. 341.14(a)(5). Adults and children 12 years of age and over: oral
dosage is 38 milligrams every 4 hours, not to exceed 228 milligrams in
24 hours, or as directed by a doctor. Children 6 to under 12 years of
age: oral dosage is 19 milligrams every 4 hours, not to exceed 114
milligrams in 24 hours, or as directed by a doctor. Children under 6
years of age: consult a doctor.
(v) For products containing diphenhydramine hydrochloride identified
in Sec. 341.14(a)(6). Adults and children 12 years of age and over: oral
dosage is 25 milligrams every 4 hours, not to exceed 150 milligrams in
24 hours, or as directed by a doctor. Children 6 to under 12 years of
age: oral dosage is 12.5 milligrams every 4 hours, not to exceed 75
milligrams in 24 hours, or as directed by a doctor. Children under 6
years of age: consult a doctor.
[[Page 243]]
(2) Topical antitussives--(i) For products containing camphor
identified in Sec. 341.14(b)(1) in a suitable ointment vehicle. The
product contains 4.7 to 5.3 percent camphor. Adults and children 2 to
under 12 years of age: Rub on the throat and chest as a thick layer. The
area of application may be covered with a warm, dry cloth if desired.
However, clothing should be left loose about the throat and chest to
help the vapors rise to reach the nose and mouth. Applications may be
repeated up to three times daily or as directed by a doctor. Children
under 2 years of age: consult a doctor.
(ii) For products containing menthol identified in Sec. 341.14(b)(2)
in a suitable ointment vehicle. The product contains 2.6 to 2.8 percent
menthol. Adults and children 2 to under 12 years of age: Rub on the
throat and chest as a thick layer. The area of application may be
covered with a warm, dry cloth if desired. However, clothing should be
left loose about the throat and chest to help the vapors rise to reach
the nose and mouth. Applications may be repeated up to three times daily
or as directed by a doctor. Children under 2 years of age: consult a
doctor.
(iii) For products containing menthol identified in
Sec. 341.14(b)(2) in a lozenge. The product contains 5 to 10 milligrams
menthol. Adults and children 2 to under 12 years of age: Allow lozenge
to dissolve slowly in the mouth. May be repeated every hour as needed or
as directed by a doctor. Children under 2 years of age: Consult a
doctor.
(iv) For products containing camphor identified in Sec. 341.14(b)(1)
for steam inhalation use. The product contains 6.2 percent camphor.
Adults and children 2 to under 12 years of age: Add 1 tablespoonful of
solution, for each quart of water, directly to the water in a hot steam
vaporizer, bowl, or wash basin; or add 1\1/2\ teaspoonsful of solution,
for each pint of water, to an open container of boiling water. Breathe
in the medicated vapors. May be repeated up to three times daily or as
directed by a doctor. Children under 2 years of age: consult a doctor.
(v) For products containing menthol identified in Sec. 341.14(b)(2)
for steam inhalation use. The product contains 3.2 percent menthol.
Adults and children 2 to under 12 years of age: Add 1 tablespoonful of
solution, for each quart of water, directly to the water in a hot steam
vaporizer, bowl, or wash basin; or add 1\1/2\ teaspoonsful of solution,
for each pint of water, to an open container of boiling water. Breathe
in the medicated vapors. May be repeated up to three times daily or as
directed by a doctor. Children under 2 years of age: consult a doctor.
(e) The word ``physician'' may be substituted for the word
``doctor'' in any of the labeling statements in this section.
(f) Exemption from the general accidental overdose warning. The
labeling for antitussive drug products containing the active ingredient
identified in Sec. 341.14(b)(2) marketed in accordance with
Sec. 341.74(d)(2)(iii) is exempt from the requirement in Sec. 330.1(g)
of this chapter that the labeling bear the general warning statement
``In case of accidental overdose, seek professional assistance or
contact a poison control center immediately.'' The labeling must
continue to bear the first part of the general warning in Sec. 330.1(g)
of this chapter, which states, ``Keep this and all drugs out of the
reach of children.''
[52 FR 30055, Aug. 12, 1987; 52 FR 35610, Sept. 22, 1987; 53 FR 35809,
Sept. 15, 1988; 55 FR 27808, July 6, 1990; 55 FR 40383, Oct. 3, 1990; 58
FR 54236, Oct. 20, 1993; 59 FR 29174, June 3, 1994; 59 FR 36051, July
15, 1994; 64 FR 13295, Mar. 17, 1999; 65 FR 8, Jan. 3, 2000]
Effective Date Note: At 65 FR 46867, Aug. 1, 2000, Sec. 341.74 was
amended by adding new paragraphs (c)(5)(iii) through (c)(5)(vii), and by
revising paragraphs (d)(2)(i), (d)(2)(ii), (d)(2)(iv), and (d)(2)(v),
effective May 16, 2002. For the convenience of the user, the revised
text is set forth as follows:
Sec. 341.74 Labeling of antitussive drug products.
* * * * *
(c) * * *
(5) * * *
(iii) For any product containing camphor or menthol in a suitable
ointment vehicle or for steam inhalation use and meets the definition of
one of the signal words (``extremely flammable,'' ``flammable,''
``combustible'') as described in 16 CFR 1500.3(b)(10). The labeling
contains the appropriate flammability signal word(s) followed by a colon
and the statement ``Keep away from fire or flame.''
