These highlights do not include all the information needed to use POLYETHYLENE GLYCOL 3350 and ELECTROLYTES FOR ORAL SOLUTION safely and effectively. See full prescribing information for POLYETHYLENE GLYCOL 3350 and ELECTROLYTES FOR ORAL SOLUTION.POLYETHYLENE GLYCOL 3350 and ELECTROLYTES for oral solution. Initial U.S. Approval: 1984

1 INDICATIONS AND USAGE

SPL UNCLASSIFIED SECTION

Polyethylene Glycol 3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults

2 DOSAGE AND ADMINISTRATION

2.1 Important Preparation and Administration Instructions

Correct fluid and electrolyte abnormalities before treatment with Polyethylene Glycol 3350 and electrolytes for oral solution [see Warnings and Precautions (5.1)].
Reconstitute Polyethylene Glycol 3350 and electrolytes for oral solution with water prior to ingestion, do not take undissolved Polyethylene Glycol 3350 and electrolytes for oral solution [see Dosage and Administration (2.2)]. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions (5.7)].
Do not take oral medications within 1 hour before the start of or during administration of Polyethylene Glycol 3350 and electrolytes for oral solution [see Drug Interactions (7.2)].
Do not take other laxatives while taking Polyethylene Glycol 3350 and electrolytes for oral solution [see Drug Interactions (7.3)].
Consume only clear liquids, avoid red and purple liquids.
Patients may consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy.
The solution is more palatable if chilled prior to administration.
Do not consume solid food within 2 hours before starting Polyethylene Glycol 3350 and electrolytes for oral solution. For the best results, do not consume solid food for 3 to 4 hours before drinking the solution.
If severe bloating, distention or abdominal pain occurs, slow or temporarily discontinue Polyethylene Glycol 3350 and electrolytes for oral solution until the symptoms abate.

2.2 Dosage Regimen

Instruct adult patients that on the day before the colonoscopy procedure, they may consume a light breakfast at least 2 hours before starting Polyethylene Glycol 3350 and electrolytes for oral solution. Begin the recommended dosage regiment for Polyethylene Glycol 3350 and electrolytes for oral solution early in the evening on the day before colonoscopy.

Instruct patients to take Polyethylene Glycol 3350 and electrolytes for oral solution in conjunction with clear liquids as follows:

4 Liter Jug

Administration via a Nasogastric Tube

For patients with a nasogastric tube, administer the reconstituted Polyethylene Glycol 3350 and electrolytes for oral solution at a rate of 20 to 30 mL per minute (1.2 to 1.8 liters per hour).

Fill the supplied container containing the Polyethylene Glycol 3350 and electrolytes for oral solution powder with lukewarm drinking water to the 4-liter fill lineDo not add any other ingredients, flavors, etc.
After capping the container, shake vigorously several times to ensure that the ingredients are dissolved.
Drink at a rate of 8 ounces every 10 minutes until the entire contents are consumed or the rectal effluent is clear. A loose watery bowel movement should result in approximately one hour.
After reconstitution, keep solution refrigerated 2° to 8°C (36° to 46°F). Do not freeze. Use within 48 hours, discard unused portion.

3 DOSAGE FORMS AND STRENGTHS

SPL UNCLASSIFIED SECTION

For Oral Solution: 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white powder. When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG-3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride (acesulfame potassium 0.2 g and flavor lemon 0.1 g for lemon flavor , acesulfame potassium 0.2 g and flavor orange 0.4 g for orange flavor).

4 CONTRAINDICATIONS

SPL UNCLASSIFIED SECTION

Polyethylene Glycol 3350 and electrolytes for oral solution, is contraindicated in the following conditions:

Gastrointestinal (GI) obstruction [see Warnings and Precautions (5.6)]
Bowel perforation [see Warnings and Precautions (5.6)]
Toxic colitis or toxic megacolon
Gastric retention
Ileus
Hypersensitivity to any component of Polyethylene Glycol 3350 and electrolytes for oral solution [see Warnings and Precautions (5.8)]

5 WARNINGS AND PRECAUTIONS

5.1 Serious Fluid and Serum Chemistry Abnormalities

Advise patients to hydrate adequately before, during, and after the use of Polyethylene Glycol 3350 and electrolytes for oral solution, . Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking Polyethylene Glycol 3350 and electrolytes for oral solution, , consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly. 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 Polyethylene Glycol 3350 and electrolytes for oral solution, .

