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 SUPREPP® BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.'s marketing exclusivity rights, this d...
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 one dosage strength [see Dosage Forms ...
Each Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution (for adults) (NDC 51672-4170-5) contains: 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 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....
www.fda.gov/medwatch
www.sunpharma.com/usa/productsPediatric 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 indicated for cleansing of the colon as a preparation for colonoscopy in adult patients.
Pediatric use information is approved for Braintree Laboratories, Inc.'s SUPREPP® 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.
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 one dosage strength [see Dosage Forms and Strengths (3)] . The recommended dosage is:
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.
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:
Dose 2 - Day of Colonoscopy:
When diluted as directed, the solution is clear and colorless.
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 contraindicated in the following conditions:
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.
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.
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)] .
Use sodium sulfate, potassium sulfate, and magnesium sulfate oral solution with caution in patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs) [see Drug Interactions (7.1)] . These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration with sodium sulfate, potassium sulfate, and magnesium sulfate oral solution and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Use in Specific Populations (8.6)] .
Osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and sodium sulfate, potassium sulfate, and magnesium sulfate oral solution may increase these risks [see Drug Interactions (7.3)] . Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD).
If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering sodium sulfate, potassium sulfate, and magnesium sulfate oral solution [see Contraindications (4)] .
Use with caution in patients with severe active ulcerative colitis.
Patients with impaired gag reflex or other swallowing abnormalities are at risk for regurgitation or aspiration of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. Observe these patients during administration of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. Use with caution in these patients.
Serious hypersensitivity reactions, including anaphylaxis, angioedema, dyspnea, rash, pruritus and urticaria have been reported with sodium sulfate, potassium sulfate, and magnesium sulfate oral solution [see Adverse Reactions (6.2)]. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.
The following important adverse reactions for bowel preparations are described elsewhere in the labeling:
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.
| Split-Dose (2-Day) Regimen | ||
|---|---|---|
| Symptom | 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 |
* reported in at least 2% of patients
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.
| Day of Colonoscopy
N (%) † | Day 30
N (%) † | ||
|---|---|---|---|
| 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 sulfate oral solution | 27 (24) | 13 (12) |
| PEG + Electrolytes | 12 (10) | 20 (17) |
Less Common Adverse Reactions
AV Block (1 case) and CK increase.
Adverse Reactions with Unapproved Use
In another study of 408 adult patients, higher rates of the following adverse reactions and laboratory abnormalities were reported in patients treated with sodium sulfate, potassium sulfate, and magnesium sulfate oral solution as an evening-only (1-day) regimen compared to the split-dose (2-day) regimen.
Administration of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution in an evening-only (1-day) dosing regimen is not recommended.
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.
The following adverse reactions have been identified during post-approval use of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypersensitivity: anaphylaxis, angioedema, dyspnea, rash, pruritus, urticaria [see Warning and Precautions (5.8)].
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 )] .
Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution can reduce the absorption of other co-administered drugs [see Dosage and Administration (2.1)] .
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)] .
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 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.
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.
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.
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.
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)].
Use sodium sulfate, potassium sulfate, and magnesium sulfate oral solution with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after use of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions (5.4)] .
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.
Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution (for adults)is an osmotic laxative and is provided as two bottles each 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, grape flavor, malic acid, mixed berry flavor natural, purified water, sodium benzoate and sucralose.
| Sodium Sulfate, USP The chemical name is Na 2SO 4. The average Molecular Weight is 142.04. The structural formula is: | Potassium Sulfate, FCC, purified The chemical name is K 2SO 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 also contains a polypropylene mixing container.
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.
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.
No formal pharmacodynamic studies have been conducted with sodium sulfate, potassium sulfate, and magnesium sulfate oral solution.
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 maxwas 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.
The sulfate salts of sodium, potassium, and magnesium contained in sodium sulfate, potassium sulfate, and magnesium sulfate oral solution were administered orally (gavage) to rats and dogs up to 28 days up to a maximum daily dose of 5 grams/kg/day (approximately 0.9 and 3 times for rats and dogs, respectively, the recommended human dose of 44 grams/day or 0.89 grams/kg based on the body surface area). In rats, the sulfate salts caused diarrhea and electrolyte and metabolic changes, including hypochloremia, hypokalemia, hyponatremia, lower serum osmolality, and high serum bicarbonate. Significant renal changes included increased fractional sodium excretion, increased urinary sodium and potassium excretion, and alkaline urine in both males and females. In addition, creatinine clearance was significantly decreased in females at the highest dose. No microscopic renal changes were seen. In dogs, the sulfate salts caused emesis, excessive salivation, excessive drinking of water, and abnormal excreta (soft and/or mucoid feces and/or diarrhea) and increased urine pH and sodium excretion.
