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Diphenhydramine dual antitussive/antihistamine indication approved in final rule.

This article was originally published in The Tan Sheet

Executive Summary

DIPHENHYDRAMINE DUAL INDICATION PERMITTED BY FDA pending the completion of the OTC cough/cold combination drug products final monograph. Under a final rule published by FDA in the April 9 Federal Register, effective immediately, OTC products containing either diphenhydramine citrate or diphenhydramine HCl can be labeled as both an antitussive and an antihistamine in single-ingredient and cough/cold combination products.
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