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Label Changes for:

Azulfidine EN-Tabs (Sulfasalazine Delayed Release) Tablets, USP

December 2012

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) – December 2012



Nursing Mothers
  • There have been five reports with limited data of bloody stools or diarrhea in human milk fed infants of mothers taking sulfasalazine…