Acetaminophen

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

Aug 26, 2009

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

CHPA comments on the proposed rule, which proposes new warning and other labeling requirements for internal analgesic, antipyretic, and antirheumatic OTC drug products.

May 25, 2007

CHPA appreciates the opportunity to provide comments to the FDA in response to the draft guidance for industry “Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions”.

Jan 27, 2005

FDA Announcement of a proposed safety-based Administrative Order that proposes to add a skin allergy warning to labeling requirements for acetaminophen-containing drug products.

FDA Announcement of a proposed safety-based Administrative Order (AO) to address dosage strengths of oral, single ingredient, pediatric acetaminophen products. This AO proposal includes the addition of weight and age-based dosing for children under age 12.

Understand how CHPA’s member companies are working to replenish supply quickly by directing products where they are needed most. This document also includes information about where parents can find these medicines and additional self-care options to aid in comfort and relief.

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