FDA warns about cold medicines for babies

updated 9:14 a.m. ET Aug. 16, 2007

WASHINGTON - The government is warning parents not to give cough and cold medicines to children under 2 without a doctor’s order, part of an overall review of the products’ safety and effectiveness for youngsters.

Amid questions about benefits and risks, the Food and Drug Administration said Wednesday its Nonprescription Drugs Advisory Committee will meet Oct. 18-19 to discuss the use of cough and cold drugs by children.

The FDA issued a public health advisory that cited serious adverse effects linked to children — particularly those 2 and younger — who have received too great a dose of over-the-counter medications for coughs and colds.

Parents should carefully follow directions for use that come with a medication, the FDA said. Other recommendations in the advisory included:

• Do not use cough and cold products in children under 2 unless given specific directions to do so by a health care provider.
• Do not give children medicine that is packaged and made for adults. Use only products marked for use in babies, infants or children, sometimes called “pediatric” use.
• Cough and cold medicines come in different strengths. If unsure about the right product for a child, ask a health care provider.
• If other medicines, whether over-the-counter or prescription, are being given to a child, the child’s health care provider should review and approve their combined use.
• Read all of the information in the “Drug Facts” box on the package label to know the active ingredients and the warnings.
• For liquid products, parents should use the measuring device that is packaged with each medicine formulation and is marked to deliver the recommended dose. A kitchen teaspoon or tablespoon is not an appropriate measuring device.

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