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.
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.
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.
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.
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.
The objectives of this study are: To evaluate the efficacy and safety of 10% and 20% benzocaine gel for the relief of toothache, compared to placebo and to each other; and to assess the subject’s compliance with the dosing directions on the proposed label.