Adults
The colon cleansing efficacy of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution was evaluated in a randomized, single-blind, active-controlled, multicenter study in adult patients scheduled to have a colonoscopy. There were 363 adult patients included in the efficacy analysis. Patients ranged in age from 20 to 84 years (mean age 55 years) and 54% were female. Race distribution was 86% Caucasian, 9% African-American, and 5% other.
Patients were randomized to one of the following two colon preparation regimens: sodium sulfate, potassium sulfate, and magnesium sulfate oral solution or a marketed polyethylene glycol (PEG) plus electrolytes bowel preparation. In the Study sodium sulfate, potassium sulfate, and magnesium sulfate oral solution was administered as a split-dose (two-day) regimen. The PEG bowel prep was also given as a split-dose preparation according to its labeled instructions. Patients receiving sodium sulfate, potassium sulfate, and magnesium sulfate oral solution were limited to a light breakfast followed by clear liquids on the day prior to the day of colonoscopy; patients receiving the PEG bowel prep were allowed to have a normal breakfast and a light lunch, followed by clear liquids.
The primary efficacy endpoint was the proportion of patients with successful colon cleansing as assessed by the colonoscopists, who were not informed about the type of preparation received, as shown in Table 3. In the study, no clinically or statistically significant differences were seen between the group treated with sodium sulfate, potassium sulfate, and magnesium sulfate oral solution and the group treated with the PEG bowel prep.
| Treatment Group | Regimen | N | Responders
*
% (95% C. I.) | Sodium sulfate, potassium sulfate, and magnesium sulfate – PEG Difference
(95% CI) |
|---|---|---|---|---|
| Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution (with light breakfast) | Split-Dose | 180 | 97% (94%, 99%) | 2%† (-2%, 5%) |
| PEG bowel prep
(with normal breakfast & light lunch) | Split-Dose | 183 | 96% (92%, 98%) |
* Responders were patients whose colon preparations were graded excellent (no more than small bits of adherent feces/fluid) or good (small amounts of feces or fluid not interfering with the exam) by the colonoscopist.
† Does not equal difference in tabled responder rates due to rounding effects.
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.
Each Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution (for adults)(NDC 51672-4170-5) contains:
Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].
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.
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). Instruct patients or caregivers:
Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761
Dist. by:
Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
All trademarks are the property of their respective owners.
Revised: December 2025 5201578-1225-03
MEDICATION GUIDE Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate
|
| Read and understand this Medication Guide instructions 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:
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: o vomiting o urinating less often than normal
|
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 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.
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Do not take sodium sulfate, potassium sulfate, and magnesium sulfate oral solution if your healthcare provider has told you that you have:
<"background-color: transparent;">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).
• are breastfeeding or plan to breastfeed. It is not known if sodium sulfate, potassium sulfate, and magnesium sulfate oral solution passes into your breast milk. You and your healthcare provider should decide if you will take sodium sulfate, potassium sulfate, and magnesium sulfate oral solution while breastfeeding.
Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of each dose of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. Especially tell your healthcare provider if you take: The following medicines should be taken at least 2 hours before starting sodium sulfate, potassium sulfate, and magnesium sulfate oral solution and not less than 6 hours after taking sodium sulfate, potassium sulfate, and magnesium sulfate oral solution:
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. |
How should I take sodium sulfate, potassium sulfate, and magnesium sulfate oral solution? See the Instructions for Use in the dosing instructions. You must read, understand, and follow these instructions to take sodium sulfate, potassium sulfate, and magnesium sulfate oral solution the right way. • Take sodium sulfate, potassium sulfate, and magnesium sulfate oral solution exactly as your healthcare provider tells you to take it.
• While taking sodium sulfate, potassium sulfate, and magnesium sulfate oral solution, do not: • take any other laxatives.
|
What are the possible side effects of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution? Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution can cause serious side effects, including: • See
What is the most important information I should know about sodium sulfate, potassium sulfate, and magnesium sulfate oral solution?
