OTC Medicines

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The PCPC and CHPA are pleased to provide these comments in response to FDA's proposed amendment to the final monograph for OTC sunscreen drug products for human use.

Feb 26, 2007

This meta-analysis aimed to compare single-dose 10 mg phenylephrine and placebo separately in adult patients with acute nasal congestion due to the common cold.

Feb 1, 2007

This summary report presents the key findings of a national survey of American adults regarding the use of over-the-counter cough remedies to alleviate cough symptoms resulting from the flu, a cold, or other respiratory ailment.

Jan 26, 2007

Request for extension of comment period regarding Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs.

Oct 12, 2006

Letter to the FDA's LT Darrell Lyons requesting additional time to address the Nonprescription Drugs Advisory Committee.

Sep 11, 2006

While DXM is used safely by millions of Americans, some teenagers and young adults are intentionally abusing large quantities of medicines containing DXM in an effort to get high.

Jul 26, 2006

CHPA appreciates the comments of FDA in the February 2006, feedback letter and understands that these comments are FDA’s best advice on designing a protocol to address the safety and efficacy of benzocaine. We have included a revised final protocol for your final review.

Jun 5, 2006

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