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U.S. Department of Health and Human Services

Safety

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OsmoPrep, (sodium phosphate monobasic monohydrate, USP & sodium phosphate dibasic anhydrous, USP) Tablets December 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- December 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

ADVERSE REACTIONS

  • Postmarketing Experience
    • General
      • bronchospasm, dyspnea, dysphagia (added)
    • Renal (new subsection)
      • Renal impairment, increased blood urea nitrogen (BUN), increased creatinine, acute renal failure, nephrocalcinosis, and renal tubular necrosis.

 

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