Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral 17.5 g/177mL; 3.13 g/177mL; 1.6 g/177mL Solution
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Magnesium sulfate, potassium sulfate, and sodium sulfate is used to empty the colon (large intestine, bowel) before a colonoscopy (examination of the inside of the colon to check for colon cancer and other abnormalities) in adults and children 12 years of age and older so that the doctor will have a clear view of the walls of the colon. Magnesium sulfate, potassium sulfate, and sodium sulfate is in a class of medications called osmotic laxatives. It works by causing watery diarrhea so that the stool can be emptied from the colon.
Read the full MedlinePlus article ↗- This solution works by drawing water into your intestines so your bowel is thoroughly flushed out before your colonoscopy — your doctor needs a clear, clean view of the colon wall....
- What exactly does this prep do, and why do I have to drink so much water with it?
- Yes, but timing matters. Take all your regular oral medications at least one hour before you start each dose of the prep, since the solution can reduce how well your body absorbs o...
- Can I take my regular medications while I'm doing the prep?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
-
UNII 817L1N4CKP
Malic acid is a naturally occurring organic acid found in fruits. It works as a buffer and flavor agent to maintain the medicine's pH balance and add tartness to the product.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
-
UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
-
UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.093 | $32.89 / 354 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.1797 | $63.61 / 354 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sodium sulfate, potassium sulfate and magnesium sulfate 17.5 g/177mL; 3.13 g/177mL; 1.6 g/177mL 31722-0098-31 | Camber | 2 bottles | $0.093 | AA | Availability likely | — |
| Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral 17.5 g/177mL; 3.13 g/177mL; 1.6 g/177mLthis 64380-0116-01 | Strides | 2 bottles | $0.093 | AA | Availability likely | — |
| Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate 17.5 g/177mL; 3.13 g/177mL; 1.6 g/177mL 67877-0725-92 | Ascend | 2 bottles | $0.093 | AA | Availability likely | — |
| Sodium sulfate, potassium sulfate and magnesium sulfate 17.5 g/177mL; 3.13 g/177mL; 1.6 g/177mL 72603-0278-02 | NorthStar | 2 bottles | $0.093 | AA | Availability likely | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 64380-0116-01 You're viewing this | 2 BOTTLE in 1 CARTON (64380-116-01) / 177 mL in 1 BOTTLE (64380-116-02) | 2024-01-17 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. 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 and pediatric patients 12 years of age and older (1).
⏱️ Dosage and 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, 2.4) Recommended sodium sulfate, potassium sulfate and magnesium sulfate oral solution dosage is: Adults: Two 6-ounce doses.
(2.3) Pediatric Patients 12 Years of Age and Older: Two 4.5-ounce doses. (2.4) For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing Information. (2.1, 2.2, 2.3, 2.4)
2.1Dosage 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 preparation for colonoscopy. One bottle of sodium sulfate, potassium sulfate and magnesium sulfate oral solution is equivalent to one dose. Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is supplied in two dosage strengths [see Dosage Forms and Strengths (3)] .
The recommended dosage is: Adults : Two 6-ounce doses [see Dosage and Administration (2.3)] . Pediatric patients 12 years of age and older: Two 4.5-ounce doses [see Dosage and Administration (2.4)] .
2.2Important Preparation and Administration Instructions Correct fluid and electrolyte abnormalities before treatment with sodium sulfate, potassium sulfate and magnesium sulfate oral solution [see Warnings and Precautions (5.1)] Must dilute sodium sulfate, potassium sulfate and magnesium sulfate oral solution in water before ingestion. Must consume additional water after each dose of sodium sulfate, potassium sulfate and magnesium sulfate oral solution. On the day before colonoscopy, consume only a light breakfast or clear liquids (e.g., water, strained fruit juice without pulp, lemonade, plain coffee or tea, chicken broth, gelatin dessert without fruit).
On the day of the colonoscopy only consume clear liquids up to two hours prior to colonoscopy. Do not eat solid food or drink milk or eat or drink anything colored red or purple. Do not drink alcohol.
