Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Reopening of the Administrative Record for Antihistamine Drug Products

Zusammenfassung

The Food and Drug Administration (FDA) is reopening the administrative record for over-the-counter (OTC) antihistamine drug products to accept comments on recommendations concerning the use of these products to relieve symptoms of sneezing and runny nose associated with the common cold made at a joint advisory committee meeting on November 16, 1995. The agency is inviting comments on its tentative position that there is sufficient basis to include the use of OTC antihistamines for these symptoms in the final monograph for OTC cold, cough, allergy, bronchodilator, and antiasthmatic drug products. This reopening is part of the ongoing review of OTC drug products conducted by FDA.