FDA endorses industry iniative to update children's cough-cold product labeling

ROCKVILLE, Md The Food and Drug Administration on Wednesday issued a consumer update regarding the use of cough/cold products in children that reinforces the agency’s support of an industry initiative that changes label recommendations on pediatric cough/cold products to no longer recommend use in children under the age of four, and explains the reasoning behind why the agency hasn’t requested an immediate product recall of current labeling.

“The voluntary actions announced by the Consumer Healthcare Products Association are intended to help prevent and reduce the misuse of these products in children and to better inform consumers about their safe and effective use,” the agency stated. “CHPA's voluntary actions will not affect the availability of the medicines, but will result in a transition period where the instructions for using some OTC cough and cold medicines in children will be different from others. Some product instructions will state ‘do not use’ in children under 4 years of age, while others will instruct not to use in children under 2 years of age. FDA does not typically request that OTC products with previous labeling be removed from the shelves during a voluntary label change such as this one. The agency recommends following the dosage instructions and warnings on the label that accompanies the medication if you have or buy a product that does not have the voluntarily modified labeling.”

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