In addition, use caution when prescribing Polyethylene Glycol 3350 and electrolytes for oral solution, for patients who have 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)].

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 Polyethylene Glycol 3350 and electrolytes for 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.

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 Polyethylene Glycol 3350 and electrolytes for 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)].

5.4 Renal Impairment

Use caution when prescribing Polyethylene Glycol 3350 and electrolytes for 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) [see Drug Interactions (7.1)]. 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 [see Use is Specific Populations (8.6)].

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 Polyethylene Glycol 3350 and electrolytes for oral solution, may increase this risk [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).

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 Polyethylene Glycol 3350 and electrolytes for oral solution [see Contraindications (4)]. Use with caution in patients with severe active ulcerative colitis.

5.7 Aspiration

Use with caution in patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration. Observe these patients during administration of Polyethylene Glycol 3350 and electrolytes for oral solution, especially if it is administered via nasogastric tube.

Do not combine Polyethylene Glycol 3350 and electrolytes for oral solutions with starch-based thickeners [see Dosage and Administration (2.1)]. Polyethylene glycol (PEG), a component of Polyethylene Glycol 3350 and electrolytes for oral solutions, when mixed with starch-thickened liquids reduces the viscosity of the starch-thickened liquid. When a PEG-based product used for another indication was mixed in starch-based pre-thickened liquids used in patients with dysphagia, thinning of the liquid occurred and cases of chocking and potential aspiration were reported.

5.8 Hypersensitivity Reactions

Polyethylene Glycol 3350 and electrolytes for oral solution contains PEG and may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus [see Adverse Reactions (6)]. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.

6 ADVERSE REACTIONS

SPL UNCLASSIFIED SECTION

The following clinically significant adverse reactions are described elsewhere in the labeling:

The following adverse reactions associated with the use of Polyethylene Glycol 3350 and electrolytes for oral solution were identified in clinical trials or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or establish a causal relationship to drug exposure.

Renal impairment [see Warnings and Precautions (5.4)]
Colonic mucosal ulcerations 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)]

7 DRUG INTERACTIONS

7.1 Drugs that May Increase Risks Due to Fluid and Electrolyte Abnormalities

Use caution when prescribing Polyethylene Glycol 3350 and electrolytes for oral solution for patients with conditions and/or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, 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)]. Consider additional patient evaluations as appropriate.

7.2 Potential for Reduced Drug Absorption

Polyethylene Glycol 3350 and electrolytes for oral solution can reduce the absorption of other administered drugs. Administer oral medications within one hour before the start of administration of Polyethylene Glycol 3350 and electrolytes for oral solution [see Dosage and Administration (2.1)].

7.3 Stimulant Laxatives

Concurrent use of stimulant laxatives and Polyethylene Glycol 3350 and electrolytes for oral solution, may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking Polyethylene Glycol 3350 and electrolytes for oral solution [see Warnings and Precautions (5.5)].

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Animal reproduction studies have not been conducted with Polyethylene Glycol 3350 and electrolytes for oral solution. It is also not known whether Polyethylene Glycol 3350 and electrolytes for oral solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Polyethylene Glycol 3350 and electrolytes for 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 Polyethylene Glycol 3350 and electrolytes for oral solution is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness of Polyethylene Glycol 3350 and electrolytes for oral solution in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of Polyethylene Glycol 3350 and electrolytes for oral solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

8.6 Renal Impairment

Use Polyethylene Glycol 3350 and electrolytes for oral solution with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function [see Drug Interactions (7.1)]. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after use of Polyethylene Glycol 3350 and electrolytes for oral solution and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions (5.4)].

11 DESCRIPTION

Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 5 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder.

Polyethylene Glycol 3350, NF

Sodium Sulfate, USP

The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:

Sodium Bicarbonate, USP

The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is:

Sodium Chloride, USP

The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:

NA+Cl-

Potassium Chloride, USP

The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:

K-Cl

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The primary mode of action is thought to be through the osmotic effect of polyethylene glycol 3350 which causes water to be retained in the colon and produces a watery stool

12.2 Pharmacodynamics

Polyethylene Glycol 3350 and electrolytes for oral solution induces as diarrhea which rapidly cleanses the bowel, usually within four hours.

12.3 Pharmacokinetics

The pharmacokinetics of PEG 3350 following administration of Polyethylene Glycol 3350 and electrolytes for oral solution were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.

