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Consumer OTC Drugs

In Brief: JB Williams

This article was originally published in The Tan Sheet

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Executive Summary

JB Williams: Submits "belated" comments to FDA regarding the January 1988 tentative final monograph for OTC oral health care products on April 18. The company, which sells Cepacol Maximum Strength Sore Throat Spray, is requesting that the agency "amend the directions for dosage forms" to allow "continued use of directions similar to or the same as those already in use for marketed OTC anesthetic/analgesic sprays." Directions for use in the TFM would instruct consumers to "gargle, swish around or allow to remain in place for at least one minute and then spit out" a liquid anesthetic/analgesic, which the company points out is inappropriate for sprays...

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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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