News
05/11/1987

<TITLE>OTC Drugs For Motion Sickness </TITLE>
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OTC Drugs For Motion Sickness 

P87-13                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                          Edward Nida  - (301) 443-3285


     The Food and Drug Administration has concluded that the major
nonprescription motion sickness drugs on the market today are effective in
preventing and treating motion-induced nausea and vomiting. 
     The agency declared the effectiveness of four active ingredients used in 
the motion sickness drugs in a final rule for this class of drug.  The rule 
establishes what ingredients can be used for nonprescription motion sickness
drugs and what warnings must be stated in the labeling.  This final rule is 
part of FDA's ongoing review of all nonprescription drug product ingredients, 
which was begun in 1972.
     FDA concludes that four active ingredients -- cyclizine hydrochloride, 
dimenhydrinate, diphenhydramine hydrochloride and meclizine hydrochloride --
are safe and effective for preventing and treating nausea, vomiting and 
dizziness associated with motion sickness.  Products that contain these 
ingredients include Marezine (cyclizine hydrochloride), Dramamine 
(dimendhydrinate) and Bonine (meclizine hydrochloride). 
     Diphenhydramine hydrochloride is the active ingredient in Benadryl but 
that product is not currently labeled for motion sickness, though it is often 
prescribed by doctor's for that use.  Today's action will permit the
nonprescription drug to be labeled for motion sickness. 
     The four ingredients are antihistamines which are thought to work by 
blocking signals from the inner ear to the vomiting center.  Twelve months
after publication of the final rule on motion sickness drugs (in the Federal
Register) only these four active ingredients will be permitted in 
nonprescription motion sickness products.  FDA is requiring that the labels 
warn that any of these antihistamine ingredients may cause drowsiness,
especially if combined with alcohol, sedatives or tranquilizers.
     The warning must include, in addition, these specific admonitions: 
     "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."  A further warning, "Do not give to children under 2 years of age 
unless directed by a doctor," will be required on products containing 
dimenhydrinate, while no use "under 6" is advised for diphenhydramine 
hydrochloride.
     Products containing one of the four drug ingredients must also warn, "Do 
not take this product if you have asthma, glaucoma, emphysema, chronic
pulmonary disease, shortness of breath, difficulty in breathing, or difficulty
in urination due to enlargement of the prostate gland unless directed by a
doctor."
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