# Labeling for Bronchodilators To Treat Asthma; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
> **Food and Drug Administration** · Final rule. · Published 2011-07-26 · Effective 2012-01-23 · 76 FR 44475
## Document
- **Document number:** 2011-18347
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 76 FR 44475
- **CFR reference:** 21 CFR 201
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2011/07/26/2011-18347/labeling-for-bronchodilators-to-treat-asthma-cold-cough-allergy-bronchodilator-and-antiasthmatic)
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