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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

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

Personal Care Products Council and CHPA comments in response to FDA rule regarding labeling and effectiveness requirements for certain OTC sunscreen products.

Aug 16, 2011

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

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

Aug 26, 2009

CHPA and its member companies have an interest and expertise in label comprehension studies and support FDA's efforts to develop guidance for industry on this important topic.

Jul 30, 2009

CHPA and its member companies who make oral pediatric cough and cold medicines strongly believe that the current data support the safety and efficacy of these medicines when used as directed; however, we are committed to working with FDA to better enhance consumer use of these products.

Jul 10, 2008

These comments are submitted in response to the public meeting held June 5 and 6, 2008, on evaluating proposed proprietary names for drug products.

Jul 7, 2008

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