WASHINGTON, Oct. 11 (UPI) -- The makers of more than one dozen over-the-counter infant cough and cold medicines are voluntarily pulling the products from the U.S. market.
The withdrawal comes on the heels of reports by the U.S. Food and Drug Administration suggesting some of the medicines were associated with serious side effects and some deaths in patients younger than 6, The New York Times said Thursday.
The Consumer Healthcare Products Association, which represents over-the-counter drug makers, said the voluntary withdrawal affects only "infant" oral medicines, not those intended and labeled for use in children age 2 and older.
The brands include Dimetapp, Little Colds, Pediacare, Robitussin, Triaminic and Tylenol.
"It’s important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," CHPA president Linda A. Suydam said Thursday in a release.
The trade group is recommending that the FDA change labels on children’s cough and cold medicines from "ask a doctor" before using to "do not use" in children under 2.
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