Polyethylene Glycol 3350 and electrolytes - Unflavored 3350 236 g/4L; 22.74 g/4L; 6.74 g/4L; 5.86 g/4L; 2.97 g/4L Powder, For Solution, 4 l
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Osmotic Laxative class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Polyethylene glycol-electrolyte solution (PEG-ES) is used to empty the colon (large intestine, bowel) before a colonoscopy (examination of the inside of the colon to check for colon cancer and other abnormalities) or barium enema (a test in which the colon is filled with a fluid and then x-rays are taken) so that the doctor will have a clear view of the walls of the colon. PEG-ES is in a class of medications called osmotic laxatives. It works by causing watery diarrhea so that the stool can be emptied from the colon. The medication also contains electrolytes to prevent dehydration and other se...
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 64380-0765-21 You're viewing this | 4 L in 1 JUG (64380-765-21) | 2019-01-10 | Active |
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. (1) Polyethylene Glycol 3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Preparation and Administration (2.1): Correct fluid and electrolyte abnormalities before treatment with Polyethylene Glycol 3350 and electrolytes for oral solution. Reconstitute Polyethylene Glycol 3350 and electrolytes for oral solution with water prior to ingestion. Do not take oral medications within 1 hour before the start or during administration of Polyethylene Glycol 3350 and electrolytes for oral solution.
(2.1) Do not take other laxatives while taking Polyethylene Glycol 3350 and electrolytes for oral solution. Consume only clear liquids; avoid red and purple liquids. Consume water or other clear liquids up until 2 hours before the time of the colonoscopy.
Do not consume solid food within 2 hours before starting Polyethylene Glycol 3350 and electrolytes for oral solution. Adult Dosing Regimen (2.2): On day prior to colonoscopy, instruct patients to consume a light breakfast at least 2 hours before starting Polyethylene Glycol 3350 and electrolytes for oral solution. Begin the recommended dosage regimen for Polyethylene Glycol 3350 and electrolytes for oral solution early in the evening on the day before colonoscopy.
Drink reconstituted solution at a rate of 8 ounces every 10 minutes, until 4 liters are consumed, or rectal effluent is clear. For complete information on dosing, preparation and administration, see the full prescribing information. (2.1, 2.2)
2.1Important 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.
2.2Dosage 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 Fill the supplied container containing the Polyethylene Glycol 3350 and electrolytes for oral solution powder with lukewarm drinking water to the 4-liter fill line Do 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 shoul…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For Oral Solution: polyethylene glycol 3350 236 grams, sodium sulfate (anhydrous) 22.74 grams, sodium bicarbonate 6.74 grams, sodium chloride 5.86 grams, potassium chloride 2.97 grams, and flavoring ingredients acesulfame potassium 0.2 grams and flavor lemon 0.1 gram for lemon flavor, acesulfame potassium 0.2 grams and flavor orange 0.4 grams for orange flavor respectively; supplied in one 5 liter disposable jug 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).
⛔ Contraindications ▾
4 CONTRAINDICATIONS Gastrointestinal (GI) obstruction (4, 5.6) Bowel perforation (4, 5.6) Toxic colitis or toxic megacolon (4) Gastric retention (4) Ileus (4) Hypersensitivity to components of Polyethylene Glycol 3350 and electrolytes for oral solution (4, 5.8) 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)]
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after use. (5.1, 5.2, 7.1) Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. (5.2) Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizure, 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 testing. (5.4, 7.1, 8.6) Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. (5.5, 7.3) Patients at risk for aspiration: Observe during administration.
(5.7) Hypersensitivity reactions including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. (5.8)
5.1Serious 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) ].
5.2Cardiac 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.
5.3Seizures 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)].
