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sodium sulfate, potassium sulfate, magnesium sulfate
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Calculi Dissolution Agent [EPC] | EPC | All 33 members |
| Increased Large Intestinal Motility [PE] | PE | All 83 members |
| Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] | PE | All 83 members |
| Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] | PE | All 30 members |
| Magnesium Ion Exchange Activity [MoA] | MoA | All 30 members |
| Osmotic Activity [MoA] | MoA | All 105 members |
| Osmotic Laxative [EPC] | EPC | All 103 members |
| Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] | PE | All 53 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 202511-001 | SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | SOLUTION | MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | Prescription | AA |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — no known or suspected bioequivalence problems (conventional dosage forms)
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | February 23, 2017 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251215). This is the manufacturer's labelling text, not a summary and not advice.
Recent Major Changes
openFDA Drug LabelingRECENT MAJOR CHANGES Dosage and Administration 11/2012 Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA PI7000000103 Revised 11/2014
Indications and Usage
openFDA Drug Labeling1 INDICATIONS & USAGE Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults ( 1 )
Dosage and Administration
openFDA Drug Labeling2 DOSAGE & ADMINISTRATION Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution should be taken as a split-dose oral regimen. The dose for colon cleansing requires administration of two bottles of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Each bottle is administered as 16 ounces of diluted Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution with an additional 1 quart of water taken orally. The total volume of liquid required for colon cleansing (using two bottles) is 3 quarts (approximately 2.8 L) taken orally prior to the colonoscopy in the following way: Split-Dose (Two-Day) Regimen Day prior to colonoscopy: A light breakfast may be consumed, or have only clear liquids on the day before colonoscopy. Avoid red and purple liquids, milk, and alcoholic beverages. Early in the evening prior to colonoscopy: pour the contents of one bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution into the mixing container provided. Fill the container with water to the 16 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour. Day of colonoscopy: Have only clear liquids until after the colonoscopy. Avoid red and purple liquids, milk, and alcoholic beverages. The morning of colonoscopy (10 to 12 hours after the evening dose): pour the contents of the second bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution into the mixing container provided. Fill the container with water to the 16 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour. Complete all Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and required water at least two hours prior to colonoscopy or as directed by physician. Dilute the solution prior to use. See FULL PRESCRIBING INFORMATION for complete dosing and administration instructions ( 2 ) Split Dose (2-Day) Regimen Evening before colonoscopy: dilute one bottle with water to a total volume of 16 ounces (up to the fill line) and drink the entire amount. Drink 32 ounces of water over the next hour. Next morning: repeat both steps using the second bottle. Complete preparation at least 2 hours before colonoscopy or as directed by physician.
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS & STRENGTHS Two 6 ounce bottles of oral solution, each containing sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, and magnesium sulfate 1.6 grams. ( 3 ) • Two 6 ounce bottles of oral solution. Each 6 ounce bottle contains: sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, magnesium sulfate 1.6 grams.
Contraindications
openFDA Drug Labeling4 CONTRAINDICATIONS Gastrointestinal obstruction Bowel perforation Gastric retention Ileus Toxic colitis or toxic megacolon Known allergies to components of the kit [see Description (11) ] Gastrointestinal obstruction ( 4 , 5.6 ) Bowel perforation ( 4 , 5.6 ) Gastric retention ( 4 ) Ileus ( 4 ) Toxic colitis or toxic megacolon ( 4 ) Known allergies to components of the kit ( 4 , 11 )
Warnings and Cautions
openFDA Drug Labeling5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment– assess concurrent medications and consider testing in some patients ( 5.1 , 5.2 , 5.3 ) Patients with renal insufficiency– use caution, ensure adequate hydration and consider testing ( 5.4 ) Suspected GI obstruction or perforation – rule out the diagnosis before administration ( 4 , 5.6 ) Patients at risk for aspiration – observe during administration ( 5.7 ) Not for direct ingestion – dilute and take with additional water ( 5.8 ) 5.1 Serious 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. Patients with electrolyte abnormalities should have them corrected before treatment with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. In addition, use caution when prescribing Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution for 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. 5.2 Cardiac 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). Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias. 5.3 Seizures 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. 5.4 Renal Impairment Use caution when prescribing Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution for 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). Advise these patients of the importance of adequate hydration, and consider performing baseline and post-colonoscopy lab …
Adverse Reactions
