# Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Partial Final Rule for Combination Drug Products Containing a Bronchodilator; Correction
> **Food and Drug Administration** · Final rule; correction. · Published 2001-10-19 · Effective 2001-10-19 · 66 FR 53088
## Document
- **Document number:** 01-26315
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 66 FR 53088
- **CFR reference:** 21 CFR 310
- **Publication date:** 2001-10-19
- **Effective date:** 2001-10-19
- **HHS docket:** Docket No. 76N-052G
## Abstract

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of September 27, 2001 (66 FR 49276). The document issued a final rule establishing that cough-cold combination drug products containing any oral bronchodilator active ingredient in combination with any analgesic(s) or analgesic- antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient are not generally recognized as safe and effective and are misbranded for over-the-counter (OTC) use. The document published with two inadvertent errors. This document corrects those errors.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2001/10/19/01-26315/cold-cough-allergy-bronchodilator-and-antiasthmatic-drug-products-for-over-the-counter-human-use)
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