SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

Warnings and Precautions, Hypersensitivity Reactions ( 5.8 ) 11/2025

1 INDICATIONS AND USAGE Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adult and pediatric patients 12 years of age and older. ( 1 )

2 DOSAGE AND ADMINISTRATION Preparation and Administration ( 2.2 ) Must dilute in water prior to ingestion. Administration of two bottles of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is required for a complete preparation for colonoscopy. One bottle is equivalent to one dose. Must consume additional water after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy. Recommended Dosage and Administration Split-Dose (two-day) regimen consists of two doses of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution: first dose during the evening prior to colonoscopy and second dose the next day, during the morning of colonoscopy. ( 2.1 , 2.3 , 2.4 ) Recommended Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution dosage is: Adults: Two 6-ounce doses. ( 2.3 ) Pediatric Patients 12 Years of Age and Older: Two 4.5-ounce doses. ( 2.4 ) For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing Information. ( 2.1 , 2.2 , 2.3 , 2.4 ) 2.1 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 two dosage strengths [see Dosage Forms and Strengths ( 3 )] . The recommended dosage is: Adults: Two 6-ounce doses [see Dosage and Administration ( 2.3 )]. Pediatric patients 12 years of age and older: Two 4.5-ounce doses [see Dosage and Administration ( 2.4 )]. 2.2 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 for Adults The recommended Split-Dose (two-day) regimen for adults consists of two 6-ounce doses of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution: the first dose during the evening prior to colonoscopy and the second dose the next day, during the morning of the colonoscopy. Each dose consists of one bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution with additional water. The total volume of liquid required for colon cleansing (using two bottles) is 3 quarts. The following are recommended dosage and administration instructions for adults: Dose 1 – On the Day Prior to Colonoscopy: May consume a light breakfast, or only clear liquids …

3 DOSAGE FORMS AND STRENGTHS Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for adults) : Two bottles each containing 6 ounces of an oral solution of 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate as a clear to slightly hazy liquid. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for pediatric patients 12 years of age and older) : Two bottles each containing 4.5 ounces of an oral solution of 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate as a clear to slightly hazy liquid. When diluted as directed, the solution is clear and colorless. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for adults) : Two bottles each containing 6 ounces of an oral solution of 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. ( 3 ) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for pediatric patients 12 years of age and older) : Two bottles each containing 4.5-ounces of an oral solution of 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate. ( 3 )

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 Precautions ( 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 Most common adverse reactions are: Adults (>2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting. ( 6.1 ) Pediatric Patients (>10%): nausea, abdominal pain, abdominal bloating and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The following important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Serum Chemistry Abnormalities [see Warnings and Precautions ( 5.1 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] Seizures [see Warnings and Precautions ( 5.3 )] Use in Patients with Risk of Renal Injury [see Warnings and Precautions ( 5.4 )] Colonic Mucosal Ulceration and Ischemic Colitis [see Warnings and Precautions ( 5.5 )] Patients with Significant Gastrointestinal Disease [see Warnings and Precautions ( 5.6 )] Aspiration [see Warnings and Precautions ( 5.7 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. Adults The safety of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was evaluated in a multi-center, randomized, active controlled trial in 379 adult patients undergoing colonoscopy [see Clinical Studies ( 14 )] . Most Common Adverse Reactions Table 1 shows the most common adverse reactions reported in at least 2% of patients receiving Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution or the control (a bowel prep containing polyethylene glycol and electrolytes (PEG + E)) administered in split-dose (2-day) regimens. Table 1: Common Adverse Reactions* in Adult Patients Undergoing Colonoscopy in a Randomized, Active Controlled Trial 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 wher …

7 DRUG INTERACTIONS Drugs that increase risk of fluid and electrolyte imbalance. ( 7.1 ) 7.1 Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities Use caution when prescribing Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution to patients taking medications that increase the risk of fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 )]. 7.2 Potential for Reduced Drug Absorption Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution can reduce the absorption of other co-administered drugs [see Dosage and Administration ( 2.1 )] . Administer oral medications at least one hour before starting each dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution to avoid chelation with magnesium. 7.3 Stimulant Laxatives Concurrent use of stimulant laxatives and Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution [see Warnings and Precautions ( 5.5 )] .

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 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. 8.2 Lactation Risk Summary There are no data available data on the presence of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in human or animal milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and any potential adverse effects on the breastfed child from Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses) have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 12 years of age and older. Use of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in this age group is supported by evidence from an adequate and well-controlled trial of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in adults and a single, dose-ranging, controlled trial in 89 pediatric patients 12 years to 16 years of age [see Clinical Studies ( 14 )] . In the pediatric trial, Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 6-ounce doses) did not demonstrate additional treatment benefit and more patients reported gastrointestinal adverse reactions compared to Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses). Therefore, Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 6-ounce doses) is not recommended for pediatric patients 12 years of age and older [see Dosage and Administration ( 2.3 )] . The safety profile of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses) in this pediatric population was similar to that seen in adults [see Adverse Reactions ( 6.1 )] . The safety and effectiveness of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in pediatric patients less than 12 years of age have not been established. 8.5 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 the recommended split-dose (2-day) regimen, were observed between geriatric patients and younger patients. Geriatric patients reported more vomiting when Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was given as a one-day preparation (not a recommended regimen). Elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1 )] . 8.6 Renal Impairment Use Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution with caution in patients with renal i …

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.

11 DESCRIPTION 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 USP, flavoring ingredients, malic acid FCC, sodium benzoate, NF, sucralose, purified water, USP. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for pediatric patients 12 years of age and older) is an osmotic laxative and is provided as two bottles each containing 4.5 ounces of solution. Each bottle contains: 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate. Inactive ingredients include: citric acid USP, flavoring ingredients, malic acid FCC, sodium benzoate, NF, sucralose, purified water, USP. Sodium Sulfate, USP The chemical name is Na 2 SO 4 . The average Molecular Weight is 142.04. The structural formula is: Potassium Sulfate, FCC, purified The chemical name is K 2 SO 4 . The average Molecular Weight is 174.26. The structural formula is: Magnesium Sulfate, USP The chemical name is MgSO 4 . The average Molecular Weight: 120.37. The structural formula is: Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution also contains a polypropylene mixing container. sod sulfate pot sulfate mg sulfate

10 OVERDOSAGE Overdosage of more than the recommended dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution may lead to severe electrolyte disturbances, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances. [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) ] . Monitor for fluid and electrolyte disturbances and treat symptomatically.

16 HOW SUPPLIED/STORAGE AND HANDLING Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for adults) (NDC 10572-012-01) contains: Two bottles (NDC 10572-011-01) 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. Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for pediatric patients 12 years of age and older) (NDC 10572-112-01) contains: Two bottles (NDC 10572-111-01) each containing 4.5-ounces of an oral solution of 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 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 12-ounce fill line. Store at 20° to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F). See USP controlled room temperature.