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Phenol as OTC antitussive

Executive Summary

Results of five clinical studies to support adding phenol to the antitussive final monograph, published in August 1988, have been submitted by Rich-Vicks to FDA. Phenol is the active ingredient in the company's Chloraseptic. The ingredient is a Category I anesthetic/analgesic, but is not included in the antitussive monograph. The petition maintains that although no data had been submitted, Chloraseptic has been labeled for "smokers cough" dating back to the 1960s.

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