Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Combination Bronchodilator Drug Products Containing Theophylline

Résumé

The Food and Drug Administration (FDA) is issuing a final rule establishing that cough-cold combination drug products containing theophylline are not generally recognized as safe and effective and are misbranded for over-the-counter (OTC) use. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued in the form of a tentative final monograph, and all new data and information on OTC cough-cold combination drug products containing theophylline that have come to the agency's attention. Also, this final rule lists in a regulation all OTC bronchodilator ingredients that have been found to be not generally recognized as safe and effective and are misbranded. This final rule is part of the ongoing review of OTC drug products conducted by FDA.