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Labeling for Bronchodilators To Treat Asthma; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use

other · Food and Drug Administration · Rule · Published 2011-07-26 · Effective 2012-01-23 · 76 FR 44475

Document

Document number
2011-18347
Federal Register citation
76 FR 44475
CFR reference
21 CFR 201
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2011-07-26
Effective date
2012-01-23
HHS docket
Docket No. FDA-1995-N-0031 (Formerly Docket No. 1995N-0205)

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.

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Authoritative
Federal Register document
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