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U.S. Department of Health and Human Services

Safety

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Colyte (Peg-3350 & electrolytes) For oral solution

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2013

Summary View

 

WARNINGS AND PRECAUTIONS

Serious Fluid and Serum Chemistry Abnormalities
  • Advise patients to hydrate adequately before, during, and after the use of Colyte…
 

ADVERSE REACTIONS

Colonic Mucosal Ulcerations and Ischemic Colitis
  • Administration of osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization…