Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Final Monograph for Combination Drug Products; Correction

---
identifier: "/us/fr/03-9067"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Final Monograph for Combination Drug Products; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "03-9067"
section_name: "Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Final Monograph for Combination Drug Products; Correction"
positive_law: false
currency: "2003-04-14"
last_updated: "2003-04-14"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "03-9067"
document_type: "rule"
publication_date: "2003-04-14"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 341"
rin: "0910-AA01"
fr_citation: "68 FR 17881"
fr_volume: 68
docket_ids:
  - "Docket No. 76N-052G"
effective_date: "2004-12-23"
fr_action: "Final rule; correction."
---


#  [Corrected]

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Final rule; correction.

**SUMMARY:**

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the *Federal Register* of December 23, 2002 (67 FR 78158). The document issued a final monograph that established 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.

**DATES:**

The regulation is effective December 23, 2004.

**FOR FURTHER INFORMATION CONTACT:**

Cazemiro R. Martin or Gerald M. Rachanow, Center for Drug Evaluation and Research (HFD-560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2222.

**SUPPLEMENTARY INFORMATION:**

In FR Doc. 02-32158 appearing on page 78158 in the *Federal Register* of Monday, December 23, 2002, the following corrections are made:

§ 341.40

1. On page 78168, in the second column, in Part 341 *Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use* , under the authority citation, in amendment 2, “Section 341.40 is added to subpart C to read as follows:” is corrected to read “Section 341.40 is added to subpart B to read as follows:”

§ 341.70

2. On page 78170, in the second column, in § 341.70 *Labeling of OTC drug products containing ingredients that are used for treating concurrent symptoms (in either a single-ingredient or combination drug product)* , in paragraph (b), “Repeat every hour as needed or as directed by a doctor.” is corrected to read “Repeat every 2 hours as needed or as directed by a doctor.”

Dated: April 8, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.