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