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Labeling for Bronchodilators to Treat Asthma - Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products, etc. (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library

Labeling for Bronchodilators to Treat Asthma - Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products, etc. (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Labeling for Bronchodilators to Treat Asthma - Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products, etc. (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 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. This book contains: - The complete text of the Labeling for Bronchodilators to Treat Asthma - Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products, etc. (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section