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Consumer OTC Drugs

Analgesics alcohol warning to note possible liver, stomach problems under FDA proposal.

This article was originally published in The Tan Sheet

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Executive Summary

FDA ALCOHOL WARNING SPECIFYING POTENTIAL ORGAN HARM PROPOSED for all OTC analgesics intended for adult use. Published in the Nov. 14 Federal Register, the proposed rule includes three warning statements: one for acetaminophen products that cautions against liver damage; one for aspirin, related ingredients and nonsteroidal anti-inflammatory drugs that cautions against stomach bleeding; and one for products containing combinations of acetaminophen and other analgesic/antipyretic ingredients that cautions against liver damage and stomach bleeding.

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