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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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National Consumers League filings
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National Consumers League filed 1 comment on this docket between Nov 6, 2025 and Nov 6, 2025. 17 other organizations filed here.

What National Consumers League filed (1)

Nov 6, 2025· Comment from National Consumers League· FDA-2025-P-4153-0161

Filed on regulations.gov — full text not in the inline record.

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Abstract

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Co-filers (17)

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