Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph for OTC Antihistamine Drug Products

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The Food and Drug Administration (FDA) is amending the final monograph for over-the-counter (OTC) antihistamine drug products to include the ingredient doxylamine succinate. FDA is issuing this final rule after considering extensive information concerning this ingredient and the recommendations of its Nonprescription Drugs Advisory Committee (NDAC), which met on June 28, 1993, to consider potential labeling for doxylamine succinate regarding the results of toxicology testing conducted under the National Toxicology Program (NTP). This final rule is part of the ongoing review of OTC drug products conducted by FDA.