FDA to Consider Permitting Dosage Information on OTC Children’s Fever/Pain Remedy Products

The Consumer Healthcare Products Association (“CHPA”) has petitioned the FDA to allow dosing information to be provided on fever/pain relief drug labels. The CHPA is a trade group representing OTC manufacturers of acetaminophen products. Any parent with young children knows that OTC fever/pain relief products currently do not contain dosing information for children under two years of age. Although parents may have obtained the proper dosing instructions from their child’s pediatrician, recalling and/or finding that information (especially in the middle of the night) can be difficult. CHPA is pushing the FDA to approve dosing instructions for children between six months and 23 months. According to CHPA, that age range is when most acetaminophen usage in children occurs. 

Should the FDA approve the new labeling, manufacturers of children’s fever/pain remedy products will need to work with appropriate medical professionals and scientists, as well as counsel, to ensure dosing instructions are in accordance with accepted standards.

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