[[Page 244]]
(iv) For any product containing camphor or menthol in a suitable
ointment vehicle and that does not contain a flammability signal word as
described in 16 CFR 1500.3(b)(10). ``When using this product, do not
[bullet] \1\ heat [bullet] microwave [bullet] add to hot water or any
container where heating water. May cause splattering and result in
burns.'' [Information highlighted in bold type.]
---------------------------------------------------------------------------
\1\ For a definition of the term ``bullet,'' see Sec. 201.66(b)(4)
of this chapter.
---------------------------------------------------------------------------
(v) For any product containing camphor or menthol in a suitable
ointment vehicle and that contains a flammability signal word as
described in 16 CFR 1500.3(b)(10). ``When using this product, do not
[bullet] heat [bullet] microwave [bullet] use near an open flame
[bullet] add to hot water or any container where heating water. May
cause splattering and result in burns.'' [Information highlighted in
bold type.]
(vi) For any product containing camphor or menthol for steam
inhalation use. ``When using this product, do not [bullet] heat [bullet]
microwave [bullet] use near an open flame [bullet] add to hot water or
any container where heating water except when adding to cold water only
in a hot steam vaporizer. May cause splattering and result in burns.''
[Information highlighted in bold type.]
(vii) For any product formulated in a volatile vehicle. The labeling
contains the following statement under the heading ``Other
information'': ``Close container tightly and store at room temperature
away from heat.''
(d) * * *
(2) * * *
(i) For products containing camphor identified in Sec. 341.14(b)(1)
in a suitable ointment vehicle. The product contains 4.7 to 5.3 percent
camphor. ``[bullet] see important warnings under `When using this
product' '' [appears as the first statement under the heading
``Directions'' and is highlighted in bold type] [bullet] adults and
children 2 years and older: [bullet] rub on the throat and chest in a
thick layer [bullet] cover with a warm, dry cloth if desired [bullet]
clothing should be loose about throat and chest to help vapors reach the
nose and mouth [bullet] use up to three times daily or as directed by a
doctor [bullet] children under 2 years of age: Ask a doctor.
(ii) For products containing menthol identified in Sec. 341.14(b)(2)
in a suitable ointment vehicle. The product contains 2.6 to 2.8 percent
menthol. ``[bullet] see important warnings under `When using this
product' '' [appears as the first statement under the heading
``Directions'' and is highlighted in bold type] [bullet] adults and
children 2 years and older: [bullet] rub on the throat and chest in a
thick layer [bullet] cover with a warm, dry cloth if desired [bullet]
clothing should be loose about throat and chest to help vapors reach the
nose and mouth [bullet] use up to three times daily or as directed by a
doctor [bullet] children under 2 years of age: Ask a doctor.
* * * * *
(iv) For products containing camphor identified in Sec. 341.14(b)(1)
for steam inhalation use. The product contains 6.2 percent camphor.
``[bullet] see important warnings under `When using this product' ''
[appears as the first statement under the heading ``Directions'' and is
highlighted in bold type] [bullet] adults and children 2 years and
older: (select one of the following, as appropriate: For products
formulated to be added directly to cold water inside a hot steam
vaporizer. [bullet] use 1 tablespoonful of solution for each quart of
water or 1\1/2\ teaspoonsful of solution for each pint of water [bullet]
add solution directly to cold water only in a hot steam vaporizer
[bullet] follow manufacturer's directions for using vaporizer or For
products formulated to be placed in the medication chamber of a hot
steam vaporizer. [bullet] place water in the vaporizer and follow
manufacturer's directions for using vaporizer [bullet] place solution in
the medication chamber only) [bullet] breathe in the medicated vapors
[bullet] use up to three times daily or as directed by a doctor [bullet]
children under 2 years of age: Ask a doctor.
(v) For products containing menthol identified in Sec. 341.14(b)(2)
for steam inhalation use. The product contains 3.2 percent menthol.
``[bullet] see important warnings under `When using this product'
''[appears as the first statement under the heading ``Directions'' and
is highlighted in bold type] [bullet] adults and children 2 years and
older: (select one of the following, as appropriate: For products
formulated to be added directly to cold water inside a hot steam
vaporizer. [bullet] use 1 tablespoonful of solution for each quart of
water or 1\1/2\ teaspoonsful of solution for each pint of water [bullet]
add solution directly to cold water only in a hot steam vaporizer
[bullet] follow manufacturer's directions for using vaporizer or For
products formulated to be placed in the medication chamber of a hot
steam vaporizer. [bullet] place water in the vaporizer and follow
manufacturer's directions for using vaporizer [bullet] place solution in
the medication chamber only) [bullet] breathe in the medicated vapors
[bullet] use up to three times daily or as directed by a doctor [bullet]
children under 2 years of age: Ask a doctor.
* * * * *
Sec. 341.76 Labeling of bronchodilator drug products.
(a) Statement of identity. The labeling of the product contains the
established
[[Page 245]]
name of the drug, if any, and identifies the product as a
``bronchodilator.''
