News 10/05/1992
P92-28 Food and Drug Administration
FOR IMMEDIATE RELEASE Mike Shaffer - (301) 443-3285
The Food and Drug Administration today reminded parents and child care
providers to carefully follow label instructions when giving nonprescription
medications to children.
"Children are not small adults," FDA Commissioner David A. Kessler,
M.D., said. President Bush has proclaimed Oct. 5 as National Child Health
Day.
"If you take a dose meant for an adult and simply reduce it for a child,
you may be giving that child more than is needed -- or not enough," Dr.
Kessler said. "Some parents think they can double the dose if their child
seems twice as sick. That's incorrect and dangerous."
Approximately 40 percent of U.S. consumers use nonprescription medicines
to treat illnesses in the home. Most treatments are for colds and
cold-related symptoms that occur most frequently in the fall and winter.
To reach consumers and health professionals, FDA is also sending letters
and background information to health reporters and the medical press;
publishing a brochure that will be available through the Consumer
Information Center in Pueblo, Colo.; and planning to discuss the issue in a
forthcoming edition of the agency's Medical Bulletin that is mailed to
physicians throughout the country.
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Page 2, P92-28, Children/OTC Drugs
The statement and recommendations by the agency on proper and safe use
of nonprescription drugs were prompted in part by the inadvertant overdosing
of children when parents either misread medicine dose cup markings or did
not follow directions properly. (See Press Release 92-1, Jan. 21, 1992.)
FDA, industry and consumer groups have ongoing programs to encourage
consumers and patients to follow instructions carefully and adhere to
cautions and warnings on nonprescription and prescription medicines.
Recommendations include the following:
-- Use child-resistant caps to prevent accidents, and do not leave caps
off containers.
-- Store medicines as instructed and in a safe place out of reach of
children.
-- Don't give medicine to children unless it is recommended for them on
the label or by a physician.
-- Don't use medicine for purposes that are not called for on the label.
-- Don't try to remember the dose used during previous illnesses; read
the label each time.
-- Don't guess when converting measuring units -- for example from
teaspoons (TSP) or tablespoons (TBS) to ounces. Check with a reliable
source, such as a pharmacist.
-- Examine dose cups carefully. Cups may be marked with various units
of measurement, including TSP, TBS, OZs, drams, and others and may not use
standard abbreviations. Be sure to follow the instructions on the label.
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Page 3, P92-28, Children/OTC drugs
-- Check with a doctor before giving a child more than one product at a
time.
-- Check with a doctor before treating a child with aspirin products.
Aspirin should not be used for childhood flu or chickenpox.
FDA's educational program is being carried out jointly with other Public
Health Service agencies and the Nonprescription Drug Manufacturers
Association. For a free copy of the brochure on treating children with
over-the-counter medications, write to: Child Health, Pueblo, Colo. 81009.
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