Requests that the FDA amend the applicable OTC monograph for internal analgesic, antipyretic, and antirheumatic drug products (OTC Monograph M013). Petitioner requests that FDA require all OTC acetaminophen-containing drug products labeled for use in infants and children to include an additional warning and caregiver-directed instruction
🏛 Food and Drug Administration (FDA)FDA-2026-P-5976
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