16 HOW SUPPLIED/STORAGE AND HANDLING

Polyethylene Glycol 3350 and electrolytes for oral solution, USP is supplied in a 5-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white powder.

Polyethylene Glycol 3350 and electrolytes for oral solution, USP with Lemon Flavor is supplied in a 5-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride, acesulfame potassium 0.2 g and lemon flavor 0.1 g as a white powder.

Polyethylene Glycol 3350 and electrolytes for oral solution, USP with Orange Flavor is supplied in a 5-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride, acesulfame potassium 0.2 g and orange flavor 0.4 g as a white powder.

• When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride.

Polyethylene Glycol 3350 and electrolytes for oral solution, USP is available in following flavors:

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see Controlled Room Temperature].

Store reconstituted solution of Polyethylene Glycol 3350 and electrolytes for oral solution at 2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration (2.1)].

Drug product	NDC	Package
Polyethylene Glycol 3350 and electrolytes for oral solution, USP	64380-765-21	5 L disposable jug with a 4 L fill line
Polyethylene Glycol 3350 and electrolytes for oral solution, USP with Lemon Flavor	64380-766-21
Polyethylene Glycol 3350 and electrolytes for oral solution, USP with Orange Flavor	64380-767-21

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-Approved Patient Labeling (Medication Guide and Instructions for Use).

Instruct patients:

Manufactured by:

Strides Pharma Science Ltd.

Bengaluru-562106, India

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Revised: 05/2024

Medication Guide available at:

www.strides.com/peg-elect-os/

To reconstitute Polyethylene Glycol 3350 and electrolytes for oral solution with water prior to ingestion.
Not to take other laxatives while they are taking Polyethylene Glycol 3350 and electrolytes for oral solution.
Not to take oral medications within 1 hour before the start or during the administration of Polyethylene Glycol 3350 and electrolytes for oral solution.
To take only clear liquids but avoid red and purple liquids.
To consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy.
To follow the directions in the Instructions for Use on how to prepare and administer the product.
If they experience severe bloating, distention or abdominal pain, to slow or temporarily discontinue drinking the solution and to contact their healthcare provider.
To contact their healthcare provider if they develop signs and symptoms of dehydration or if they experience altered consciousness or seizures. [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4)] .
To discontinue administration of the solution and contact their healthcare provider if they develop symptoms of a hypersensitivity reaction [see Warnings and Precautions (5.8)].

SPL MEDGUIDE SECTION

Medication Guide

POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES FOR ORAL SOLUTION, USP

(pol″ ee eth′ i leen glye′ kol 3350)

Read this Medication Guide before you start taking Polyethylene Glycol 3350 and electrolytes for oral solution. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Polyethylene Glycol 3350 and electrolytes for oral solution?

Polyethylene Glycol 3350 and electrolytes for oral solution and other osmotic bowel preparations can cause serious side effects, including:

Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood.

These changes can cause:

Your chance of having fluid loss and changes in body salts with Polyethylene Glycol 3350 and electrolytes for oral solution is higher if you:

Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking Polyethylene Glycol 3350 and electrolytes for oral solutions:

See Section "What are the possible side effects of Polyethylene Glycol 3350 and electrolytes for oral solution" for more information about side effects.

What is Polyethylene Glycol 3350 and electrolytes for oral solution?

Polyethylene Glycol 3350 and electrolytes for oral solution is a prescription medicine used by adults to clean the colon before a colonoscopy or barium enema X-ray examination. Polyethylene Glycol 3350 and electrolytes for oral solution cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy.

It is not known if Polyethylene Glycol 3350 and electrolytes for oral solution is safe and effective in children.

Who should not take Polyethylene Glycol 3350 and electrolytes for oral solution?

Do not take Polyethylene Glycol 3350 and electrolytes for oral solution if your healthcare provider has told you that you have:

What should I tell my healthcare provider before taking Polyethylene Glycol 3350 and electrolytes for oral solution?

Before you take Polyethylene Glycol 3350 and electrolytes for oral solution, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Polyethylene Glycol 3350 and electrolytes for oral solution may affect how other medicines work. Do not take medicines by mouth within 1 hour of starting Polyethylene Glycol 3350 and electrolytes for oral solution or after you start taking Polyethylene Glycol 3350 and electrolytes for oral solution. Especially tell your healthcare provider if you take:

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine

How should I take Polyethylene Glycol 3350 and electrolytes for oral solution?

