title: Labeling for bronchodilators to treat asthma; cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. Final rule.
abstract: The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) bronchodilator drug products to add additional warnings (e.g., an "Asthma alert'') and to revise the indications, warnings, and directions in the labeling of products containing the ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine hydrochloride, and racepinephrine hydrochloride. FDA is issuing this final rule after considering data and information submitted in response to the Agency's proposed labeling revisions for these products. This final rule is part of FDA's ongoing review of OTC drug products.
mesh_terms: D018926:Anti-Allergic Agents / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use; D000996:Antitussive Agents / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D003139:Common Cold / Q000188:drug therapy; D003371:Cough / Q000188:drug therapy; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D004809:Ephedrine / Q000009:adverse effects; D004837:Epinephrine / Q000009:adverse effects; D006801:Humans; D007880:Legislation, Drug; D004366:Nonprescription Drugs / Q000627:therapeutic use*; D064705:Racepinephrine; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D018926:Anti-Allergic Agents; D018927:Anti-Asthmatic Agents; D000996:Antitussive Agents; D001993:Bronchodilator Agents; D004366:Nonprescription Drugs; D004809:Ephedrine; D064705:Racepinephrine; D004837:Epinephrine