(b) Indications. The labeling of the product states, under the
heading ``Indications,'' the phrase listed in paragraph (b)(1) of this
section. Other truthful and nonmisleading statements, describing only
the indications for use that have been established and listed in this
paragraph (b), may also be used, as provided in Sec. 330.1(c)(2),
subject to the provisions of section 502 of the act relating to
misbranding and the prohibition in section 301(d) of the act against the
introduction or delivery for introduction into interstate commerce of
unapproved new drugs in violation of section 505(a) of the act.
(1) ``For temporary relief of shortness of breath, tightness of
chest, and wheezing due to bronchial asthma.''
(2) In addition to the required information identified in paragraph
(b)(1) of this section, the labeling of the product may contain one or
more of the following statements:
(i) ``For the'' (select one of the following: ``temporary relief''
or ``symptomatic control'') ``of bronchial asthma.''
(ii) ``Eases breathing for asthma patients'' (which may be followed
by: ``by reducing spasms of bronchial muscles'').
(c) Warnings. The labeling of the product contains the following
warnings under the heading ``Warnings'':
(1) ``Do not use this product unless a diagnosis of asthma has been
made by a doctor.''
(2) ``Do not use this product if you have heart disease, high blood
pressure, thyroid disease, diabetes, or difficulty in urination due to
enlargement of the prostate gland unless directed by a doctor.''
(3) ``Do not use this product if you have ever been hospitalized for
asthma or if you are taking any prescription drug for asthma unless
directed by a doctor.''
(4) Drug interaction precaution. ``Do not use if you are now taking
a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for
depression, psychiatric, or emotional conditions, or Parkinson's
disease), or for 2 weeks after stopping the MAOI drug. If you do not
know if your prescription drug contains an MAOI, ask a doctor or
pharmacist before taking this product.''
(5) For products containing ephedrine, ephedrine hydrochloride,
ephedrine sulfate, or racephedrine hydrochloride identified in
Sec. 341.16 (a), (b), (c), and (f). (i) ``Do not continue to use this
product, but seek medical assistance immediately if symptoms are not
relieved within 1 hour or become worse.''
(ii) ``Some users of this product may experience nervousness,
tremor, sleeplessness, nausea, and loss of appetite. If these symptoms
persist or become worse, consult your doctor.''
(6) For products containing epinephrine, epinephrine bitartrate, or
racepinephrine hydrochloride identified in Sec. 341.16 (d), (e), and
(g). (i) ``Do not use this product more frequently or at higher doses
than recommended unless directed by a doctor. [first sentence in
boldface type] Excessive use may cause nervousness and rapid heart beat,
and, possibly, adverse effects on the heart.''
(ii) ``Do not continue to use this product, but seek medical
assistance immediately if symptoms are not relieved within 20 minutes or
become worse.'' [sentence in boldface type]
(iii) For products intended for use in a hand-held rubber bulb
nebulizer. ``Do not use this product if it is brown in color or
cloudy.''
(d) Directions. The labeling of the product contains the following
information under the heading ``Directions'':
(1) For products containing ephedrine, ephedrine hydrochloride,
ephedrine sulfate, or racephedrine hydrochloride identified in
Sec. 341.16 (a), (b), (c), and (f). Adults and children 12 years of age
and over: Oral dosage is 12.5 to 25 milligrams every 4 hours, not to
exceed 150 milligrams in 24 hours, or as directed by a doctor. Do not
exceed recommended dose unless directed by a doctor. Children under 12
years of age: Consult a doctor.
(2) For products containing epinephrine, epinephrine bitartrate, and
racepinephrine hydrochloride identified in Sec. 341.16(d), (e), and (g)
for use in a hand-held rubber bulb nebulizer. The ingredient is used in
an aqueous solution at a concentration equivalent to 1 percent
epinephrine. Inhalation dosage for adults, children 12 years of age and
[[Page 246]]
over, and children 4 to under 12 years of age: 1 to 3 inhalations not
more often than every 3 hours. The use of this product by children
should be supervised by an adult. Children under 4 years of age: Consult
a doctor.
(Collection of information requirement approved by the Office of
Management and Budget under control number 0910-0237)
[51 FR 35339, Oct. 2, 1986, as amended at 52 FR 7126, Mar. 9, 1987; 52
FR 7830, Mar. 13, 1987; 53 FR 35810, Sept. 15, 1988; 58 FR 54242, Oct.
20, 1993; 61 FR 25146, May 20, 1996; 62 FR 9684, Mar. 4, 1997; 64 FR
13295, Mar. 17, 1999]
Sec. 341.78 Labeling of expectorant drug products.
(a) Statement of identity. The labeling of the product contains the
established name of the drug, if any, and identifies the product as an
``expectorant.''
(b) Indications. The labeling of the product states, under the
heading ``Indications,'' the following: ``Helps loosen phlegm (mucus)
and thin bronchial secretions to'' (select one or more of the following:
``rid the bronchial passageways of bothersome mucus,'' ``drain bronchial
tubes,'' and ``make coughs more productive''). Other truthful and
nonmisleading statements, describing only the indications for use that
have been established and listed in this paragraph (b), may also be
used, as provided in Sec. 330.1(c)(2) of this chapter, subject to the
provisions of section 502 of the act relating to misbranding and the
prohibition in section 301(d) of the act against the introduction or
delivery for introduction into interstate commerce of unapproved new
drugs in violation of section 505(a) of the act.
