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From the Food and Drug Administration
December 2, 1998

New Alcohol Warning Required for OTC Analgesic/Antipyretic Products

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JAMA. 1998;280(21):1817. doi:10.1001/jama.280.21.1817

The FDA has issued a final rule requiring alcohol warnings on over-the-counter (OTC) drug products for internal use containing analgesic/antipyretic ingredients (including acetaminophen and nonsteroidal anti-inflammatory analgesic/antipyretic ingredients [NSAIDs]) that advises people who consume three or more alcoholic drinks every day to consult their physicians before taking any of these products.

The rule is part of the agency's ongoing review of OTC drug products and has been made final after consideration of comments received on a previously published proposed rule, recommendations of three agency advisory committees, and new data and information. The new warnings, required to be in effect April 23, 1999, for all these OTC products, will begin as follows: "Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take [name of ingredient for which warning is required to be inserted] or other pain relievers/fever reducers."

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