{"abstract":"The Food and Drug Administration (FDA) is taking steps to reduce the maximum dosage unit strength of acetaminophen in prescription drug products. This change will provide an increased margin of safety to help prevent liver damage due to acetaminophen overdosing, a serious public health problem. This notice explains the reasons for the reduction in dosage unit strength and describes how FDA is implementing it for approved prescription drug products that exceed the new maximum tablet or capsule strength. FDA is also requiring safety labeling changes, including a new boxed warning, for acetaminophen-containing prescription drug products to address new safety information about the risk of liver damage.","action":"Notice.","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/2011/01/14/2011-709.html","cfr_references":[],"citation":"76 FR 2691","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Sponsors of approved prescription drug products containing more than 325 milligrams (mg) of acetaminophen have until January 14, 2014 to request that FDA withdraw approval of the product's application, after which they may be subject to action by FDA.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0021"],"dockets":[],"document_number":"2011-709","effective_on":null,"end_page":2697,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/01/14/2011-709.xml","html_url":"https://www.federalregister.gov/documents/2011/01/14/2011-709/prescription-drug-products-containing-acetaminophen-actions-to-reduce-liver-injury-from","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-709?publication_date=2011-01-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-01-14/2011-709/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":6793,"last_updated":"2026-08-23 22:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-01-14/pdf/2011-709.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2011-01-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/01/14/2011-709.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 1 - FDA Center for Drug Evaluation and Research, Acetaminophen Overdose and Liver Injury--Background and Options for Reducing Injury, Available on FDA's Web site at http;//www.fda.gov/AdvisoryCommittee/CommitteesMeetingMaterials/Drugs/DrugsSafet","document_id":"FDA-2011-N-0021-0004"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-N-0021","supporting_documents_count":1,"docket_id":"FDA-2011-N-0021","regulation_id_number":null,"title":"Prescription Drug Products Containing Acetaminophen; Actions to Reduce Liver Injury from Unintended Overdose ","checked_regulationsdotgov_at":"2011-02-03T08:05:31Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":2691,"subtype":null,"title":"Prescription Drug Products Containing Acetaminophen; Actions To Reduce Liver Injury From Unintentional Overdose","toc_doc":"Actions to Reduce Liver Injury from Unintentional Overdose","toc_subject":"Prescription Drug Products Containing Acetaminophen:","topics":[],"type":"Notice","volume":76}