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FDANonrulemakingFDA-2025-P-4153

Requests that the FDA require revisions to the labeling for all over-the-counter acetaminophen-containing drug products marketed under the Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use monograph (OTC Monograph M013): (i) a revision to the “Warnings” subsection, currently found at M013.50(c)(1)(iii) in the Labeling section.

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Jan 2, 2026
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American Pharmacists Association (APhA) filings
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American Pharmacists Association (APhA) filed 1 comment on this docket between Jul 21, 2026 and Jul 21, 2026. 17 other organizations filed here.

What American Pharmacists Association (APhA) filed (1)

Jul 21, 2026· Comment from American Pharmacists Association· FDA-2025-P-4153-0319

Dear Dockets Management Staff, The American Pharmacists Association (APhA) appreciates the opportunity to provide FDA comments on the importance of maintaining the integrity of the Vaccine Injury Compensation Program (VICP) and the critical role that pharmacists and those under their supervision have in vaccinating patients nationwide. APhA represents pharmacists, student pharmacists, and pharmacy technicians in all practice settings, including but not limited to community pharmacies, hospitals, long-term care facilities, specialty pharmacies, community health centers, physician offices, ambulatory clinics, managed care organizations, hospice settings, and government facilities. Our members strive to improve medication use, advance patient care, and enhance public health. Full comments are attached.

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