Document

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

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...

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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''.

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] BILLING CODE 4160-01-F

[GRAPHIC] [TIFF OMITTED] TR01DE98.008

[FR Doc. 98-31854 Filed 11-30-98; 8:45 am] BILLING CODE 4160-01-C

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

63 FR 66015

Web Citation

Suggested Web Citation

Use this when citing the archival web version of the document.

“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,” thefederalregister.org (December 1, 1998), https://thefederalregister.org/documents/98-31854/internal-analgesic-antipyretic-and-antirheumatic-drug-products-for-over-the-counter-human-use-final-rule-for-professiona.