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Cold, Flu, & Cough Health Center

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Cough, Cold Drugs Not for Kids Under 4

Voluntary Label Change Says Don't Give Over-the-Counter Pediatric Cough and Cold Medicine to Children Younger Than 4
WebMD Health News
Reviewed by Louise Chang, MD

Oct. 7, 2008 -- Don't use over-the-counter pediatric cough and cold drugs in kids younger than 4.

Leading makers of over-the-counter pediatric cough and cold drugs are putting that message on the products' labels, according to the Consumer Healthcare Products Association (CHPA), a trade group for makers of over-the counter drugs.

The label change comes after consulting with the FDA, which has been reviewing the safety of over-the-counter pediatric cough and cold drugs. But the FDA didn't order the label change; drugmakers did that voluntarily.

"We support this voluntary action that's been taken by the industry," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said today at a news conference. “Parents should follow, very carefully, the directions on the package” and not give children multiple products at the same time, says Woodcock.

Nonprescription pediatric cough and cold medicines are covered by rules that date back 30 to 40 years, and modern studies of the drugs – including clinical trials in children -- are needed, notes Woodock, adding that that process may take several years.

The issue isn't an ingredient in the drugs, but dosing errors, notes the CHPA. Pediatric cough and cold drugs are "safe and effective when used as directed," says the CHPA, adding that dosing errors and accidental ingestions are "the leading causes of rare adverse events in young children."

About 7,000 children under 11 go to emergency rooms each year after taking cough and cold medicines, according to the CDC. Roughly two-thirds of those occurred after children drank medication while unsupervised, according to the CDC.

The goal of the label change is to encourage "the appropriate use of these medicines," says the CHPA.

The new labels will start showing up on store shelves this year. The CHPA says there are no plans to take products with the old labels off the shelves since the FDA hasn't indicated a need to do so.

In January, the FDA urged parents and caregivers not to give over-the-counter cough and cold drugs to kids younger than 2. Drugmakers voluntarily took over-the-counter infant cough and cold drugs off the market in October 2007.

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