Drugs
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Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription)
Oral sodium phosphate products (OSP) are used for bowel cleansing prior to colonoscopy or other medical procedures.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.
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Related Information
Information for Healthcare Professionals: Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription)
12/11/2008FDA Requires New Safety Measures for Oral Sodium Phosphate Products to Reduce Risk of Acute Kidney Injury
FDA News Release (12/11/2008)Oral Sodium Phosphate (OSP) Actions Questions and Answers Oral Sodium Phosphate (OSP) Products R.E.M.S. (PDF - 84KB)
Letter and REMS information (12/11/2008)Citizen Petition-Natasha Leskovsek, September 2007 (Docket No. FDA-2007-P-0345) (PDF - 150KB)Citizen Petition-C.B. Fleet, Inc., June 2003 (Docket No. FDA-1978-N-0021) (PDF - 106KB)Historical Information on Oral Sodium Phosphate (OSP) Products for Bowel Cleansing
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Labeling Information
Prescribing and Label Information for Osmoprep
from Drugs@FDAPrescribing and Label Information for Visicol
from Drugs@FDA
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