# Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-The-Counter Human Use; Final Monograph for Combination Drug Products
> **Food and Drug Administration** · Final rule. · Published 2002-12-23 · Effective 2004-12-23 · 67 FR 78158
## Document
- **Document number:** 02-32158
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 67 FR 78158
- **CFR reference:** 21 CFR 341
- **Publication date:** 2002-12-23
- **Effective date:** 2004-12-23
- **HHS docket:** Docket No. 76N-052G
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph that establishes conditions under which over-the-counter (OTC) cold, cough, allergy, bronchodilator, and antiasthmatic (cough-cold) combination drug products are generally recognized as safe and effective and not misbranded as part of its ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on the agency's proposed regulation (tentative final monograph) and new data and information on OTC cough- cold combination drug products that have come to the agency's attention.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2002/12/23/02-32158/cold-cough-allergy-bronchodilator-and-antiasthmatic-drug-products-for-over-the-counter-human-use)
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