[Federal Register Volume 68, Number 71 (Monday, April 14, 2003)]
[Rules and Regulations]
[Page 17881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9067]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 341

[Docket No. 76N-052G]
RIN 0910-AA01


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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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:


Sec.  341.40  [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:''


Sec.  341.70  [Corrected]

    2. On page 78170, in the second column, in Sec.  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.
[FR Doc. 03-9067 Filed 4-11-03; 8:45 am]
BILLING CODE 4160-01-S