(c) Warnings. The labeling of the product contains the following
warnings, under the heading ``Warnings'':
(1) ``A persistent cough may be a sign of a serious condition. If
cough persists for more than 1 week, tends to recur, or is accompanied
by a fever, rash, or persistent headache, consult a doctor.''
(2) For expectorant drug products labeled for adults or for adults
and children under 12 years of age. ``Do not take this product for
persistent or chronic cough such as occurs with smoking, asthma, chronic
bronchitis, or emphysema, or where cough is accompanied by excessive
phlegm (mucus) unless directed by a doctor.''
(3) For expectorant drug products labeled only for children under 12
years of age. ``Do not give this product for persistent or chronic cough
such as occurs with asthma or if cough is accompanied by excessive
phlegm (mucus) unless directed by a doctor.''
(d) Directions. The labeling of the product contains the following
information under the heading ``Directions'' for products containing
guaifenesin identified in Sec. 341.18: Adults and children 12 years of
age and over: oral dosage is 200 to 400 milligrams every 4 hours not to
exceed 2,400 milligrams in 24 hours. Children 6 to under 12 years of
age: oral dosage is 100 to 200 milligrams every 4 hours not to exceed
1,200 milligrams in 24 hours. Children 2 to under 6 years of age: oral
dosage is 50 to 100 milligrams every 4 hours not to exceed 600
milligrams in 24 hours. Children under 2 years of age: consult a doctor.
(e) The word ``physician'' may be substituted for the word
``doctor'' in any of the labeling statements in this section.
[54 FR 8509, Feb. 28, 1989, as amended at 57 FR 29177, June 30, 1992]
Sec. 341.80 Labeling of nasal decongestant drug products.
(a) Statement of identity. The labeling of the product contains the
established name of the drug, if any, and identifies the product as a
``nasal decongestant.''
(b) Indications. The labeling of the product states, under the
heading ``Indications,'' the phrase listed in paragraph (b)(1) of this
section, as appropriate, and may contain any additional phrases listed
in paragraph (b)(2) of this section. Other truthful and nonmisleading
statements, describing only the indications for use that have been
established and listed in paragraphs (b)(1) and (b)(2) of this section,
may also be used, as provided in Sec. 330.1(c)(2) of this chapter,
subject to the provisions of section 502 of the Federal Food, Drug, and
Cosmetic Act (the act) relating to misbranding and the prohibition in
section 301(d) of the act against the introduction or delivery for
introduction into interstate commerce of unapproved new drugs in
violation of section 505(a) of the act.
[[Page 247]]
(1) (Select one of the following: ``For the temporary relief of
nasal congestion'' or ``Temporarily relieves nasal congestion'') (which
may be followed by any of the following in paragraphs (b)(1) (i), (ii),
and (iii) of this section):
(i) ``due to'' (select one of the following: ``the common cold'' or
``a cold'').
(ii) ``due to'' (select one of the following: ``hay fever,'' ``hay
fever (allergic rhinitis),'' ``hay fever or other upper respiratory
allergies,'' or ``hay fever or other upper respiratory allergies
(allergic rhinitis)'').
(iii) ``associated with sinusitis.''
(2) In addition to the information identified in paragraph (b)(1) of
this section, the labeling of the product may contain any (one or more)
of the following statements:
(i) (Select one of the following: ``For the temporary relief of'' or
``Temporarily relieves'') (select one of the following: ``stuffy nose,''
``stopped up nose,'' ``nasal stuffiness,'' or ``clogged up nose.'')
(ii) (Select one of the following: ``Reduces swelling of,''
``Decongests,'' or ``Helps clear'') ``nasal passages; shrinks swollen
membranes.''
(iii) ``Temporarily restores freer breathing through the nose.''
(iv) ``Helps decongest sinus openings and passages; temporarily
relieves sinus congestion and pressure.''
(v) ``Promotes nasal and/or sinus drainage; temporarily relieves
sinus congestion and pressure.''
(c) Warnings. The labeling of the product contains the following
warnings under the heading ``Warnings'':
(1) Oral nasal decongestants--(i) For products containing
phenylephrine hydrochloride, pseudoephedrine hydrochloride, or
pseudoephedrine sulfate identified in Sec. 341.20 (a)(1), (a)(2), and
(a)(3) when labeled for adults. (A) ``Do not exceed recommended dosage.
[first sentence in boldface type] If nervousness, dizziness, or
sleeplessness occur, discontinue use and consult a doctor.''
(B) ``If symptoms do not improve within 7 days or are accompanied by
fever, consult a doctor.''
(C) ``Do not take this product if you have heart disease, high blood
pressure, thyroid disease, diabetes, or difficulty in urination due to
enlargement of the prostate gland unless directed by a doctor.''
(D) Drug interaction precaution. ``Do not use if you are now taking
a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for
depression, psychiatric, or emotional conditions, or Parkinson's
disease), or for 2 weeks after stopping the MAOI drug. If you do not
know if your prescription drug contains an MAOI, ask a doctor or
pharmacist before taking this product.''
(ii) For products containing phenylephrine hydrochloride,
pseudoephedrine hydrochloride, or pseudoephedrine sulfate identified in
Sec. 341.20 (a)(1), (a)(2), and (a)(3) when labeled for children under
12 years of age. (A) ``Do not exceed recommended dosage. [first sentence
in boldface type] If nervousness, dizziness, or sleeplessness occur,
discontinue use and consult a doctor.''
