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Label Changes for:

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

December 2008

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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.

Summary View


Sections Modified


  • 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.