These Highlights Do Not Include All The Information Needed To Use Sodium Sulfate, Potassium Sulfate, And Magnesium Sulfate Oral Solution Safely And Effectively. See Full Prescribing Information For Sodium Sulfate, Potassium Sulfate, And Magnesium Sulfate Oral Solution.

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)] .

Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature].

Keep out of reach of children.

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.

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)] .

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, USP, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate, USP. Inactive ingredients include: citric acid anhydrous, malic acid, natural and artificial blueberry flavor, purified water, sodium benzoate, and sucralose.

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.

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)].

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

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)]

Drugs that increase risk of fluid and electrolyte imbalance. ( 7.1)

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.

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)] .

On the day before your procedure

• You may have a light breakfast or have clear liquids ONLY; please have nothing for dinner

• DO NOTdrink milk

• DO NOTeat or drink anything colored red or purple

• DO NOTdrink alcoholic beverages

Any of the following clear liquids are OK

Water

Strained fruit juices (without pulp) including apple, orange, white grape, or white cranberry

Limeade or lemonade

Coffee or tea ( DO NOTuse any dairy or non-dairy creamer)

Chicken broth

Gelatin desserts without added fruit or topping ( NO RED OR PURPLE)

Your doctor has recommended split-dose sodium sulfate, potassium sulfate, and magnesium sulfate oral solution

(Both 6-ounce bottles are required for a complete prep.)

Pour ONE (1) 6-ounce bottle of prep 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 mustdrink two (2) more 16-ounce containers of water over the next 1 hour.

No formal pharmacodynamic studies have been conducted with sodium sulfate, potassium sulfate, and magnesium sulfate oral solution.

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.

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.

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)] .

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.

• Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after each use. ( 5.1, 7.1)
• Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. ( 5.2)
• Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold. ( 5.3, 7.1)
• Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing. ( 5.4, 7.1)
• Suspected GI obstruction or perforation: Rule out the diagnosis before administration. ( 4, 5.6)
• Patients at risk for aspiration: Observe during administration. ( 5.7)

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:
  • 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)

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, USP, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate, USP as a clear to slightly hazy liquid.

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.

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.

NDC 69452-428-97

Sodium Sulfate, Potassium Sulfate, and Magsium Sulfate Oral Solution

For Adults

(17.5g/3.13g/1.6g) per 6 ounces

Dispense the enclosed Medication Guide to each patient.

Rx only

This bottle contains 6 ounces (177 mL) of liquid bowel prep

For India Manufacturing site:

NDC 69452-428-62

Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution

For Adults

(17.5g/3.13g/1.6g) per 6 ounces

Dispense the enclosed Medication Guide to each patient.

Rx only

This carton contains:

2 6-ounce (177 mL) bottles of liquid bowel prep

1 16-ounce mixing container

1 Patient booklet. Booklet includes:1 - Medication Guide

2 - Patient Instructions

3 - Full Prescribing Information

Dilute the solution concentrate as directed prior to use.

Both 6-ounce bottles are required for a complete prep.

Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature].

For India Manufacturing Site:

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide).

Instruct patients or caregivers:

• Must dilute sodium sulfate, potassium sulfate, and magnesium sulfate oral solution 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, apple or orange juice without pulp, lemonade, coffee, tea, or chicken broth). On the day of the colonoscopy only consume clear liquids up to two hours prior to colonoscopy.
• Two doses of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution are required for a complete preparation for colonoscopy .One bottle of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution is equivalent to one dose.
• Do not take other laxatives while taking sodium sulfate, potassium sulfate, and magnesium sulfate oral solution.
• Do not eat solid food or drink milk or eat or drink anything colored red or purple.
• Do not drink alcohol.
• 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 colonoscopy.
• Contact their healthcare provider if they develop significant vomiting or signs of dehydration after taking sodium sulfate, potassium sulfate, and magnesium sulfate oral solution or if they experience cardiac arrhythmias or seizures [see Warnings and Precautions (5.1, 5.2, 5.3)] .

Each sodium sulfate, potassium sulfate, and magnesium sulfate oral solution kit (for adults)(NDC 69452-428-62) contains:

• Two bottles each containing 6-ounces of an oral solution of 17.5 grams sodium sulfate, USP, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate, USP as a clear to slightly hazy liquid. When diluted as directed, the solution is clear and colorless.
• One (1) 20-ounce mixing container with a 16-ounce fill line.

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.

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.

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 time 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.

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)] .

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.

