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
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…
