[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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[[Page 66017]]
[GRAPHIC] [TIFF OMITTED] TR01DE98.008
[FR Doc. 98-31854 Filed 11-30-98; 8:45 am]
BILLING CODE 4160-01-C
