Requests that FDA, under FDCA §505G(b) (OTC monograph administrative order process), amend OTC Monograph M013 to update Drug Facts labeling for all over-the-counter acetaminophen-containing products. In the alternative, Petitioner asks FDA to initiate such an order on its own

11 organizations filed 11 public comments on Requests that FDA, under FDCA §505G(b) (OTC monograph administrative order process), amend OTC Monograph M013 to update Drug Facts labeling for all over-the-counter acetaminophen-containing products. In the alternative, Petitioner asks FDA to initiate such an order on its own, at the Food and Drug Administration.

Abstract

Open

Commenters (11)

• Consumer Healthcare Products Associationtrade assoc.

  1 filing · confidence 97%
• Kenvue Brands LLCunverified attribution

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

  1 filing · confidence 70%
• Kenvue Brands LLC part 2 of 4unverified attribution

  1 filing · confidence 70%
• Kenvue Brands LLC part 3 of 4unverified attribution

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

  1 filing · confidence 70%
• Supplemental Comment from Kenvue Brands LLC part 6 of 9unverified attribution

  1 filing · confidence 70%
• Supplemental Comment from Kenvue Brands LLC part 7 of 9unverified attribution

  1 filing · confidence 70%
• Supplemental Comment from Kenvue Brands LLC part 8 of 9unverified attribution

  1 filing · confidence 70%
• Supplemental Comment from Kenvue Brands LLC part 9 of 9unverified attribution

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

  1 filing · confidence 85%