Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Lemon Flavor 3350 420 g/4L; 11.2 g/4L; 5.72 g/4L; 1.48 g/4L Powder, For Solution, 4 l — NDC 64380-769-21 (Billing 64380-0769-21)
This is a package of 4 l of Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Lemon Flavor 3350 420 g/4L; 11.2 g/4L; 5.72 g/4L; 1.48 g/4L Powder, For Solution from Strides Pharma Science Limited, marketed since Apr 2015 and currently FDA-listed; retail pharmacies pay about $0.0046 per mL (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 059931
- GCN: 25865
- GPI-14 (Medi-Span): 46992004302120
- HICL (First Databank): 033276
- AHFS class code: 56:12.00.00
- RxCUI (RxNorm): 801054
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Osmotic Laxative class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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...
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.005 | — |
| Medicaid paysCMS SDUD · 12 mo | $0.0069 | — |
| Medicare drug plans payPart D · Q2 2026 | $0.0117 | — |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 64380-0769-21 You're viewing this Main listing | 4 L in 1 JUG | 2015-04-14 | — | Active |
Therapeutic equivalents
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 23OV73Q5G9
Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
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UNII 24RS0A988O
Lemon is a citrus fruit extract used as a natural flavoring agent and acidulant to add tart taste and help preserve medicines while improving their palatability.
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UNII 8CZS546954
A natural extract from lime fruit used as a flavoring agent and source of citric acid. It adds tart taste and may help preserve the medicine.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution, supplied as a powder, must be reconstituted with water before its use ( 2.1 , 5.8 ) On day prior to colonoscopy, instruct patients to: Eat a light breakfast or have clear liquids (avoid red and purple liquids) ( 2.2 ). Early in the evening prior to colonoscopy, fill container containing polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution's powder with lukewarm water to 4 liter fill line ( 2.2 ).
After capping container, shake vigorously several times ( 2.2 ). Instruct patients to consume water or clear liquids during and after bowel preparation up until 2 hours before time of colonoscopy ( 2.3 ). Adults: Drink at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or rectal effluent is clear.
For nasogastric tube (NGT), rate is 1.2 to 1.8 liters per hour ( 2.3 ). Pediatric patients (aged 6 months or greater ): Drink 25 mL/kg/hour orally or administer by NGT. Continue drinking until watery stool is clear and free of solid matter ( 2.3 ).
2.1Dosage Overview Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion [see Dosage and Administration (2.2), Warnings and Precautions (5.8)]. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions (5.7)]. The 4 liter reconstituted polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution contains: 420 grams of polyethylene glycol (PEG) 3350, 5.72 grams of sodium bicarbonate, 11.2 grams of sodium chloride, and 1.48 grams of potassium chloride.
Besides these, the lemon flavored solution contain flavoring ingredients acesulfame potassium 0.1 gram and flavor lemon 0.4 grams while orange flavored solution contains acesulfame potassium 0.1 gram and flavor orange 0.6 grams respectively.
2.2Administration Instructions Prior to Dosage On the day prior to the colonoscopy, instruct patients to: a) Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast. b) Early in the evening prior to colonoscopy , fill the supplied container containing the polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution's powder with lukewarm water (to facilitate dissolution) to the 4 liter fill line. The solution is clear and colorless when reconstituted to a final volume of 4 liters. c) After capping the container, shake vigorously several times to ensure that the ingredients are dissolved.
When reconstituted use within 48 hours.
2.3Dosage The following is the recommended dose of reconstituted polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution for adults and pediatric patients ≥ 6 months. Instruct patients they may consume water or 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.
Adults: Instruct patients to drink a total of up to 4 liters at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. For NGT, rate is 20 to 30 mL per minute (1.2 to 1.8 liters per hour).
