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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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Consumer Healthcare Products Association filings
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Activity

Consumer Healthcare Products Association filed 1 comment on this docket between Nov 12, 2025 and Nov 12, 2025. 17 other organizations filed here.

What Consumer Healthcare Products Association filed (1)

Nov 12, 2025· Comment from Consumer Healthcare Products Association (CHPA)· FDA-2025-P-4153-0268

Comment from the Consumer Healthcare Products Association (CHPA) Please see attached file

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Abstract

No abstract recorded.

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Co-filers (17)

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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. (FDA) — Consumer Healthcare Products Association | OpenPolis