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.

18 organizations filed 18 public comments on 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., at the Food and Drug Administration.

Commenters (18)

• Alliance for Women's Health & Preventiontrade assoc.

  1 filing · confidence 85%
• American Academy of Pediatrics (AAP)

  1 filing · confidence 97%
• American Pharmacists Association (APhA)trade assoc.

  1 filing · confidence 97%
• Autism Science Foundationtrade assoc.

  1 filing · confidence 85%
• Consumer Healthcare Products Associationtrade assoc.

  1 filing · confidence 97%
• Kenvue Brands LLC part 1 of 7unverified attribution

  1 filing · confidence 70%
• Kenvue Brands LLC part 2 of 7unverified attribution

  1 filing · confidence 70%
• Kenvue Brands LLC part 3 of 7unverified attribution

  1 filing · confidence 70%
• Kenvue Brands LLC part 4 of 7unverified attribution

  1 filing · confidence 70%
• Kenvue Brands LLC part 5 of 7unverified attribution

  1 filing · confidence 70%
• Kenvue Brands LLC part 6 of 7unverified attribution

  1 filing · confidence 70%
• Kenvue Brands LLC part 7 of 7unverified attribution

  1 filing · confidence 70%
• National Consumers Leaguetrade assoc.

  1 filing · confidence 85%
• Society for Developmental and Behavioral Pediatricstrade assoc.

  1 filing · confidence 85%
• Society for Maternal-Fetal Medicinetrade assoc.

  1 filing · confidence 85%
• Supplemental Comment from Kenvue Brands LLCunverified attribution

  1 filing · confidence 70%
• The Protecting Access to Pain Relief (PAPR) Coalitiontrade assoc.

  1 filing · confidence 85%
• Unbiased Science LLCunverified attribution

  1 filing · confidence 70%