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FDA Warns on Tots' Cough, Cold Drug Use

FDA: Don’t Give Cough or Cold Medicines to Kids Under 2 Unless Told to Do So By a Health Care Provider

Industry Responds

WebMD contacted the Consumer Healthcare Products Association (CHPA), a trade group representing U.S. makers and distributors of over-the-counter (OTC) medicines and nutritional supplement products, for its response to the FDA's public health advisory.

The CHPA replied with an emailed statement from Linda Suydam, DPA, CHPA president.

In the statement, Suydam says: “Millions of Americans safely and effectively use OTC cough and cold medicines every year, both for themselves and for their families. These medicines have been found safe and effective by the U.S. Food and Drug Administration (FDA) and are the same medications families have trusted for decades to help relieve cough and cold symptoms and make their children feel better.

“Parents know they can rely on safe and effective OTC cough and cold remedies when treating their children, but must do so according to label directions. As with all medicines, not following the label can result in harm to children. We know that adverse events can be the result of parents giving too much medicine to their children. OTC cough and cold medicine labels contain detailed information to help parents correctly medicate their children, including an instruction to contact a physician before giving the medication to a child under the age of two.

“We commend FDA on its commitment to ensuring American parents have quality medicines and the information to use them correctly when caring for children. We look forward to working closely with the agency and the healthcare community on this very important issue and at FDA’s October meeting of its expert advisory committee.“

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