Labeling for bronchodilators to treat asthma; cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. Final rule.Fed Regist. 2011 Jul 26; 76(143):44475-89.FR
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.