Do not take other laxatives while taking sodium sulfate, potassium sulfate and magnesium sulfate oral solution. Do not take oral medications within one hour of starting each dose of sodium sulfate, potassium sulfate and magnesium sulfate oral solution. If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of sodium sulfate, potassium sulfate and magnesium sulfate oral solution [see Drug Interactions (7.2)] .
Stop consumption of all fluids at least 2 hours prior to the colonoscopy.
2.3Recommended Dosage and Administration for Adults The recommended Split-Dose (two-day) regimen for adults consists of two 6-ounce doses of sodium sulfate, potassium sulfate and magnesium sulfate oral solution: the first dose during the evening prior to colonoscopy and the second dose the next day, during the morning of the colonoscopy. Each dose consists of one bottle of sodium sulfate, potassium sulfate and magnesium sulfate oral solution with additional water. The total volume of liquid required for colon cleansing (using two bottles) is 3 quarts.
The following are recommended dosage and administration instructions for adults: Dose 1 – On the Day Prior to Colonoscopy: May consume a light breakfast, or only clear liquids (no solid food). In th…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Sodium sulfate, potassium sulfate and magnesium sulfate oral solution (for adults) : Two bottles in a carton, each bottle containing 6 ounces of an oral solution of 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate as a clear to slightly hazy liquid. When diluted as directed, the solution is clear and colorless. Sodium sulfate, potassium sulfate and magnesium sulfate oral solution (for adults) : Two bottles each containing 6 ounces of an oral solution of 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate.
(3)
⛔ 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 [see Warnings and Precautions (5.8) and Description (11)] 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 (4,5.8)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities : Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after each use. (5.1, 7.1) Cardiac arrhythmias : Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. (5.2) Seizures : Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold.
(5.3, 7.1) Patients with renal impairment or taking concomitant medications that affect renal function : Use caution, ensure adequate hydration and consider laboratory testing. (5.4, 7.1) Suspected GI obstruction or perforation: Rule out the diagnosis before administration. (4, 5.6) Patients at risk for aspiration : Observe during administration.
(5.7) Hypersensitivity reactions, including anaphylaxis : Inform patients to seek immediate medical care if symptoms occur. (5.8)
5.1Serious Fluid and Serum Chemistry Abnormalities Advise all patients to hydrate adequately before, during, and after the use of sodium sulfate, potassium sulfate and magnesium sulfate oral solution. If a patient develops significant vomiting or signs of dehydration after taking sodium sulfate, potassium sulfate and magnesium sulfate oral solution, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment.
Correct fluid and electrolyte abnormalities before treatment with sodium sulfate, potassium sulfate and magnesium sulfate oral solution. Use sodium sulfate, potassium sulfate and magnesium sulfate oral solution with caution in patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment [see Drug Interactions (7.1)] . Sodium sulfate, potassium sulfate and magnesium sulfate oral solution can cause temporary elevations in uric acid. [ See Adverse Reactions (6.1) ].
Uric acid fluctuations in patients with gout may precipitate an acute flare. The potential for uric acid elevation should be considered before administering sodium sulfate, potassium sulfate and magnesium sulfate oral solution to patients with gout or other disorders of uric acid metabolism.
5.2Cardiac Arrhythmias There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing sodium sulfate, potassium sulfate and magnesium sulfate oral solution for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.
5.3Seizures There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.
Use caution when prescribing sodium sulfate, potassium sulfate and magnesium sulfate oral solution for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia [see Drug Interactions (7.1)] .
5.4Use in Patients with Risk of Renal Injury Use sodium sulfate, potassium sulfate and magnesium sulfate oral soluti…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions are: Adults (>2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting. (6.1) Pediatric Patients (>10%): nausea, abdominal pain, abdominal bloating and vomiting. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. at 1-877-244-9825 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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)] Hypersensitivity Reactions [see Warnings and Precautions (5.8)]
6.1Clinical Trials 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. Adults The safety of sodium sulfate, potassium sulfate and magnesium sulfate oral solution was evaluated in a multi-center, randomized, active controlled trial in 379 adult patients undergoing colonoscopy [see Clinical Studies (14)] .