(B) ``If symptoms do not improve within 7 days or are accompanied by
fever, consult a doctor.''
(C) ``Do not give this product to a child who has heart disease,
high blood pressure, thyroid disease, or diabetes unless directed by a
doctor.''
(D) Drug interaction precaution. ``Do not use in a child who is
taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs
for depression, psychiatric, or emotional conditions, or Parkinson's
disease), or for 2 weeks after stopping the MAOI drug. If you do not
know if your child's prescription drug contains an MAOI, ask a doctor or
pharmacist before giving this product.''
(iii) For oral nasal decongestant products labeled for both adults
and children under 12 years of age. The labeling of the product contains
the warnings identified in paragraph (c)(1)(i) of this section.
(2) Topical nasal decongestants--(i) For products containing any
topical nasal decongestant identified in Sec. 341.20(b) when labeled for
adults. (A) ``Do not exceed recommended dosage.'' [sentence in boldface
type]
(B) ``This product may cause temporary discomfort such as burning,
stinging, sneezing, or an increase in nasal discharge.''
(C) ``The use of this container by more than one person may spread
infection.''
[[Page 248]]
(ii) For products containing levmetamfetamine identified in
Sec. 341.20(b)(1) when used in an inhalant dosage form and when labeled
for adults. ``Do not use this product for more than 7 days. Use only as
directed. Frequent or prolonged use may cause nasal congestion to recur
or worsen. If symptoms persist, ask a doctor.''
(iii) For products containing ephedrine, ephedrine hydrochloride,
ephedrine sulfate, naphazoline hydrochloride, oxymetazoline
hydrochloride, phenylephrine hydrochloride, or xylometazoline
hydrochloride identified in Sec. 341.20 (b)(2), (b)(3), (b)(4), (b)(6),
(b)(7), (b)(8), and (b)(10) when used as nasal sprays, drops, or jellies
and when labeled for adults. (A) ``Do not use this product for more than
3 days. Use only as directed. Frequent or prolonged use may cause nasal
congestion to recur or worsen. If symptoms persist, consult a doctor.''
(B) ``Do not use this product if you have heart disease, high blood
pressure, thyroid disease, diabetes, or difficulty in urination due to
enlargement of the prostate gland unless directed by a doctor.''
(iv) For products containing naphazoline hydrochloride identified in
Sec. 341.20(b)(6) at a concentration of 0.05 percent. ``Do not use this
product in children under 12 years of age because it may cause sedation
if swallowed.''
(v) For products containing propylhexedrine identified in
Sec. 341.20(b)(9) when used in an inhalant dosage form and when labeled
for adults. ``Do not use this product for more than 3 days. Use only as
directed. Frequent or prolonged use may cause nasal congestion to recur
or worsen. If symptoms persist, consult a doctor.''
(vi) For products containing any topical nasal decongestant
identified in Sec. 341.20(b) when labeled for children under 12 years of
age. The labeling of the product contains the warnings identified in
paragraph (c)(2)(i) of this section.
(vii) For products containing levmetamfetamine identified in
Sec. 341.20(b)(1) when used in an inhalant dosage form and when labeled
for children under 12 years of age. ``Do not use this product for more
than 7 days. Use only as directed. Frequent or prolonged use may cause
nasal congestion to recur or worsen. If symptoms persist, ask a
doctor.''
(viii) For products containing ephedrine, ephedrine hydrochloride,
ephedrine sulfate, naphazoline hydrochloride, oxymetazoline
hydrochloride, phenylephrine hydrochloride, or xylometazoline
hydrochloride identified in Sec. 341.20(b)(2), (b)(3), (b)(4), (b)(6),
(b)(7), (b)(8), and (b)(10) when used as nasal sprays, drops, or jellies
and when labeled for children under 12 years of age. (A) ``Do not use
this product for more than 3 days. Use only as directed. Frequent or
prolonged use may cause nasal congestion to recur or worsen. If symptoms
persist, consult a doctor.''
(B) ``Do not use this product in a child who has heart disease, high
blood pressure, thyroid disease, or diabetes unless directed by a
doctor.''
(ix) For products containing propylhexedrine identified in
Sec. 341.20(b)(9) when used in an inhalant dosage form and when labeled
for children under 12 years of age. ``Do not use this product for more
than 3 days. Use only as directed. Frequent or prolonged use may cause
nasal congestion to recur or worsen. If symptoms persist, consult a
doctor.''
(x) For topical nasal decongestant products labeled for both adults
and for children under 12 years of age. The labeling of the product
contains the applicable warnings identified in paragraphs (c)(2)(i),
(c)(2)(ii), (c)(2)(iii), and (c)(2)(v) of this section.
(d) Directions. The labeling of the product contains the following
information under the heading ``Directions'':
(1) Oral nasal decongestants--(i) For products containing
phenylephrine hydrochloride identified in Sec. 341.20(a)(1). Adults and
children 12 years of age and over: 10 milligrams every 4 hours not to
exceed 60 milligrams in 24 hours. Children 6 to under 12 years of age: 5
milligrams every 4 hours not to exceed 30 milligrams in 24 hours.
Children 2 to under 6 years of age: 2.5 milligrams every 4 hours not to
exceed 15 milligrams in 24 hours. Children under 2 years of age: consult
a doctor.
