{"abstract":"The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that would establish alcohol warnings for all over- the-counter (OTC) drug products containing internal analgesic/ antipyretic active ingredients labeled for adult use. The proposed warning statements advise consumers who have a history of heavy alcohol use or abuse to consult a physician for advice about the use of OTC internal analgesic/antipyretic drug products. A warning would be required for all OTC internal analgesic/antipyretic drug products marketed under an OTC drug monograph or an approved new drug application (NDA). FDA is issuing this notice of proposed rulemaking after considering the reports and recommendations of its Nonprescription Drugs Advisory Committee (NDAC) and Arthritis Drugs Advisory Committee (ADAC), public comments on the proposed rule for OTC internal analgesic, antipyretic, and antirheumatic drug products, and other available information.","action":"Notice of proposed rulemaking.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/1997/11/14/97-30035.html","cfr_references":[{"chapter":null,"citation_url":null,"part":201,"title":21}],"citation":"62 FR 61041","comment_url":null,"comments_close_on":"1998-01-28","correction_of":null,"corrections":[],"dates":"Written comments by January 28, 1998. Written comments on the agency's economic impact determination by January 28, 1998. The agency is proposing that any final rule based on this proposal be effective 6 months after the date of its publication in the Federal Register.","disposition_notes":null,"docket_ids":["Docket No. 77N-094W"],"dockets":[],"document_number":"97-30035","effective_on":null,"end_page":61057,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1997/11/14/97-30035/over-the-counter-drug-products-containing-analgesicantipyretic-active-ingredients-for-internal-use","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/97-30035?publication_date=1997-11-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1997-11-14/97-30035/mods.xml","not_received_for_publication":null,"page_length":17,"page_views":{"count":106,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1997-11-14/pdf/97-30035.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1997-11-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1997/11/14/97-30035.txt","regulation_id_number_info":{"0910-AA01":{"issue":"200310","html_url":"https://www.federalregister.gov/regulations/0910-AA01/over-the-counter-otc-drug-review","title":"Over-the-Counter (OTC) Drug Review","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=200310&RIN=0910-AA01&operation=OPERATION_EXPORT_XML","priority_category":"Routine and Frequent"}},"regulation_id_numbers":["0910-AA01"],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":61041,"subtype":null,"title":"Over the-Counter Drug Products Containing Analgesic/Antipyretic Active Ingredients for Internal Use; Required Alcohol Warning","toc_doc":null,"toc_subject":null,"topics":[],"type":"Proposed Rule","volume":62}