Pediatric Patients ≥ 6 Months: Pediatric patients should drink 25 mL/kg/hour until the stool is watery, clear, and free of solid matter. If pediatric patients are unable to drink the reconstituted polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution, the solution may be given by nasogastric (NGT). NGT administration is at t… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For oral solution: polyethylene glycol 3350 420 grams, sodium bicarbonate 5.72 grams, sodium chloride 11.2 grams, potassium chloride 1.48 grams and flavoring ingredients acesulfame potassium 0.1 gram and flavor lemon 0.4 grams for lemon flavor, acesulfame potassium 0.1 gram and flavor orange 0.6 grams for orange flavor respectively; supplied in one 5 liter disposable jug ( 3 ). For oral solution: One 5 liter jug with powder for reconstitution with water. Each 5 liter jug contains: polyethylene glycol 3350 USP-NF 420 g, sodium bicarbonate USP 5.72 g, sodium chloride USP 11.2 g, potassium chloride USP 1.48 g and flavoring ingredients (acesulfame potassium 0.1 g and flavor lemon 0.4 g for lemon flavor or acesulfame potassium 0.1 gram and flavor orange 0.6 g for orange flavor).
When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.
⛔ Contraindications ▾
4 CONTRAINDICATIONS Gastrointestinal (GI) obstruction, ileus, or gastric retention ( 4 , 5.6 ) Bowel perforation ( 4, 5.6 ) Toxic colitis or toxic megacolon ( 4 ) Known allergy or hypersensitivity to components of polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution ( 4, 11 ) Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is contraindicated in the following conditions: Gastrointestinal (GI) obstruction, ileus, or gastric retention Bowel perforation Toxic colitis or toxic megacolon Known allergy or hypersensitivity to any component of polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution [see How Supplied/Storage and Handling ( 16 )]
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment – assess concurrent medications and consider testing in some patients ( 5.1, 5.2 , 5.3, 5.4 ) Patients with renal insufficiency – use caution, ensure adequate hydration and consider testing ( 5.4 ) Suspected GI obstruction or perforation – rule out the diagnosis before administration ( 4 , 5.6 ) Patients at risk for aspiration – observe during administration ( 5.7 ) Not for direct ingestion – dilute and take with additional water ( 5.8 )
5.1Serious Fluid and Serum Chemistry Abnormalities Advise patients to hydrate adequately before, during, and after the use of polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride 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, sodium chloride, sodium bicarbonate and potassium chloride 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. Fluid and electrolyte abnormalities should be corrected before treatment with polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. In addition, use caution when prescribing polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride 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, sodium chloride, sodium bicarbonate and potassium chloride 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). Pre-dose and post-colonoscopy ECGs should be considered 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, sodium chloride, sodium bicarbonate and potassium chloride 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.
5.4Renal Impairment Use caution when prescribing polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride 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). 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.
5… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions (≥3%) are: nausea, abdominal fullness and bloating. Abdominal cramps, vomiting and anal irritation occur less frequently ( 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 serious or otherwise important adverse reactions 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)]. Renal Impairment [see Warnings and Precautions (5.4)] Colonic Mucosal Ulcerations, Ischemic Colitis and Ulcerative 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)]. Direct Ingestion [see Warnings and Precautions (5.8)].
The following adverse reactions have been identified during post-approval use of polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients) to administration of polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution.
Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions.
Published literature contains isolated reports of serious adverse reactions following the administration of PEG-electrolyte solution products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and "butterfly-like" infiltrates on chest X-ray after vomiting and aspirating PEG.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Some drugs increase risks due to fluid and electrolyte changes ( 7.1 ) Oral medication taken within 1 hour of start of each dose may not be absorbed properly ( 7.2 )
7.1Drugs that May Lead to Fluid and Electrolyte Abnormalities Use caution when prescribing polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution for patients 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 prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , and 5.4 )] in patients taking these concomitant medications.
7.2Potential for Altered Drug Absorption Oral medication administered within one hour of the start of administration of polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution may be flushed from the gastrointestinal tract and the medication may not be absorbed properly.
7.3Stimulant Laxatives Concurrent use of stimulant laxatives and polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride 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, sodium chloride, sodium bicarbonate and potassium chloride for oral solution.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Animal reproduction studies have not been conducted with polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. It is also not known whether polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride 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, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is administered to a nursing woman.
8.4Pediatric Use Safety and effectiveness of polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution in adults with additional safety and efficacy data from published studies of similar formulations. Use of polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate.
Dehydration has been reported in one child and hypokalemia has been reported in 3 children.