Most Common Adverse Reactions Table 1 shows the most common adverse reactions reported in at least 2% of patients receiving sodium sulfate, potassium sulfate and magnesium sulfate oral solution or the control (a bowel prep containing polyethylene glycol and electrolytes (PEG + E)) administered in split-dose (2-day) regimens. Table 1: Common Adverse Reactions* in Adult Patients Undergoing Colonoscopy in a Randomized, Active Controlled Trial * reported in at least 2% of patients Symptom Split-Dose (2-Day) Regimen Sodium sulfate, potassium sulfate and magnesium sulfate oral solution % N=190 PEG + E product % N=189 Overall Discomfort 54 67 Abdominal Distension 40 52 Abdominal Pain 36 43 Nausea 36 33 Vomiting 8 4 Laboratory Abnormalities Table 2 shows the most common laboratory abnormalities (at least 10% in either treatment group and more than 2% difference between groups) for patients who developed new abnormalities of important electrolytes and uric acid after completing the bowel preparation with either sodium sulfate, potassium sulfate and magnesium sulfate oral solution or PEG+E administered as a split-dose (2-day) regimen.
Table 2: Adult Patients with Normal Baseline Serum Chemistry with A Shift to an Abnormal Value While on the Split-Dose (2-Day) Regimen 1 1 The study was not designed to support comparative claims for the laboratory abnormalities reported in this table. 2 Percent (n/N) of patients where N=number of patients with normal baseline who had abnormal values at the time point(s) of interest. Day of Colonoscopy N (%) 2 Day 30 N (%) 2 Bicarbonate (low) Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 20 (13) 7 (4) PEG + Electrolytes 24 (15) 4 (3) Bilirubin, total (high) Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 14 (9) 0 (0) PEG + Electrolytes 20 (12) 3 (2) BUN (high) Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 2 (2) 14 (11) PEG + Electrolytes 4 (3) 19 (15) Calcium (high) Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 16 (10) 8 (5) PEG + Electrolytes 6 (4) 6 (4) Chloride (high) Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 4 (2) 6 (4) PEG + Electrolytes 20 (12) 6 (4) Osmolality (high) Sodium sulfate, potassium sulfate and magnesium sulfate oral solution 8 (6) NA PEG + Electrolytes 19 (13) NA Uric acid (high) Sodium sulfate, potassium sulfate and magnesium sulfa…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Drugs that increase risk of fluid and electrolyte imbalance. (7.1)
7.1Drugs That May Increase Risks 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)].
7.2Potential 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 sulfate oral solution. Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of sodium sulfate, potassium sulfate and magnesium sulfate oral solution to avoid chelation with magnesium.
7.3Stimulant Laxatives Concurrent use of stimulant laxatives and sodium sulfate, potassium sulfate and magnesium sulfate oral solution may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking sodium sulfate, potassium sulfate and magnesium sulfate oral solution [see Warnings and Precautions (5.5)] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on sodium sulfate, potassium sulfate and magnesium sulfate oral solution use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproductive studies have not been conducted with sodium sulfate, potassium sulfate, and magnesium sulfate (sodium sulfate, potassium sulfate and magnesium sulfate oral solution). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
8.2Lactation Risk Summary There are no data available data on the presence of sodium sulfate, potassium sulfate and magnesium sulfate oral solution in human or animal milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for sodium sulfate, potassium sulfate and magnesium sulfate oral solution and any potential adverse effects on the breastfed child from sodium sulfate, potassium sulfate and magnesium sulfate oral solution or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of sodium sulfate, potassium sulfate and magnesium sulfate oral solution (two 4.5-ounce doses) have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 12 years of age and older. Use of sodium sulfate, potassium sulfate and magnesium sulfate oral solution in this age group is supported by evidence from an adequate and well-controlled trial of sodium sulfate, potassium sulfate and magnesium sulfate oral solution in adults and a single, dose-ranging, controlled trial in 89 pediatric patients 12 years to 16 years of age [see Clinical Studies ( 14)] .