openFDA Drug Labeling6 ADVERSE REACTIONS Most common adverse reactions (≥3%) are: overall discomfort, abdominal fullness, nausea, abdominal cramping, and vomiting ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-866-403-7592 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. In a multicenter, controlled clinical trial comparing Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution with a bowel prep containing polyethylene glycol and electrolytes (PEG + E) that were administered in a split-dose (2-day) regimen, the most common adverse reactions after administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution were overall discomfort, abdominal distention, abdominal pain, nausea, vomiting, and headache; see Table 1, below. Less common Adverse Reactions occurring were AV Block (1 case) and CK increase. In this study, patients receiving Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution were limited to a light breakfast followed by clear liquids; patients receiving the PEG + E bowel prep were allowed to have a normal breakfast and a light lunch, followed by clear liquids. Table 1: Treatment-Emergent Adverse Reactions Observed in at Least 2% of Patients on the Split-Dose (2-Day) Regimen Symptom Split-Dose (2-Day) Regimen Sodium Sulfate, Potassium Sulfate and MagnesiumSulfate Oral SolutionN=190 PEG + EProductN=189 Overall Discomfort 54% 67% Abdominal Distension 40% 52% Abdominal Pain 36% 43% Nausea 36% 33% Vomiting 8% 4% Headache 1.1% 0.5% Table 2 shows the percentages of 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: Patients with Normal Baseline Serum Chemistry with A Shift to an Abnormal Value While on the Split-Dose (2-Day) Regimen Day of Colonoscopy n (%)* Day 30 n (%)* Anion gap (high) † Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 14 (8.9) 3 (1.9) PEG + Electrolytes 12 (7.6) 2 (1.4) Bicarbonate (low) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 20 (12.7) 7 (4.4) PEG + Electrolytes 24 (15.2) 4 (2.7) Bilirubin, total (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 14 (8.5) 0 (0) PEG + Electrolytes 20 (11.7) 3 (1.9) BUN (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 2 (1.6) 14 (11.2) PEG + Electrolytes 4 (2.9) 19 (14.5) Calcium (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 16 (10.4) 8 (5.2) PEG + Electrolytes 6 (3.7) 6 (3.9) Chloride (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 4 (2.4) 6 (3.7) PEG + Electrolytes 20 (12.2) 6 (3.8) Creatinine (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 3 (1.9) 5 (3.2) PEG + Electrolytes 2 (1.2) 8 (5.2) Osmolality (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 8 (5.8) NA PEG + Electrolytes 19 (12.9) NA Osmolality (low) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 3 (2.2) NA PEG + Electrolytes 2 (1.4) NA Potassium (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 3 (1.8) 6 (3.7) PEG + Electrolytes 5 (2.9) 8 (4.9) Sodium (low) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 5 (3.1) 1 (0.6) PEG + Electrolytes 4 (2.3) 2 (1.2) Uric acid (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 27 (23.5) 13 (11.5) PEG + Electrolytes 12 (9.5) 20 (16.7) *Percent (n/N) of patients where N=number of patie …
Drug Interactions
openFDA Drug Labeling7 DRUG INTERACTIONS Some drugs increase risks due to fluid and electrolyte changes ( 7.1 ) Oral medication taken within 1 hour of start of each dose might not be absorbed properly ( 7.2 ) 7.1 Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities Use caution when prescribing Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution for 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 prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate [see Warnings (5) ] in patients taking these concomitant medications. 7.2 Potential for Altered Drug Absorption Oral medication administered within one hour of the start of each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution dose may be flushed from the gastrointestinal tract, and the medication may not be absorbed properly.
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. It is also not known whether Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution should be given to a pregnant woman only if clearly needed. 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric 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 a 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.
Mechanism of Action
openFDA Drug Labeling12.1 Mechanism 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.
Description
openFDA Drug Labeling11 DESCRIPTION Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution contains two 6 ounce bottles of solution. Each 6 ounce bottle contains: sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, magnesium sulfate 1.6 grams. Inactive ingredients include: sodium benzoate, sucralose, malic acid, citric acid, lemon flavor, purified water. The solution is a clear to slightly hazy liquid. The solution is clear and colorless when diluted to a final volume of 16 ounces with water. 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, Granular 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. Structural Formula Figure 39b225fe-figure-03
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution contains: • Two (2) 6 ounce bottles of oral solution. • One (1) 19 ounce mixing container with a 16 ounce fill line. Storage: Store at 20o to 25°C (68o to 77°F). Excursions permitted between 15o to 30°C (59o to 86°F). See USP controlled room temperature. Keep out of reach of children. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution Package NDC 43386-700-83
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: MAGNESIUM SULFATE ANHYDROUS. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 43386-700-83 | 43386-700 | Lupin Pharmaceuticals, Inc. | 2 BOTTLE in 1 CARTON (43386-700-83) / 177 mL in 1 BOTTLE | December 30, 2022 |
| 40032-700-83 | 40032-700 | Novel Laboratories, Inc. | 2 BOTTLE in 1 CARTON (40032-700-83) / 177 mL in 1 BOTTLE | February 23, 2017 |
| 43386-700 | 43386-700 | Lupin Pharmaceuticals, Inc. | — | December 30, 2022 |
| 40032-700 | 40032-700 | Novel Laboratories, Inc. | — | February 23, 2017 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.