8.5Geriatric Use Clinical studies of polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride 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, sodium chloride, sodium bicarbonate and potassium chloride 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, sodium chloride, sodium bicarbonate and potassium chloride for oral solution were not assessed. Available pharmacokinetic information for oral PEG 3350 suggests that it is poorly absorbed.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING In powdered form, for oral administration as a solution following reconstitution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is available in a disposable jug in powdered form containing: Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution with Flavor Packs : polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients acesulfame potassium 0.1 gram and flavor lemon 0.4 grams for lemon flavor and acesulfame potassium 0.1 gram and flavor orange 0.6 grams for orange flavor.
When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. Storage: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. When reconstituted, keep solution refrigerated.
Use within 48 hours. Discard unused portion. Keep out of reach of children.
Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is available in following flavors: Drug product NDC Package Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution 64380-768-21 Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution with lemon flavor 64380-769-21 5 L disposable jug with a 4 L fill line Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution with orange flavor 64380-770-21
📋 Description ▾
11 DESCRIPTION For oral solution: Each 5 liter (5L) polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution jug contains a white powder for reconstitution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium chloride, sodium bicarbonate and potassium chloride) for oral solution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is available in unflavored, lemon and orange flavors.
Each 5 liter jug contains: polyethylene glycol 3350 USP-NF 420 g, sodium bicarbonate USP 5.72 g, sodium chloride USP 11.2 g, potassium chloride USP 1.48 g. Besides these, the lemon flavored powder contains flavoring ingredients acesulfame potassium 0.1 gram and flavor lemon 0.4 grams while orange flavor powder contains acesulfame potassium 0.1 gram and flavor orange 0.6 grams respectively. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water.
Polyethylene Glycol 3350, NF 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 PEG3350.jpg sodbicarbonate.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling ( Medication Guide ). Instruct patients: To let you know if they have trouble swallowing or are prone to regurgitation or aspiration. Not to take other laxatives while they are taking polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution.
To consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. That if they experience severe bloating, distention or abdominal pain, the administration of the solution should be slowed or temporarily discontinued until the symptoms abate. Advise patients to report these events to their health care provider.
That if they have hives, rashes, or any allergic reaction, they should discontinue the medication and contact their health care provider. Medication should be discontinued until they speak to their physician. To contact their healthcare provider if they develop signs and symptoms of dehydration [see Warnings and Precautions ( 5.1 )] .
That oral medication administered within one hour of the start of administration of polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution may be flushed from the GI tract and the medication may not be absorbed completely. Manufactured by: Strides Pharma Science Limited Bengaluru – 562106, India. Distributed by: Strides Pharma Inc.
Bridgewater, NJ 08807 Revised: 09/2025
💬 Medication Guide ▾
MEDICATION GUIDE Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution ( pol" ee eth' i leen glye' kol 3350, soe' dee um klor' ide, soe' dee um bye kar' bo nate and poe tas' ee um klor' ide ) Read this Medication Guide before you start taking polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride 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, sodium chloride, sodium bicarbonate and potassium chloride for oral solution? Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride 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 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, sodium chloride, sodium bicarbonate and potassium chloride 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, sodium chloride, sodium bicarbonate and potassium chloride for oral solution: 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, sodium chloride, sodium bicarbonate and potassium chloride for oral solution " for more information about side effects.
What is polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution? Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a prescription medicine used by adults to clean the colon before a colonoscopy. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution cleans your colon by causing you to have diarrhea.
Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is safe and effective for use in pediatric patients aged 6 months and older. Who should not take polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution?
Do not take polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride 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) problems with food and fluid emptying from your stomach (gastric retention) a very dilated intestine (bowel) an allergy to any of the ingredients in polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution.
See the end of this leaflet for a complete list of ingredients in polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. What should I tell my healthcare provider before taking polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution? Before you take polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride 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 seizu… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long term studies in animals have not been performed to evaluate carcinogenic potential of polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. Studies to evaluate the possible impairment of fertility or mutagenic potential of polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution have not been performed.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - UNFLAVORED PACK unflavored.jpg
PRINCIPAL DISPLAY PANEL - LEMON FLAVORED PACK lemon.jpg
PRINCIPAL DISPLAY PANEL - ORANGE FLAVORED PACK orange.jpg