o difficulty breathing o itching o swelling of the face, lips, tongue or throat o raised red patches on your skin (hives) o skin rash The most common side effects of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution in adults include: o overall discomfort o stomach bloating
These are not all the possible side effects of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
How should I store sodium sulfate, potassium sulfate, and magnesium sulfate oral solution? • Store sodium sulfate, potassium sulfate, and magnesium sulfate oral solution at room temperature, between 68°F to 77°F (20°C to 25°C). Keep sodium sulfate, potassium sulfate, and magnesium sulfate oral solution and all medicines out of the reach of children. |
General information about the safe and effective use of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sodium sulfate, potassium sulfate, and magnesium sulfate oral solution for a condition for which it was not prescribed. Do not give sodium sulfate, potassium sulfate, and magnesium sulfate oral solution to other people, even if they are going to have the same procedure you are. It may harm them. You can ask your pharmacist or healthcare provider for information about sodium sulfate, potassium sulfate, and magnesium sulfate oral solution that is written for health professionals. |
What are the ingredients in sodium sulfate, potassium sulfate, and magnesium sulfate oral solution? Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution is supplied in one dosage strength. Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution comes in a carton containing two 6-ounce bottles, along with a 16-ounce polypropylene mixing container. Each bottle contains:
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. Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761
|
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: December 2025 5201578-1225-03
 |  | ||
| Pour ONE (1) 6-ounce bottle of Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate liquid into the mixing container. | Add cool drinking water to the 16-ounce line on the container and mix. | ||
 |  | ||
| Drink ALL the liquid in the container. | You must drink two (2) more 16-ounce containers of water over the next 1 hour. |
NDC 51672-4170-5
Sodium Sulfate,
Potassium Sulfate, and
Magnesium Sulfate
Oral Solution
For Adults
(17.5 g/3.13 g/1.6 g) per 6 ounces
Bowel Prep Kit
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1001689 | {2 (480 ML) (magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution) } Pack | GPCK | 10 |
| 1001689 | 2 (16 OZ magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM Oral Solution) Pack | PSN | 10 |
| 1120068 | magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM in 177 mL Oral Solution | PSN | 10 |
| 1120068 | magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution | SCD | 10 |
| 1120068 | Magnesium Sulfate 0.0277 MEQ/ML / K+ sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution | SY | 10 |
| 1120068 | Magnesium Sulfate 0.0277 MEQ/ML / Pot sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution | SY | 10 |
| 1120068 | magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM per 177 ML Oral Solution | SY | 10 |
| Class | Version | Type | Effective |
|---|---|---|---|
| MAGNESIUM CATION Pharmacologic Class Indexing | 4 | Indexing - Pharmacologic Class | 20180813 |
| SULFATE ION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0351672417055 | GTIN-13: 0351672417055 EAN-13: 0351672417055 GTIN-12: 351672417055 UPC-A: 351672417055 GTIN storage (14 digits): 00351672417055 | RX5201059C177-SUN25.jpg |
| Data code | Data Matrix | 12345678910 | RX5201059C177-SUN25.jpg, RX520105903C177TARO18A.jpg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51672-4170-5 | Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit | 2 in 1 CARTON | SOLUTION | 2 | 10 | |
| 51672-4170-5 | Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit | 177 mL in 1 BOTTLE | SOLUTION | 177 | 10 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51672-4170-5 | ML - Milliliter | 51672-4170 | 089930b7-eef0-42d2-8fc6-043d5d156d6e | 1 | 2024-06-10 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51672-4170 | 51672-4170-5 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| MALIC ACID | 817L1N4CKP | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SODIUM SULFATE ANHYDROUS | 36KCS0R750 | ACTIR |
| POTASSIUM SULFATE | 1K573LC5TV | ACTIB |
| MAGNESIUM SULFATE, UNSPECIFIED FORM | DE08037SAB | ACTIB |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206431-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 |
| Application-product | TE code |
|---|---|
| A206431-001 | AA |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A206431-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A206431-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206431-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206431-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206431-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206431-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206431-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206431-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206431-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206431-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206431-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A206431-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206431-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206431-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206431-001 | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A206431-001 | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | 8072bd15b7f6… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206431-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION / ORAL | AA | 2024-03-19 | a50c72e98297… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A206431-001 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A206431-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A206431-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206431-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206431-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206431-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206431-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206431-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206431-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206431-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206431-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A206431-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206431-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206431-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206431-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A206431-001 | AA | 1 | 8072bd15b7f6… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206431-001 | AA | 1 | a50c72e98297… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit | SODIUM SULFATE ANHYDROUS, POTASSIUM SULFATE, AND MAGNESIUM SULFATE | Sun Pharmaceutical Industries, Inc. | 4adeeb11-0f3a-47d8-a664-376df50b05f2 | 2025-12-31 | Warnings, Adverse reactions | 51672-4170-5 51672-4170 51672417005 494f52da-8ae6-6ec4-e063-6294a90a73a6 4adeeb11-0f3a-47d8-a664-376df50b05f2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.