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Consumer OTC Drugs

OTC diphenhydramine may carry both antihistamine and antitussive claims.

This article was originally published in The Tan Sheet

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Executive Summary

OTC DIPHENHYDRAMINE MAY BE INDICATED AS BOTH ANTITUSSIVE AND ANTIHISTAMINE in single-ingredient products and in cough/cold combination products under a proposed amendment to the OTC cold, cough, allergy, bronchodilator and anti-asthmatic combination products tentative final monograph published in the Feb. 23 Federal Register. The amendment also allows for the marketing of both diphenhydramine HCl and diphenhydramine citrate as antitussive ingredients in certain combination cough/cold products.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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