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FDA Panel Narrowly Votes Against Cough/Cold Drugs For Children Up To Age 6

This article was originally published in The Tan Sheet

Executive Summary

An FDA advisory panel decided in split votes Oct. 19 to recommend immediately that all OTC cough/cold medicines should not be used for 2-to 5-year-old children but are safe for 6- to 12-year-olds

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Ambitious Schedule For OTC Monograph Updates On FDA Unified Agenda

Nearly two-thirds of FDA’s planned regulatory actions for the consumer health segment would update the OTC drug monograph, including changes to pediatric cough/cold labeling, acetaminophen dosing, oral care products with benzocaine and labeling for some laxatives.

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