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OTC pediatric analgesic directions for infant dosing recommended by NDAC.

This article was originally published in The Tan Sheet

Executive Summary

OTC PEDIATRIC ANALGESIC/ANTIPYRETIC LABELING FOR CHILDREN UNDER TWO YEARS recommended by FDA's Nonprescription Drugs Advisory Committee at its Sept. 18 meeting in Gaithersburg, Md. Members of the Arthritis Advisory Committee also attended. The committee met to discuss labeling directions for two product formulations: suspension liquid, which is labeled for use by children ages two to 11, and concentrated infant drops, labeled for use by children two and three years old. The meeting marked the second consideration by the advisory committee of issues relating to the proper dosing of pediatric medications. The first occurred in early 1995 ("The Tan Sheet" Jan. 16, 1995, p. 10).

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