Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph, and Related Labeling; Reopening of Comment Period

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The Food and Drug Administration (FDA) is reopening until September 2, 2003, the comment period on the agency's proposal to amend the tentative final monograph (TFM) for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include ibuprofen as a generally recognized safe and effective analgesic/antipyretic active ingredient for OTC use and to amend its regulations to include consistent allergy warnings for OTC IAAA drug products containing nonsteroidal antiinflammatory active ingredients. The proposal was published in the Federal Register of August 21, 2002 (67 FR 54139). FDA is taking this action in response to a request for an extension of 90 days for the submission of comments on the proposed rule. The comment period for this information closed on November 19, 2002.