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Label Changes for:

Azulfidine (Sulfasalazine) 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

 

PRECAUTIONS

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

 

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