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Acetaminophen Information
The Food and Drug Administration (FDA) convened a public advisory committee meeting on June 29 and June 30, 2009 regarding acetaminophen use in both over-the-counter (OTC) and prescription (Rx) products, the potential for liver injury, and potential interventions to reduce the incidence of liver injury.
The FDA will keep the docket for this meeting open until September 30th 2009 to receive comments. Electronic comments should be submitted to www.regulations.gov. Enter "FDA-2009-N-0138 Liver Injury Related to the Use of Acetaminophen'' and look for the Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee and the Anesthetic and Life Support Drugs Advisory Committee: Notice of Meeting. Click on "Send a Comment or Submission." Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. If you have any questions or problems with your submission to the docket, please call the Division of Dockets Management at (301) 827-6860.
Acetaminophen Labeling and Safety
- Using Acetaminophen and Nonsteroidal Anti-inflammatory Drugs Safely
- FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely
- Acetaminophen and Liver Injury: Q & A for Consumers
- El acetaminofeno y las lesiones hepáticas: Preguntas y respuestas para los consumidores
Meeting Information on the Final Rule for Additional Labeling
- June 29-30, 2009: Joint Meeting of the Drug Safety and Risk Management Advisory Committee with the Anesthetic and Life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee: Meeting Announcement
- Acetaminophen Final Rule (PDF - 56KB)
- Questions and Answers on Final Rule for Labeling Changes to Over-the-Counter Pain Relievers
Additional Information
- Science Background: Safety Concerns Associated with Over-the-Counter Drug Products Containing Analgesic/Antipyretic Active Ingredients for Internal Use (PDF - 20KB)
- Letter to State Boards Of Pharmacy on Acetaminophen (PDF - 19KB)
- Questions and Answers About Acetaminophen and Liver Injury for Consumers mp3 (MP3 - 8977KB)
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