In the pediatric trial, sodium sulfate, potassium sulfate and magnesium sulfate oral solution (two 6-ounce doses) did not demonstrate additional treatment benefit and more patients reported gastrointestinal adverse reactions compared to sodium sulfate, potassium sulfate and magnesium sulfate oral solution (two 4.5-ounce doses). Therefore, sodium sulfate, potassium sulfate and magnesium sulfate oral solution (two 6-ounce doses) is not recommended for pediatric patients 12 years of age and older [see Dosage and Administration (2.3)] .
The safety profile of sodium sulfate, potassium sulfate and magnesium sulfate oral solution (two 4.5-ounce doses) in this pediatric population was similar to that seen in adults [see Adverse Reactions (6.1)] . The safety and effectiveness of sodium sulfate, potassium sulfate and magnesium sulfate oral solution in pediatric patients less than 12 years of age have not been established.
8.5Geriatric Use Of the 375 patients who received sodium sulfate, potassium sulfate and magnesium sulfate oral solution in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of sodium sulfate, potassium sulfate and magnesium sulfate oral solution administered as the recommended split-dose (2-day) regimen were observed between geriatric patients and younger patients. Geriatric patients reported more vomiting when sodium sulfate, potassium sulfate and magnesium sulfate oral solution was given as a one-day preparation (not a recommended regimen).
Elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see Warnings and Precautions (5.1)] .
8.6 Renal Impairment Use sodium sulfate, potassium sulfate and magnesium sulfate o…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on sodium sulfate, potassium sulfate and magnesium sulfate oral solution use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproductive studies have not been conducted with sodium sulfate, potassium sulfate, and magnesium sulfate (sodium sulfate, potassium sulfate and magnesium sulfate oral solution). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of sodium sulfate, potassium sulfate and magnesium sulfate oral solution (two 4.5-ounce doses) have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 12 years of age and older. Use of sodium sulfate, potassium sulfate and magnesium sulfate oral solution in this age group is supported by evidence from an adequate and well-controlled trial of sodium sulfate, potassium sulfate and magnesium sulfate oral solution in adults and a single, dose-ranging, controlled trial in 89 pediatric patients 12 years to 16 years of age [see Clinical Studies ( 14)] .
In the pediatric trial, sodium sulfate, potassium sulfate and magnesium sulfate oral solution (two 6-ounce doses) did not demonstrate additional treatment benefit and more patients reported gastrointestinal adverse reactions compared to sodium sulfate, potassium sulfate and magnesium sulfate oral solution (two 4.5-ounce doses). Therefore, sodium sulfate, potassium sulfate and magnesium sulfate oral solution (two 6-ounce doses) is not recommended for pediatric patients 12 years of age and older [see Dosage and Administration (2.3)] .
The safety profile of sodium sulfate, potassium sulfate and magnesium sulfate oral solution (two 4.5-ounce doses) in this pediatric population was similar to that seen in adults [see Adverse Reactions (6.1)] . The safety and effectiveness of sodium sulfate, potassium sulfate and magnesium sulfate oral solution in pediatric patients less than 12 years of age have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 375 patients who received sodium sulfate, potassium sulfate and magnesium sulfate oral solution in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of sodium sulfate, potassium sulfate and magnesium sulfate oral solution administered as the recommended split-dose (2-day) regimen were observed between geriatric patients and younger patients. Geriatric patients reported more vomiting when sodium sulfate, potassium sulfate and magnesium sulfate oral solution was given as a one-day preparation (not a recommended regimen).
Elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see Warnings and Precautions (5.1)] .
🆘 Overdosage ▾
10 OVERDOSAGE Overdosage of more than the recommended dose of sodium sulfate, potassium sulfate and magnesium sulfate oral solution may lead to severe electrolyte disturbances, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances. [see Warnings and Precautions (5.1, 5.2, 5.3)] . Monitor for fluid and electrolyte disturbances and treat symptomatically.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Sulfate salts provide sulfate anions, which are poorly absorbed. The osmotic effect of unabsorbed sulfate anions and the associated cations causes water to be retained within the gastrointestinal tract.
12.2Pharmacodynamics No formal pharmacodynamic studies have been conducted with sodium sulfate, potassium sulfate and magnesium sulfate oral solution.
