[Federal Register Volume 63, Number 230 (Tuesday, December 1, 1998)]
[Rules and Regulations]
[Pages 66015-66017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31854]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 343

[Docket No. 77N-094A]


Internal Analgesic, Antipyretic, and Antirheumatic Drug Products 
for Over-The-Counter Human Use; Final Rule for Professional Labeling of 
Aspirin, Buffered Aspirin, and Aspirin in Combination With Antacid 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 October 23, 1998 (63 FR 
56802). The document provided for professional labeling for over-the-
counter (OTC) internal analgesic, antipyretic, and antirheumatic drug 
products containing aspirin, buffered aspirin, and aspirin in 
combination with an antacid. The document published with some 
inadvertent editorial errors. This document corrects those errors.

EFFECTIVE DATE: The regulation is effective October 25, 1999.

FOR FURTHER INFORMATION CONTACT: Ida I. Yoder, 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. 98-28519, appearing on page 
56802, in the Federal Register of October 23, 1998, the following 
corrections are made:
     1. On page 56809, in Table 5, in the second entry in the fourth 
column, ``-3.9'' is corrected to read ``-39''.
     2. On page 56810, in the third column, in the eighteenth line, 
``preoperative'' is corrected to read ``perioperative''.
     3. On page 56812, in the first column, in the third paragraph, in 
the eighteenth line, ``were'' is corrected to read ``was''.


 Sec. 343.80   [Corrected]

     4. On page 56817, in Sec. 343.80(a)(1), the last paragraph is 
corrected to read ``REV: October 23, 1998''.

[[Page 66016]]

    5. On page 56818, in Sec. 343.80(a)(2), the entire page 
``HIGHLIGHTS OF PRESCRIBING INFORMATION'' is corrected to read as 
follows:

    Dated: November 20, 1998.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc 98-31854 Filed 11-30-98; 8:45 am]
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[FR Doc. 98-31854 Filed 11-30-98; 8:45 am]
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