Acetaminophen

Browse Acetaminophen Content

Submission

CHPA appreciates the opportunity to provide comments to the FDA in response to “Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen”. CHPA and its member companies have an interest and expertise in acetaminophen-containing OTC products and support FDA’s efforts to improve the safe use of acetaminophen.

Dec 8, 2014

Submission

CHPA requests that FDA publish a statement of enforcement policy expressly permitting manufacturers of single-ingredient acetaminophen OTC drugs subject to the ongoing internal analgesic, antipyretic, and antirheumatic monograph proceedings to including labeling on products that provide instructions for use in children aged six months to two years.

Aug 15, 2013

Submission

CHPA supports advancing modernization of USP's quality monographs, updating and improving the compendial test methods and establishing product standards which can provide an additional measure of safety for OTC products.

Jul 31, 2013

Submission

Enclosed are comments on "Guidance for Industry; Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use - Labeling for Products that Contain Acetaminophen."

Sep 4, 2012

Submission

CHPA recognizes the need for modernization of USP monographs. CHPA member companies are dedicated to fulfilling their commitment outlined in the letter to this Planning Committee on February 2, 2011.

Jul 11, 2011

Submission

CHPA strongly supports the unanimous votes by the advisory committees to add weight-based dosing directions to the existing age-based labeled dosing directions for children.

Jun 27, 2011

Submission

CHPA's Internal Analgesics task group seeks the agency's clarification of three provisions of the final rule.

Aug 26, 2009

Submission

Briefing book for the Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee, June 29-30, 2009.

Jun 29, 2009

Filter Results