(ii) For products containing pseudoephedrine hydrochloride or
pseudoephedrine sulfate identified in
[[Page 249]]
Sec. 341.20 (a)(2) and (a)(3). Adults and children 12 years of age and
over: 60 milligrams every 4 to 6 hours not to exceed 240 milligrams in
24 hours. Children 6 to under 12 years of age: 30 milligrams every 4 to
6 hours not to exceed 120 milligrams in 24 hours. Children 2 to under 6
years of age: 15 milligrams every 4 to 6 hours not to exceed 60
milligrams in 24 hours. Children under 2 years of age: consult a doctor.
(2) Topical nasal decongestants--(i) For products containing
levmetamfetamine identified in Sec. 341.20(b)(1) when used in an
inhalant dosage form. The product delivers in each 800 milliliters of
air 0.04 to 0.150 milligrams of levmetamfetamine. Adults: 2 inhalations
in each nostril not more often than every 2 hours. Children 6 to under
12 years of age (with adult supervision): 1 inhalation in each nostril
not more often than every 2 hours. Children under 6 years of age: ask a
doctor.
(ii) For products containing ephedrine, ephedrine hydrochloride, or
ephedrine sulfate identified in Sec. 341.20(b) (2), (3), and (4)--(A)
Nasal drops or sprays--For a 0.5-percent aqueous solution. Adults and
children 12 years of age and over: 2 or 3 drops or sprays in each
nostril not more often than every 4 hours. Children 6 to under 12 years
of age (with adult supervision): 1 or 2 drops or sprays in each nostril
not more often than every 4 hours. Children under 6 years of age:
consult a doctor.
(B) Nasal jelly--For a 0.5-percent water-based jelly. Adults and
children 6 to under 12 years of age (with adult supervision): place a
small amount in each nostril and inhale well back into the nasal
passages. Use not more often than every 4 hours.
(iii) For products containing naphazoline hydrochloride identified
in Sec. 341.20(b)(6)--(A) Nasal drops or sprays--(1) For a 0.05-percent
aqueous solution. Adults and children 12 years of age and over: 1 or 2
drops or sprays in each nostril not more often than every 6 hours. Do
not give to children under 12 years of age unless directed by a doctor.
(2) For a 0.025-percent aqueous solution. Children 6 to under 12
years of age (with adult supervision): 1 or 2 drops or sprays in each
nostril not more often than every 6 hours. Children under 6 years of
age: consult a doctor.
(B) Nasal jelly--(1) For a 0.05-percent water-based jelly. Adults
and children 12 years of age and over: place a small amount in each
nostril and inhale well back into the nasal passages. Use not more often
than every 6 hours. Do not give to children under 12 years of age unless
directed by a doctor.
(2) For a 0.025-percent water-based jelly. Children 6 to under 12
years of age (with adult supervision): place a small amount in each
nostril and inhale well back into the nasal passages. Use not more often
than every 6 hours. Children under 6 years of age: consult a doctor.
(iv) For products containing oxymetazoline hydrochloride identified
in Sec. 341.20(b)(7)--(A) Nasal drops or sprays--(1) For a 0.05-percent
aqueous solution. Adults and children 6 to under 12 years of age (with
adult supervision): 2 or 3 drops or sprays in each nostril not more
often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour
period. Children under 6 years of age: consult a doctor.
(2) A 0.025-percent aqueous solution in a container having either a
calibrated dropper or a metered-dose spray that delivers no more than
0.027 milligrams of oxymetazoline per three drops or three sprays.
Children 2 to under 6 years of age (with adult supervision): 2 or 3
drops or sprays in each nostril not more often than every 10 to 12
hours. Use only recommended amount. Do not exceed 2 doses in any 24-hour
period. [previous two sentences in boldface type] Children under 2 years
of age: consult a doctor.
(B) Nasal jelly--For a 0.05-percent water-based jelly. Adults and
children 6 to under 12 years of age (with adult supervision): place a
small amount in each nostril and inhale well back into the nasal
passages. Use not more often than every 10 to 12 hours. Do not exceed 2
doses in any 24-hour period. Children under 6 years of age: consult a
doctor.
(v) For products containing phenylephrine hydrochloride identified
in Sec. 341.20(b)(8)--(A) Nasal drops or sprays--(1) For a 1-percent
aqueous solution. Adults and children 12 years of age and over: 2 or 3
drops or sprays in each nostril not more often than every 4 hours.
[[Page 250]]
Do not give to children under 12 years of age unless directed by a
doctor.
(2) For a 0.5-percent aqueous solution. Adults and children 12 years
of age and over: 2 or 3 drops or sprays in each nostril not more often
than every 4 hours. Do not give to children under 12 years of age unless
directed by a doctor.
(3) For a 0.25-percent aqueous solution. Adults and children 6 to
under 12 years of age (with adult supervision): 2 or 3 drops or sprays
in each nostril not more often than every 4 hours. Children under 6
years of age: consult a doctor.
(4) A 0.125-percent aqueous solution in a container having either a
calibrated dropper or a metered-dose spray that delivers no more than
0.135 milligrams of phenylephrine per three drops or three sprays.
