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Doxylamine succinate

This article was originally published in The Tan Sheet

Executive Summary

September 1994 issue of FDA Consumer outlines the regulatory history of the nighttime sleep-aid. The article was written at the recommendation of FDA's Nonprescription Drugs Advisory Committee at a July 1993 meeting to inform consumers of the tumorigenicity potential of the antihistamine/sleep-aid in rodents. The advisory committee suggested the article in lieu of requiring a label warning ("The Tan Sheet" July 5, 1993, p. 5). FDA's Pulmonary-Allergy Drugs Advisory Committee earlier recommended a warning label. The article notes that FDA conducted a tumorigenicity study in rats and mice that was inconclusive
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