Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate is an FDA-registered drug product whose active ingredient is SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE. It is labelled by Ascend Laboratories, LLC taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 67877-725, application ANDA213924, label effective 20260808. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE are most often described in connection with: sodium sulfate, oral solution, colon preparation, colonoscopy adult, braintree laboratories, indications usage, patients pediatric, information approved. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS & USAGE Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult patients. Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adult patients. ( 1 )

2 DOSAGE AND ADMINISTRATION Preparation and Administration ( 2.2 ) Must dilute in water prior to ingestion. Administration of two bottles of sodium sulfate, potassium sulfate and magnesium sulfate oral solution is required for a complete preparation for colonoscopy. One bottle is equivalent to one dose. Must consume additional water after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy. Recommended Dosage and Administration Split-Dose (two-day) regimen consists of two doses of sodium sulfate, potassium sulfate and magnesium sulfate oral solution: first dose during the evening prior to colonoscopy and second dose the next day, during the morning of colonoscopy. ( 2.1 , 2.3 ) Recommended sodium sulfate, potassium sulfate and magnesium sulfate oral solution dosage is: o Adults: Two 6-ounce doses. ( 2.3 ) For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing Information. ( 2.1 , 2.2 , 2.3 ) 2.1 Dosage and Administration Overview Administration of two bottles of sodium sulfate, potassium sulfate and magnesium sulfate oral solution and additional water is required for a complete 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: Adults: Two 6-ounce doses [see Dosage and Administration ( 2.3 )] . 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. 2.2 Important 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. 2.3 Recommended Dosage and Administration in 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 the evening before the procedure, pour the contents of one bottle of sodium sulfate, potassium sulfate and magnesium sulfate oral solution into the mixing container provided. Add cool drinking water to the 16-ounce fill line on the container, mix, and drink the entire amount. Drink two additional containers filled with water to the 16-ounce fill line over the next hour. Dose 2 - Day of Colonoscopy: Continue to consume only clear liquids. In the morning (10 to 12 hours after the evening dose) on the day of the procedure, pour the contents of the second bottle of sodium sulfate, potassium sulfate and magnesium sulfate oral solution into the mixing container provided. Add cool drinking water to the 16-ounce fill line on the container, mix, and drink the entire amount. Drink two additional containers filled with water to the 16-ounce fill line over the next hour. Complete all solution of sodium sulfate, potassium sulfate and magnesium sulfate oral solution and required water at least two hours prior to colonoscopy.

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 )

6 ADVERSE REACTIONS The following important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Serum Chemistry Abnormalities [see Warnings and Precautions ( 5.1 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] Seizures [see Warnings and Precautions ( 5.3 )] Use in Patients with Risk of Renal Injury [see Warnings and Precautions ( 5.4 )] Colonic Mucosal Ulceration and Ischemic Colitis [see Warnings and Precautions ( 5.5 )] Patients with Significant Gastrointestinal Disease [see Warnings and Precautions ( 5.6 )] Aspiration [see Warnings and Precautions ( 5.7 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] Most common adverse reactions are: Adults (>2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. 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 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 * 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. 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 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 sulfate oral solution 27 (24) 13 (12) PEG + Electrolytes 12 (10) 20 (17) 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 timepoint(s) of interest. 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. overall discomfort, abdominal distention, nausea, and vomiting total bilirubin (high), BUN (high), creatinine (high), osmolality (high), potassium (high) and uric acid (high) 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. 6.2 Postmarketing Experience 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 )]

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate used for?
1 INDICATIONS & USAGE Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult patients. Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, …

Who makes Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate?
Ascend Laboratories, LLC is the labeler of record for Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate.

What form does Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.