Children 2 to under 6 years of age (with adult supervision): 2 or 3
drops or sprays in each nostril not more often than every 4 hours. Use
only recommended amount. [previous sentence in boldface type] Children
under 2 years of age: consult a doctor.
(B) Nasal jelly--(1) For a 1-percent water-based jelly. Adults and
children 12 years of age and over: place a small amount in each nostril
and inhale well back into the nasal passages. Use not more often than
every 4 hours. Do not give to children under 12 years of age unless
directed by a doctor.
(2) For a 0.5-percent water-based jelly. Adults and children 12
years of age and over: place a small amount in each nostril and inhale
well back into the nasal passages. Use not more often than every 4
hours. Do not give to children under 12 years of age unless directed by
a doctor.
(3) For a 0.25-percent water-based jelly. Adults and children 6 to
under 12 years of age (with adult supervision): place a small amount in
each nostril and inhale well back into the nasal passages. Use not more
often than every 4 hours. Children under 6 years of age: consult a
doctor.
(vi) For products containing propylhexedrine identified in
Sec. 341.20(b)(9) when used in an inhalant dosage form. The product
delivers in each 800 milliliters of air 0.40 to 0.50 milligrams of
propylhexedrine. Adults and children 6 to under 12 years of age (with
adult supervision): 2 inhalations in each nostril not more often than
every 2 hours. Children under 6 years of age: consult a doctor.
(vii) For products containing xylometazoline hydrochloride
identified in Sec. 341.20(b)(10)--(A) Nasal drops or sprays--(1) For a
0.1-percent aqueous solution. Adults and children 12 years of age and
over: 2 or 3 drops or sprays in each nostril not more often than every 8
to 10 hours. Do not give to children under 12 years of age unless
directed by a doctor.
(2) A 0.05-percent aqueous solution in a container having either a
calibrated dropper or a metered-dose spray that delivers no more than
0.054 milligrams of xylometazoline per three drops or three sprays.
Children 6 to under 12 years of age (with adult supervision): 2 or 3
drops or sprays in each nostril not more often than every 8 to 10 hours.
Children 2 to under 6 years of age (with adult supervision): 2 or 3
drops or sprays in each nostril not more often than every 8 to 10 hours.
Use only recommended amount. Do not exceed 3 doses in any 24-hour
period. [previous two sentences in boldface type] Children under 2 years
of age: consult a doctor.
(B) Nasal jelly--(1) For a 0.1-percent water-based jelly. Adults and
children 12 years of age and over: place a small amount in each nostril
and inhale well back into the nasal passages. Use not more often than
every 8 to 10 hours. Do not give to children under 12 years of age
unless directed by a doctor.
(2) For a 0.05-percent water-based jelly. Children 6 to under 12
years of age (with adult supervision): place a small amount in each
nostril and inhale well back into the nasal passages. Use not more often
than every 8 to 10 hours. Children under 6 years of age: consult a
doctor.
(viii) Other required statements--For products containing
levmetamfetamine or propylhexedrine identified in Sec. 341.20(b)(1) or
(b)(9) when used in an inhalant dosage form. (A) ``This inhaler is
effective for a minimum of 3 months after first use.''
(B) ``Keep inhaler tightly closed.''
[59 FR 43409, Aug. 23, 1994, as amended at 63 FR 40650, July 30, 1998;
64 FR 13295, Mar. 17, 1999; 65 FR 8, Jan. 3, 2000]
[[Page 251]]
Sec. 341.90 Professional labeling.
The labeling of the product provided to health professionals (but
not to the general public) may contain the following additional dosage
information for products containing the active ingredients identified
below:
(a) For products containing ephedrine, ephedrine hydrochloride,
ephedrine sulfate, or racephedrine hydrochloride identified in
Sec. 341.16 (a), (b), (c), and (f). Children 6 to under 12 years of age:
oral dosage is 6.25 to 12.5 milligrams every 4 hours, not to exceed 75
milligrams in 24 hours. Children 2 to under 6 years of age: oral dosage
is 0.3 to 0.5 milligram per kilogram of body weight every 4 hours, not
to exceed 2 milligrams per kilogram of body weight in 24 hours.
(b) For products containing chlophedianol hydrochloride identified
in 341.14(a)(1). Children 2 to under 6 years of age: oral dosage is 12.5
milligrams every 6 to 8 hours, not to exceed 50 milligrams in 24 hours.
(c) For products containing codeine ingredients identified in
Sec. 341.14(a)(2). (1) Children 2 to under 6 years of age: Oral dosage
is 1 milligram per kilogram body weight per day administered in four
equal divided doses. The average body weight for each age may also be
used to determine dosage as follows: For children 2 years of age
(average body weight, 12 kilograms), the oral dosage is 3 milligrams
every 4 to 6 hours, not to exceed 12 milligrams in 24 hours; for
children 3 years of age (average body weight, 14 kilograms), the oral
dosage is 3.5 milligrams every 4 to 6 hours, not to exceed 14 milligrams
in 24 hours; for children 4 years of age (average body weight, 16
kilograms), the oral dosage is 4 milligrams every 4 to 6 hours, not to
exceed 16 milligrams in 24 hours: for children 5 years of age (average
body weight, 18 kilograms), the oral dosage is 4.5 milligrams every 4 to
6 hours, not to exceed 18 milligrams in 24 hours. The manufacturer must
relate these dosages for its specific product dosages for its specific
product to the use of the calibrated measuring device discussed in
paragraph (c)(3) of this section. If age is used to determine the dose,
the directions must include instructions to reduce the dose for low-
weight children.
