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Label Changes for:

Asacol (mesalamine) 400 mg delayed-release tablets

September 2009

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009


Use in Hepatic Impairment  
  • There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine.  Caution should be exercised when administering Asacol to patients with liver disease.
Information for Patients
  • (reworded) taking care not to break cut, or chew the  tablets, because the coating is an important part of the delayed-release formulation.