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

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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.

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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.

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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:

[Corrected]

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:”

[Corrected]

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.”

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Dated: April 8, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 03-9067 Filed 4-11-03; 8:45 am]

BILLING CODE 4160-01-S