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Citizen Petition On Phenylephrine Requests Pulling OTC Status For Children

This article was originally published in The Tan Sheet

Executive Summary

A citizen petition asks FDA to withdraw OTC approval for phenylephrine use by children under 12 years old and to raise the maximum dose to 25 mg, but also recommends more research to determine the most effective dosage level

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Nonprescription Drugs Advisory Committee will meet online 11-12 September to consider data regarding generally recognized as safe and effective status for oral phenylephrine as a nasal decongestant which have become available since FDA last examined ingredient.

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NDAC will discuss whether data supports oral phenylephrine’s GRASE as nasal decongestant. Potential for removing phenylephrine from monograph could be linked to restricting nonprescription pseudoephedrine drugs to behind-the-counter sales since 2006 and overhaul of FDA monograph program authorized in 2020.

Petition Answers FDA Questions On Oral Phenylephrine Efficacy, Suggests Removal From Monograph

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