Medicine guide

Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate

17.5 g/177mL + 3.13 g/177mL + 1.6 g/177mL · Solution

Prescription only
Calculi Dissolution Agent

Active substance: Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate
Used in: Digestion, stomach, diabetes and nutrition
Made by: Lupin Pharmaceuticals, Inc.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-12-15

What it is

Calculi Dissolution Agent

Used for

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in

Do not take it if

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

9other products contain Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

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 )

From the official label · 2025-12-15 · DailyMed

How it works

From this product’s own US prescribing label.

12 CLINICAL PHARMACOLOGY 12.1 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. 12.2 Pharmacodynamics The osmotic effect of the unabsorbed ions, when ingested with a large volume of water, produces a copious watery diarrhea. 12.3 Pharmacokinetics Fecal excretion was the primary route of sulfate elimination.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-12-15

Do not take it if

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 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

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 laboratory tests (electrolytes, creatinine, and BUN) in these patients.
5.5 Colonic Mucosal Ulcerations and Ischemic Colitis Administration of 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.
The potential for mucosal ulcerations resulting from the bowel preparation should be considered when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD).
5.6 Use in Patients with Significant Gastrointestinal Disease 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.
Use with caution in patients with severe active ulcerative colitis.
5.7 Aspiration Use with caution in patients with impaired gag reflex and patients prone to regurgitation or aspiration.
Such patients should be observed during administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.
5.8 Not for Direct Ingestion Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance.
Direct ingestion of the undiluted solution may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

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.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

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.

Quoted from the official label, section “Drug Interactions”.

Side effects

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 patients with normal baseline who had abnormal values at the timepoint(s) of interest. †Patients with normal bicarbonate at baseline who developed low bicarbonate (≤ 21 mEq/L) and high anion gap (≥ 13 mEq/L) on Day of Colonoscopy or Day 30.
There were also 408 patients who participated in a study in which either Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution or PEG+E were administered in an evening-only (1-day) regimen.
Higher rates of overall discomfort, abdominal distention, and nausea were observed with the evening-only (1-day) regimen compared to the split-dose (2-day) regimen for both preparations.
Patients treated with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution had increased rates of vomiting with the evening-only (1-day) regimen.
An evening-only (1-day) dosing regimen was associated with higher rates of abnormal values for some electrolytes when compared to the split-dose (2-day) regimen for both preparations.
For Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, the evening-only (1-day) regimen was associated with higher rates of total bilirubin (high), BUN (high), creatinine (high), osmolality (high), potassium (high) and uric acid (high) than the Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

See Medication Guide and FDA -Approved Patient Labeling 17.1 Patient Counseling
Ask patients to let you know if they have trouble swallowing or are prone to regurgitation or aspiration.
Instruct patients that each bottle needs to be diluted in water before ingestion and that they need to drink additional water according to the instructions. Direct ingestion of the undiluted solution may increase the risk of nausea, vomiting, and dehydration.
Inform patients that oral medications may not be absorbed properly if they are taken within one hour of starting each dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.
Tell patients not to take other laxatives while they are taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc. Lupin Pharmaceuticals, Inc. Naple, FL 34018 SAP Code:
276530 Revised 10/2024

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS & STRENGTHS 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.
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 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

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

Quoted from the official label, section “How Supplied”.

What is in it

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. figure-01 figure-02 figure-03

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (5)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 5 of 5

Details

Made by	Lupin Pharmaceuticals, Inc.
Active substance	Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate
Used in	Digestion, stomach, diabetes and nutrition
Strength	17.5 g/177mL + 3.13 g/177mL + 1.6 g/177mL
Form	Solution
Route	Oral
Packs	2 BOTTLE in 1 CARTON / 177 mL in 1 BOTTLE
NDC	43386-700

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Solution2 products
- 17.5 g/177mL + 3.13 g/177mL + 1.6 g/177mL2
  17.5 g/177mL + 3.13 g/177mL + 1.6 g/177mL · 2 companies
  - Lupin Pharmaceuticals, Inc. · this page
  - Novel Laboratories, Inc.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate