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Label Changes for:

Janumet XR (sitagliptin and metformin HCl Extended-Release) Tablets 

February 2014

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


February 2014


17.1 Instructions
  • Patients should be informed that incompletely dissolved JANUMET XR tablets may be eliminated in the feces. Tell patients that, if they repeatedly see tablets in feces, they should report this finding to their healthcare provider. If a patient reports repeatedly observing tablets in feces, the healthcare provider should assess adequacy of glycemic control.


  • You may see something that looks like the JANUMET XR tablet in your stool (bowel movement). If you see tablets in your stool several times, talk to your doctor. Do not stop taking JANUMET XR without talking to your doctor.