The recommended Split-Dose (two-day) regimen for adultsconsists 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 hours 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.

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).

• 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.

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.

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)] .

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)] .

Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature].

Keep out of reach of children.

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.

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)] .

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, USP, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate, USP. Inactive ingredients include: citric acid anhydrous, malic acid, natural and artificial blueberry flavor, purified water, sodium benzoate, and sucralose.

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.

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)].

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

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)]

Drugs that increase risk of fluid and electrolyte imbalance. ( 7.1)

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.

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)] .

On the day before your procedure

• You may have a light breakfast or have clear liquids ONLY; please have nothing for dinner

• DO NOTdrink milk

• DO NOTeat or drink anything colored red or purple

• DO NOTdrink alcoholic beverages

Any of the following clear liquids are OK

Water

Strained fruit juices (without pulp) including apple, orange, white grape, or white cranberry

Limeade or lemonade

Coffee or tea ( DO NOTuse any dairy or non-dairy creamer)

Chicken broth

Gelatin desserts without added fruit or topping ( NO RED OR PURPLE)

Your doctor has recommended split-dose sodium sulfate, potassium sulfate, and magnesium sulfate oral solution

(Both 6-ounce bottles are required for a complete prep.)

Pour ONE (1) 6-ounce bottle of prep 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 mustdrink two (2) more 16-ounce containers of water over the next 1 hour.

No formal pharmacodynamic studies have been conducted with sodium sulfate, potassium sulfate, and magnesium sulfate oral solution.

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.

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.

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)] .

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.

• Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after each use. ( 5.1, 7.1)
• Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. ( 5.2)
• Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold. ( 5.3, 7.1)
• Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing. ( 5.4, 7.1)
• Suspected GI obstruction or perforation: Rule out the diagnosis before administration. ( 4, 5.6)
• Patients at risk for aspiration: Observe during administration. ( 5.7)

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:
  • 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)

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, USP, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate, USP as a clear to slightly hazy liquid.

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.

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.

NDC 69452-428-97

Sodium Sulfate, Potassium Sulfate, and Magsium Sulfate Oral Solution

For Adults

(17.5g/3.13g/1.6g) per 6 ounces

Dispense the enclosed Medication Guide to each patient.

Rx only

This bottle contains 6 ounces (177 mL) of liquid bowel prep

For India Manufacturing site:

NDC 69452-428-62

Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Oral Solution

For Adults

(17.5g/3.13g/1.6g) per 6 ounces

Dispense the enclosed Medication Guide to each patient.

Rx only

This carton contains:

2 6-ounce (177 mL) bottles of liquid bowel prep

1 16-ounce mixing container

1 Patient booklet. Booklet includes:1 - Medication Guide

2 - Patient Instructions

3 - Full Prescribing Information

Dilute the solution concentrate as directed prior to use.

Both 6-ounce bottles are required for a complete prep.

Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature].

For India Manufacturing Site:

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide).

Instruct patients or caregivers:

• Must dilute sodium sulfate, potassium sulfate, and magnesium sulfate oral solution 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, apple or orange juice without pulp, lemonade, coffee, tea, or chicken broth). On the day of the colonoscopy only consume clear liquids up to two hours prior to colonoscopy.
• Two doses of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution are required for a complete preparation for colonoscopy .One bottle of sodium sulfate, potassium sulfate, and magnesium sulfate oral solution is equivalent to one dose.
• Do not take other laxatives while taking sodium sulfate, potassium sulfate, and magnesium sulfate oral solution.
• Do not eat solid food or drink milk or eat or drink anything colored red or purple.
• Do not drink alcohol.
• 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 colonoscopy.
• Contact their healthcare provider if they develop significant vomiting or signs of dehydration after taking sodium sulfate, potassium sulfate, and magnesium sulfate oral solution or if they experience cardiac arrhythmias or seizures [see Warnings and Precautions (5.1, 5.2, 5.3)] .

Each sodium sulfate, potassium sulfate, and magnesium sulfate oral solution kit (for adults)(NDC 69452-428-62) contains:

• Two bottles each containing 6-ounces of an oral solution of 17.5 grams sodium sulfate, USP, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate, USP as a clear to slightly hazy liquid. When diluted as directed, the solution is clear and colorless.
• One (1) 20-ounce mixing container with a 16-ounce fill line.

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.

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.

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 time 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.

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)] .

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.

The recommended Split-Dose (two-day) regimen for adultsconsists 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 hours 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.

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).

• 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.

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.

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)] .