Label Changes for:
Ultracet (tramadol HCl/acetaminophen) tablets
June 2011
Changes have been made to the BOXED WARNING sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2011
Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules
*APAP class change
Talacen (pentazocine hydrochloride and acetaminophen) tablets
*APAP class change
Ultracet (tramadol HCl/acetaminophen) tablets
*APAP class change
FDA limits acetaminophen in prescription combination products; requires liver toxicity warnings
- Revisions to the labeling
- This information pertains to the risk of hepatotoxicity, hypersensitivity reactions, and anaphylaxis associated with the use of the class of drugs containing acetaminophen based on new safety information about these risks identified since the product was approved.
