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Acetaminophen warnings

This article was originally published in The Tan Sheet

Executive Summary

Current labeling of OTC acetaminophen products is adequate and an additional general allergy warning or one concerning cross-reactivity for aspirin-sensitive patients is not warranted, McNeil Consumer Healthcare states in comments to FDA. The comments are in response to a June 9 submission filed by Whitehall-Robins (marketer of the ibuprofen analgesic Advil) arguing acetaminophen has allergenic potential and should be required to carry warnings (1"The Tan Sheet" July 5, In Brief). In its response, McNeil cites four new studies and a chart showing a lower incidence of allergic adverse events related to acetaminophen use than with ibuprofen, naproxen sodium and other ingredients

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