You must read, understand, and follow these instructions to take Polyethylene Glycol 3350 and electrolytes for oral solution the right way.

What are the possible side effects of Polyethylene Glycol 3350 and electrolytes for oral solution?

Polyethylene Glycol 3350 and electrolytes for oral solution can cause serious side effects, including:

The most common side effects of Polyethylene Glycol 3350 and electrolytes for oral solution, USP include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Polyethylene Glycol 3350 and electrolytes for oral solution. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Polyethylene Glycol 3350 and electrolytes for oral solution, USP?

Keep Polyethylene Glycol 3350 and electrolytes for oral solution, USP and all medicines out of the reach of children.

General information about the safe and effective use of Polyethylene Glycol 3350 and electrolytes for oral solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Polyethylene Glycol 3350 and electrolytes for oral solution, USP for a condition for which it was not prescribed. Do not give Polyethylene Glycol 3350 and electrolytes for oral solution, USP to other people, even if they are going to have the same procedure you are. It may harm them.

This Medication Guide summarizes important information about Polyethylene Glycol 3350 and electrolytes for oral solution. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.

For more information, go to www.strides.com or call toll free number 1-877-244-9825.

What are the ingredients in Polyethylene Glycol 3350 and electrolytes for oral solution, USP?

Polyethylene Glycol 3350 and electrolytes for oral solution, USP comes in a 5-liter jug with polyethylene glycol 3350, sodium sulfate, sodium bicarbonate, sodium chloride, and potassium chloride powder.

Active ingredients: polyethylene glycol 3350, sodium sulfate, sodium bicarbonate, sodium chloride, and potassium chloride.

Inactive ingredients: Lemon and Orange Flavored Polyethylene Glycol 3350 and electrolytes for oral solution, USP only (acesulfame potassium, natural orange flavor powder, natural flavor lemon powder)

Manufactured by:

Strides Pharma Science Ltd.

Bengaluru-562106, India

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Revised: 05/2024

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Medication Guide available at:

www.strides.com/peg-elect-os/

FILL TO THE TOP OF THE LINE ON BOTTLE

Rx Only

Dispense the enclosed Medication Guide to each patient.

Polyethylene Glycol 3350 and Electrolytes

for Oral Solution, USP

Read this Instructions for Use and the Medication Guide before you start taking Polyethylene Glycol 3350 and electrolytes for oral solution.

Important information

• Do not take undissolved Polyethylene Glycol 3350 and electrolytes for oral solution powder that has not been mixed with water (diluted). It may increase your risk of nausea, vomiting and fluid loss (dehydration).

• Do not eat solid foods at least 2 hours before taking Polyethylene Glycol 3350 and electrolytes for oral solution. For best results, do not consume solid food for 3 to 4 hours before drinking Polyethylene Glycol 3350 and electrolytes for oral solution.

Prepare and take Polyethylene Glycol 3350 and electrolytes for oral solution

1 Add lukewarm drinking water to the fill mark (4 liters) on the jug. Do not add any other ingredients or flavors. Do not mix Polyethylene Glycol 3350 and electrolytes with starch-based thickeners.

2 Place the cap securely on the jug. Shake the jug very well (vigorously) several times to make sure that the ingredients are mixed well (dissolved).

3 Drink one 8-ounce (240 mL) cup of the mixed solution rapidly every 10 minutes. A loose watery bowel (stool) movement should result in approximately 1 hour. Continue drinking until you finish the entire contents (4-liters), your stools are clear, or as directed by your healthcare provider. If giving Polyethylene Glycol 3350 and electrolytes for oral solution through the nasogastric (NG) tube, place Polyethylene Glycol 3350 and electrolytes for oral solution into the NG tube at a rate of 20 to 30 ml per minute (1.2 or 1.8 liters per hour).

4 Throw away (discard) unused Polyethylene Glycol 3350 and electrolytes for oral solution within 48 hours (2 days).

Keep Polyethylene Glycol 3350 and electrolytes for oral solution and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration

Manufactured by:

Strides Pharma Science Ltd.

Bengaluru-562106, India

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Revised : 05/2024

abnormal heartbeats (arrhythmias) that can cause death.
seizures . This can happen even if you have never had a seizure.
kidney problems.

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