# Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph for Over-the-Counter Nasal Decongestant Drug Products
> **Food and Drug Administration** · Final rule. · Published 2005-10-11 · Effective 2007-04-11 · 70 FR 58974
## Document
- **Document number:** 05-20304
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 70 FR 58974
- **CFR reference:** 21 CFR 310
- **Publication date:** 2005-10-11
- **Effective date:** 2007-04-11
- **HHS docket:** Docket No. 2004N-0289
## Abstract

The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) nasal decongestant drug products (drug products used to relieve nasal congestion due to a cold, hay fever, or other upper respiratory allergies) to remove the indication "for the temporary relief of nasal congestion associated with sinusitis" and to prohibit use of the terms "sinusitis" and "associated with sinusitis" elsewhere on the labeling. This final rule is part of FDA's ongoing review of OTC drug products.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2005/10/11/05-20304/cold-cough-allergy-bronchodilator-and-antiasthmatic-drug-products-for-over-the-counter-human-use)
---
*AI Analytics · CC0 1.0*