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OTC analgesic 65 mg caffeine limit "not supported" by the record, Bristol-Myers tells FDA.

This article was originally published in The Tan Sheet

Executive Summary

ANALGESIC 65 MG CAFFEINE LIMIT "NOT SUPPORTED," BRISTOL-MYERS SQUIBB ASSERTS in a May 1 letter to FDA. Responding to an April 18 FDA feedback letter, the manufacturer of Bufferin, Excedrin and Nuprin said that the "conclusion that caffeine cannot be considered generally recognized as safe (GRAS) at doses in excess of 65 mg is not supported by the record." FDA told Bristol that the upcoming final monograph on OTC internal analgesic/antipyretic drug products will set a limit of 64 or 65 mg caffeine per dose of those products ("The Tan Sheet" May 8, pp. 1-4).
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