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In Brief: Diphenhydramine

This article was originally published in The Tan Sheet

Executive Summary

Diphenhydramine: Warner-Lambert urges FDA in May 9 comments to allow OTC marketing of diphenhydramine hydrochloride as a single ingredient with labeling for both antihistamine and antitussive use beginning June 5. The agency proposed in a Feb. 23 amendment to the cough/cold combination TFM to allow single-ingredient products with both indications. However, the agency has not announced whether marketing could begin prior to publication of the cough/cold combination final monograph. P&G submitted a similar request on May 9 ("The Tan Sheet" May 22, p. 8)...
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