12.3Pharmacokinetics Absorption and Elimination After administration of sodium sulfate, potassium sulfate and magnesium sulfate oral solution in six healthy subjects, the time at which serum sulfate reached its highest point (T max ) was approximately 17 hours after the first dose or approximately 5 hours after the second dose, and then declined with a half-life of 8.5 hours. Excretion Fecal excretion was the primary route of sulfate elimination. Specific Populations Patients with Renal Impairment The disposition of sulfate after ingestion of sodium sulfate, potassium sulfate and magnesium sulfate oral solution was studied in patients (N=6) with moderate renal impairment (creatinine clearance of 30 to 49 mL/min).
In patients with moderate renal impairment, mean AUC was 54% higher and mean C max was 44% higher, than healthy subjects. The mean sulfate concentrations in healthy subjects and in patients with moderate renal impairment returned to their respective baselines by Day 6 after dose initiation. Urinary excretion of sulfate over 30 hours after the first dose was approximately 16% lower in patients with moderate renal impairment than in healthy subjects.
These differences are not considered clinically meaningful. Patients with Hepatic Impairment The disposition of sulfate after ingestion of sodium sulfate, potassium sulfate and magnesium sulfate oral solution was studied in patients (N=6) with mild to moderate hepatic impairment (Child-Pugh grades A and B). Systemic exposure of serum sulfate (AUC and C max ) was similar between healthy subjects and patients with hepatic impairment.
The mean sulfate concentrations in healthy subjects and in patients with mild to moderate hepatic impairment returned to their respective baselines by Day 6 after dose initiation. Urinary excretion of sulfate over 30 hours after the first dose was similar between patients with hepatic impairment and healthy subjects.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Sulfate salts provide sulfate anions, which are poorly absorbed. The osmotic effect of unabsorbed sulfate anions and the associated cations causes water to be retained within the gastrointestinal tract.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Each carton of sodium sulfate, potassium sulfate and magnesium sulfate oral solution (for adults) (NDC 64380-116-01) contains: Two bottles (NDC 64380-116-02) each containing 6-ounces of an oral solution of 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate as a clear to slightly hazy liquid. When diluted as directed, the solution is clear and colorless. One (1) mixing container with a 16-ounce fill line.
Store at 20° to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F). See USP controlled room temperature.
📋 Description ▾
11 DESCRIPTION Sodium sulfate, potassium sulfate and magnesium sulfate oral solution (for adults) is an osmotic laxative and is provided as two bottles in a carton, each bottle containing 6 ounces of solution. Each bottle contains: 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. Inactive ingredients include: citric acid monohydrate USP, mixberry flavor, malic acid USP-NF, purified water, sodium benzoate USP-NF, sucralose USP-NF.
Sodium Sulfate, USP The chemical name is Na 2 SO 4 . The average Molecular Weight is 142.04. The structural formula is: Potassium Sulfate, FCC, purified The chemical name is K 2 SO 4 .
The average Molecular Weight is 174.26. The structural formula is: Magnesium Sulfate, USP The chemical name is MgSO 4 . The average Molecular Weight: 120.37.
The structural formula is: Each sodium sulfate, potassium sulfate and magnesium sulfate oral solution package also contains a polypropylene mixing container. Sodium Sulfate Potassium Sulfate Magnesium Sulfate
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). Instruct patients or caregivers: Must dilute sodium sulfate, potassium sulfate and magnesium sulfate oral solution before ingestion. Must consume additional water after each dose of sodium sulfate, potassium sulfate and magnesium sulfate oral solution.
On the day before colonoscopy, consume only a light breakfast or clear liquids (e.g., water, apple or orange juice without pulp, lemonade, coffee, tea, or chicken broth). On the day of the colonoscopy only consume clear liquids up to two hours prior to colonoscopy. Two doses of sodium sulfate, potassium sulfate and magnesium sulfate oral solution are required for a complete preparation for colonoscopy.
One bottle of sodium sulfate, potassium sulfate and magnesium sulfate oral solution is equivalent to one dose. Do not to take other laxatives while taking sodium sulfate, potassium sulfate and magnesium sulfate oral solution. Do not eat solid food or drink milk or eat or drink anything colored red or purple.
