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Advil label changes

This article was originally published in The Tan Sheet

Executive Summary

Labeling for Advil Cold & Sinus tablets and liqui-gels will now carry the warning, "Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin," according to an updated version of FDA's MedWatch website. An ad campaign by aspirin manufacturer Bayer in 2003 pointed to studies showing that ibuprofen may interfere with the benefits of low-dose aspirin (1"The Tan Sheet" Nov. 17, 2003, p. 5). Modifications also are being made to several of Wyeth's children's products to include allergy warnings. The "Allergy Alert" portion of the Drug Facts Panel "has been revised to include a warning for aspirin sensitive individuals and a description of early symptoms associated with Stevens-Johnson Syndrome (SJS)" for Children's Advil Cold, Children's Advil Allergy Sinus, Children's Advil Chewables and Infant's Advil, the MedWatch website notes...
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