5.4Renal 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-inflamm…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions are: nausea, abdominal fullness, bloating abdominal cramps, vomiting and anal irritation. (6) To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. at 1-877-244-9825 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The following clinically significant adverse reactions are described elsewhere in the labeling: 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)] 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. Cardiovascular: arrhythmia, atrial fibrillation, peripheral edema, asystole, and acute pulmonary edema after aspiration [see Warnings and Precautions (5.2)]. Nervous system: tremor, seizure [see Warnings and Precautions (5.3)] Hypersensitivity: Urticaria/rash, pruritus, dermatitis, rhinorrhea, dyspnea, chest and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock [see Contraindications (4), Warnings and Precautions (5.8)] Gastrointestinal: Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients).
Other less common adverse reactions include: abdominal cramps, vomiting, "butterfly-like" infiltrates on chest X-ray after vomiting and aspirating PEG, anal irritation, and upper GI bleeding from Mallory-Weiss Tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD).
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Some drugs increase risks due to fluid and electrolyte changes (7.1)
7.1Drugs 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.
7.2Potential 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)] .
7.3Stimulant 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)].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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.
8.3Nursing 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.
8.4Pediatric Use Safety and effectiveness of Polyethylene Glycol 3350 and electrolytes for oral solution in pediatric patients have not been established.
8.5Geriatric 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.
8.6Renal 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)].
🤰 Pregnancy ▾
8.1Pregnancy 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.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of Polyethylene Glycol 3350 and electrolytes for oral solution in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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
12.2Pharmacodynamics Polyethylene Glycol 3350 and electrolytes for oral solution induces as diarrhea which rapidly cleanses the bowel, usually within four hours.
12.3Pharmacokinetics 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.
🧬 Mechanism of Action ▾
12.1Mechanism 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
📦 How Supplied / Storage and Handling ▾
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: 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 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)].
📋 Description ▾
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 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, 2.97 g potassium chloride, acesulfame potassium 0.2 grams and lemon flavor 0.1 gram as a white powder.
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, 2.97 g potassium chloride, acesulfame potassium 0.2 grams and orange flavor 0.4 grams as a white powder. Polyethylene Glycol 3350, NF Sodium Sulfate, USP The chemical name is Na 2 SO 4 .
The average Molecular Weight is 142.04. The structural formula is: Sodium Bicarbonate, USP The chemical name is NaHCO 3 . 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 1 2 3
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-Approved Patient Labeling (Medication Guide and Instructions for Use). Instruct patients: 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)]. Manufactured by: Strides Pharma Science Ltd. Bengaluru-562106, India Distributed by: Strides Pharma Inc.
Bridgewater, NJ 08807 Revised: 09/2025
💬 Medication Guide ▾
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: abnormal heartbeats (arrhythmias) that can cause death. seizures . This can happen even if you have never had a seizure. kidney problems.
Your chance of having fluid loss and changes in body salts with Polyethylene Glycol 3350 and electrolytes for oral solution is higher if you: have heart problems. have kidney problems. take water pills or non-steroidal anti-inflammatory drugs (NSAIDS). 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: vomiting that prevents you from keeping down the solution. dizziness. urinating less often than normal. headache.
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: a blockage in your bowel (obstruction). an opening in the wall of your stomach or intestine (bowel perforation). a very dilated intestine (toxic megacolon). problems with food and fluid emptying from your stomach (gastric retention). a problem with food moving too slowly through your intestines (ileus). an allergy to any of the ingredients in Polyethylene Glycol 3350 and electrolytes for oral solution.
See the end of this Medication Guide for a complete list of ingredients in Polyethylene Glycol 3350 and electrolytes for oral solution. 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: have heart problems. have stomach or bowel problems. have ulcerative colitis. have problems with swallowing or gastric reflux. have a history of seizures. are withdrawing from drinking alcohol. have a low blood salt (sodium) level. have kidney problems. have any other medical conditions. are pregnant.
It is not known if Polyethylene Glycol 3350 and electrolytes for oral solution will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed. It is not known if Polyethylene Glycol 3350 and electrolytes for oral solution passes into your breast milk.
You and your healthcare provider should decide if you will take Polyethylene Glycol 3350 and electrolytes for oral solution while breastfeeding. Tell your healthcare provider about all t…