Do not drink alcohol. Do not take oral medications within one hour of starting each dose of sodium sulfate, potassium sulfate and magnesium sulfate oral solution. If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of sodium sulfate, potassium sulfate and magnesium sulfate oral solution [see Drug Interactions (7.2)] .
Stop consumption of all fluids at least 2 hours prior to colonoscopy. Contact their healthcare provider if they develop significant vomiting or signs of dehydration after taking sodium sulfate, potassium sulfate and magnesium sulfate oral solution or if they experience cardiac arrhythmias or seizures [see Warnings and Precautions (5.1, 5.2, 5.3)]. Seek immediate medical care should signs or symptoms of a hypersensitivity reaction occur [see Warnings and Precautions (5.8)] .
Manufactured by: Strides Pharma Science Limited Bengaluru – 562106, India. Distributed by: Strides Pharma Inc. Bridgewater, NJ 08807.
Revised: 03/2026
💬 Medication Guide ▾
MEDICATION GUIDE Sodium Sulfate (soe' dee um sul' fate), Potassium Sulfate (poe tas ' ee um sul' fate) and Magnesium Sulfate (mag nee' zee um sul' fate) Oral Solution Read and understand this Medication Guide at least 2 days before your colonoscopy and again before you start taking sodium sulfate, potassium sulfate and magnesium sulfate oral solution. What is the most important information I should know about sodium sulfate, potassium sulfate and magnesium sulfate oral solution? Sodium sulfate, potassium sulfate and magnesium sulfate oral solution and other bowel preparations can cause serious side effects, including: • Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood.
These changes can cause: ○ abnormal heartbeats that can cause death. ○ seizures. This can happen even if you have never had a seizure. ○ kidney problems. Your chance of having fluid loss and changes in body salts with sodium sulfate, potassium sulfate and magnesium sulfate oral solution is higher if you: • have heart problems • have kidney problems • take water pills or non-steroidal anti-inflammatory drugs (NSAIDS) Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking sodium sulfate, potassium sulfate and magnesium sulfate oral solution: ○ vomiting ○ dizziness ○ urinating less often than normal ○ headache See "What are the possible side effects of sodium sulfate, potassium sulfate and magnesium sulfate oral solution?" for more information about side effects.
What is sodium sulfate, potassium sulfate and magnesium sulfate oral solution? Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is a prescription medicine used by adults and children 12 years of age and older to clean the colon before a colonoscopy. Sodium sulfate, potassium sulfate and magnesium sulfate oral solution cleans your colon by causing you to have diarrhea.
Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. It is not known if sodium sulfate, potassium sulfate and magnesium sulfate oral solution is safe and effective in children under 12 years of age. Do not take sodium sulfate, potassium sulfate and magnesium sulfate oral solution if your healthcare provider has told you that you have: • a blockage in your intestine (bowel obstruction). • an opening in the wall of your stomach or intestine (bowel perforation). • a very dilated intestine (toxic megacolon). • problems with the emptying of food and fluid from your stomach (gastric retention). • an allergy to any of the ingredients in sodium sulfate, potassium sulfate and magnesium sulfate oral solution.
See the end of this Medication Guide for a complete list of ingredients in sodium sulfate, potassium sulfate and magnesium sulfate oral solution. Before taking sodium sulfate, potassium sulfate and magnesium sulfate oral solution, tell your healthcare provider about all of your medical conditions, including if you: • have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes). • have gout. • have heart problems including an irregular heartbeat, especially a condition called "QT prolongation". • have a history of seizures or take medicines for seizures. • are withdrawing from drinking alcohol or from taking benzodiazepines. • have a low blood salt (sodium) level. • have kidney problems or take medicines for kidney problems. • have stomach or bowel problems including ulcerative colitis. • have problems with swallowing or gastric reflux. • are pregnant or plan to become pregnant.
It is not known if sodium sulfate, potassium sulfate and magnesium sulfate oral solution will harm your unborn baby. Talk to your healthcare provider if you are pregnant. • are breastfeeding or plan to breastfeed. It is not known if sodium sulfate, potassium sulfate and magnesium sulfate oral solution passes into your breas…