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NSAID Labeling Revisions Revised By FDA; Compliance Date Extended

This article was originally published in The Tan Sheet

Executive Summary

FDA has deleted the part of its recommended heart risk warning for NSAIDs that discourages use for "longer than 10 days or more than the recommended dose.

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FDA proposes adding warnings on labeling for OTC pain relievers to advise consumers of "potential health risks" associated with acetaminophen and NSAIDs such as aspirin, ibuprofen and naproxen

FDA Proposes Liver, GI Risk Warnings For OTC Pain Relievers

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