United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 1998_register executive 2010-09-24 article Rules and Regulations D09002ee1bdfedbb4 D09002ee1bdfee129 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is issuing as a final rule 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. This portion of the final monograph is being issued prior to the entire monograph so that the professional labeling of these products will reflect the latest information on cardiovascular, cerebrovascular, and rheumatologic uses. FDA is issuing this final rule after considering comments on the agency's proposed regulation for OTC internal analgesic, antipyretic, and antirheumatic drug products, a proposed amendment to the regulation, and data and information that have come to the agency's attention. 63 FR 56802 https://www.govinfo.gov/app/details/FR-1998-10-23/98-28519 98-28519 fr23oc98-8 RIN 0910-AA01 4160-01-F Docket No. 77N-094A https://www.govinfo.gov/app/details/FR-1998-10-23/98-28519 https://www.govinfo.gov/content/pkg/FR-1998-10-23/html/98-28519.htm https://www.govinfo.gov/content/pkg/FR-1998-10-23/pdf/98-28519.pdf 18 p. 56802 56819 63 FR 56802 Title 21 Part 343 21 CFR Part 343 RIN 0910-AA01 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; Federal Register Vol. 63, Issue RULE 98-28519 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. 77N-094A 4160-01-F 98-28519 Final rule.

The Food and Drug Administration (FDA) is issuing as a final rule 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. This portion of the final monograph is being issued prior to the entire monograph so that the professional labeling of these products will reflect the latest information on cardiovascular, cerebrovascular, and rheumatologic uses. FDA is issuing this final rule after considering comments on the agency's proposed regulation for OTC internal analgesic, antipyretic, and antirheumatic drug products, a proposed amendment to the regulation, and data and information that have come to the agency's attention.

October 25, 1999. Ida I. Yoder, Center for Drug Evaluation and Research (HFD-560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2222. Vol. 63, no. 205 Office of the Federal Register, National Archives and Records Administration 1998-10-23 continuing daily deposited born digital 276 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1998-10-23 P0b002ee180a6ccbb 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr23oc98 https://www.govinfo.gov/app/details/FR-1998-10-23 https://www.govinfo.gov/content/pkg/FR-1998-10-23/pdf/FR-1998-10-23.pdf fdlp 56781 57044 DGPO 2010-09-24 2023-05-06 FR-1998-10-23 machine generated eng FR FR-1998-10-23 63 205