(2) Parents should be instructed to obtain and use a calibrated
measuring device for administering the drug to the child, to use extreme
care in measuring the dosage, and not exceed the recommended daily
dosage.
(3) A dispensing device (such as a dropper calibrated for age or
weight) should be dispensed along with the product when it is intended
for use in children 2 to under 6 years of age to prevent possible
overdose due to improper measuring of the dose.
(4) Codeine is not recommended for use in children under 2 years of
age. Children under 2 years may be more susceptible to the respiratory
depressant effects of codeine, including respiratory arrest, coma, and
death.
(d) The following labeling indication may be used for products
containing guaifenesin identified in Sec. 341.18 when used as a single
ingredient product. ``Helps loosen phlegm and thin bronchial secretions
in patients with stable chronic bronchitis.''
(e) For products containing brompheniramine maleate identified in
Sec. 341.12(a). Children 2 to under 6 years of age: oral dosage is 1
milligram every 4 to 6 hours, not to exceed 6 milligrams in 24 hours.
(f) For products containing chlorcyclizine hydrochloride identified
in Sec. 341.12(b). Children 6 to under 12 years of age: oral dosage is
12.5 milligrams every 6 to 8 hours, not to exceed 37.5 milligrams in 24
hours. Children 2 to under 6 years of age: oral dosage is 6.25
milligrams every 6 to 8 hours, not to exceed 18.75 milligrams in 24
hours.
(g) For products containing chlorpheniramine maleate identified in
Sec. 341.12(c). Children 2 to under 6 years of age: oral dosage is 1
milligram every 4 to 6 hours, not to exceed 6 milligrams in 24 hours.
(h) For products containing dexbrompheniramine maleate identified in
Sec. 341.12(d). Children 2 to under 6 years of age: oral dosage is 0.5
milligram every 4 to 6 hours, not to exceed 3 milligrams in 24 hours.
(i) For products containing dexchlorpheniramine maleate identified
in Sec. 341.12(e). Children 2 to under 6 years: oral dosage is 0.5
milligram every 4 to 6 hours, not to exceed 3 milligrams in 24 hours.
[[Page 252]]
(j) For products containing diphenhydramine citrate identified in
Sec. 341.12(f). Children 2 to under 6 years of age: oral dosage is 9.5
milligrams every 4 to 6 hours, not to exceed 57 milligrams in 24 hours.
(k) For products containing diphenhydramine hydrochloride identified
in Sec. 341.12(g). Children 2 to under 6 years of age: oral dosage is
6.25 milligrams every 4 to 6 hours, not to exceed 37.5 mg in 24 hours.
(l) For products containing doxylamine succinate identified in
Sec. 341.12(h). Children 2 to under 6 years of age: oral dosage is 1.9
to 3.125 milligrams every 4 to 6 hours, not to exceed 18.75 milligrams
in 24 hours.
(m) For products containing phenindamine tartrate identified in
Sec. 341.12(i). Children 2 to under 6 years of age: oral dosage is 6.25
milligrams every 4 to 6 hours, not to exceed 37.5 milligrams in 24
hours.
(n) For products containing pheniramine maleate identified in
Sec. 341.12(j). Children 2 to under 6 years of age: oral dosage is 3.125
to 6.25 milligrams every 4 to 6 hours, not to exceed 37.5 milligrams in
24 hours.
(o) For products containing pyrilamine maleate identified in
Sec. 341.12(k). Children 2 to under 6 years of age: oral dosage is 6.25
to 12.5 milligrams every 6 to 8 hours, not to exceed 50 milligrams in 24
hours.
(p) For products containing thonzylamine hydrochloride identified in
Sec. 341.12(l). Children 2 to under 6 years of age: oral dosage is 12.5
to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24
hours.
(q) For products containing triprolidine hydrochloride identified in
Sec. 341.12(m). Children 4 to under 6 years of age: oral dosage is 0.938
milligram every 4 to 6 hours, not to exceed 3.744 milligrams in 24
hours. Children 2 to under 4 years of age: oral dosage is 0.625
milligram every 4 to 6 hours, not to exceed 2.5 milligrams in 24 hours.
Infants 4 months to under 2 years of age: oral dosage is 0.313 milligram
every 4 to 6 hours, not to exceed 1.252 milligrams in 24 hours.
(r) For products containing diphenhydramine citrate identified in
Sec. 341.14(a)(5). Children 2 to under 6 years of age: oral dosage is
9.5 milligrams every 4 hours, not to exceed 57 milligrams in 24 hours.
(s) For products containing diphenhydramine hydrochloride identified
in Sec. 341.14(a)(6). Children 2 to under 6 years of age: oral dosage is
6.25 milligrams every 4 hours, not to exceed 37.5 milligrams in 24
hours.
[51 FR 35339, Oct. 2, 1986, as amended at 52 FR 30057, Aug. 12, 1987; 54
FR 8509, Feb. 28, 1989; 57 FR 58376, Dec. 9, 1992; 59 FR 4218, Jan. 28,
1994; 59 FR 29174, June 3, 1994; 59 FR 36051, July 15, 1994]