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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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American Academy of Pediatrics (AAP) filings
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American Academy of Pediatrics (AAP) filed 1 comment on this docket between Nov 12, 2025 and Nov 12, 2025. 17 other organizations filed here.

What American Academy of Pediatrics (AAP) filed (1)

Nov 12, 2025· Comment from American Academy of Pediatrics· FDA-2025-P-4153-0252

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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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) — American Academy of Pediatrics (AAP) | OpenPolis