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Cough & Cold Medicine Advisory & Tips for Parents
by U.S. Food & Drug Administration
August 15, 2007 - FDA announced today that, in October, the Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of cough and cold drug product use in children. Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under 2 years of age. In preparation for the meeting, FDA is reviewing safety and efficacy data for the ingredients of these products.
Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used. To avoid giving a child too much medicine, parents must carefully follow the directions for use of the product in the “Drug Facts” box on the package label.
What should parents know about using cough and cold products in children?
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