sodium sulfate, potassium sulfate, and magnesium sulfate 1.6 g/177mL
sodium sulfate, potassium sulfate, and magnesium sulfate · SOLUTION · Bionpharma Inc.,
This oral solution contains a combination of mineral salts used to cleanse the bowel before medical procedures or to treat constipation. It works by drawing water into the intestines to promote bowel movements.
Key Facts
- Brand Name
- sodium sulfate, potassium sulfate, and magnesium sulfate
- Generic Name
- sodium sulfate, potassium sulfate, and magnesium sulfate
- NDC Code (Product)
69452-428- Manufacturer
- Bionpharma Inc.,
- Strength
- 1.6 g/177mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204135
- Marketing Start
- 04/15/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult patients. Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adult patients. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Preparation and Administration ( 2.2 ) Must dilute in water prior to ingestion. Administration of two bottles of sodium sulfate, potassium sulfate and magnesium sulfate oral solution is required for a complete preparation for colonoscopy. One bottle is equivalent to one dose. Must consume additional water after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy. Recommended Dosage and Administration Split-Dose (two-day) regimen consists of two doses of sodium sulfate, potassium sulfate and magnesium sulfate oral solution: first dose during the evening prior to colonoscopy and second dose the next day, during the morning of colonoscopy. ( 2.1 , 2.3 ) Recommended sodium sulfate, potassium sulfate and magnesium sulfate oral solution dosage is: o Adults: Two 6-ounce doses. ( 2.3 ) For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing Information. ( 2.1 , 2.2 , 2.3 ) 2.1 Dosage and Administration Overview Administration of two bottles of sodium sulfate, potassium sulfate and magnesium sulfate oral solution and additional water is required for a complete preparat…
Contraindications
4 CONTRAINDICATIONS Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is contraindicated in the following conditions: Gastrointestinal obstruction or ileus [see Warnings and Precautions ( 5.6 )] Bowel perforation [see Warnings and Precaution ( 5.6 )] Toxic colitis or toxic megacolon Gastric retention Hypersensitivity to any of the ingredients in sodium sulfate, potassium sulfate and magnesium sulfate oral solution Gastrointestinal obstruction or ileus ( 4 , 5.6 ) Bowel perforation ( 4 , 5.6 ) Toxic colitis or toxic megacolon ( 4 ) Gastric retention ( 4 ) Hypersensitivity to any ingredient ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Drugs that increase risk of fluid and electrolyte imbalance. ( 7.1 ) Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 7.1 Drugs That May Increase Risk of Fluid and Electrolyte Abnormalities Use caution when prescribing sodium sulfate, potassium sulfate and magnesium sulfate oral solution to patients taking medications that increase the risk of fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 )] . 7.2 Potential for Reduced Drug Absorption Sodium sulfate, potassium sulfate and magnesium sulfate oral solution can reduce the absorption of other co-administered drugs [see Dosage and Administration ( 2.1 )] . Administer oral medications at least one hour before starting each dose of sodium sulfate, potassium sulfate and magnesium sulf…
Adverse Reactions
6 ADVERSE REACTIONS The following important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Serum Chemistry Abnormalities [see Warnings and Precautions ( 5.1 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] Seizures [see Warnings and Precautions ( 5.3 )] Use in Patients with Risk of Renal Injury [see Warnings and Precautions ( 5.4 )] Colonic Mucosal Ulceration and Ischemic Colitis [see Warnings and Precautions ( 5.5 )] Patients with Significant Gastrointestinal Disease [see Warnings and Precautions ( 5.6 )] Aspiration [see Warnings and Precautions ( 5.7 )] Most common adverse reactions are: Adults (>2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. …
Frequently Asked Questions
What is sodium sulfate, potassium sulfate, and magnesium sulfate used for?
This oral solution contains a combination of mineral salts used to cleanse the bowel before medical procedures or to treat constipation. It works by drawing water into the intestines to promote bowel movements.
Is sodium sulfate, potassium sulfate, and magnesium sulfate a controlled substance?
sodium sulfate, potassium sulfate, and magnesium sulfate is not classified as a controlled substance by the DEA.
What is the generic name for sodium sulfate, potassium sulfate, and magnesium sulfate?
The generic name for sodium sulfate, potassium sulfate, and magnesium sulfate is sodium sulfate, potassium sulfate, and magnesium sulfate. There are no other listed brand versions of sodium sulfate, potassium sulfate, and magnesium sulfate.
What is the NDC code for sodium sulfate, potassium sulfate, and magnesium sulfate 1.6 g/177mL?
The NDC (National Drug Code) for sodium sulfate, potassium sulfate, and magnesium sulfate 1.6 g/177mL is 69452-428, listed by Bionpharma Inc.,.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)