GAVILYTE G TM polyethylene glycol-3350 and Electrolytes 3350 236 g/274.31g; 22.74 g/274.31g; 6.74 g/274.31g; 5.86 g/274.31g; 2.97 g/274.31g Powder, For Solution, 274.31 g
🆔 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
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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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UNII 7CVR7L4A2D
A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
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UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
2 inactive ingredients listed in the exact product block matched to this NDC.
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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.Inactive ingredient FAQ
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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 | $0.005 | — |
| Medicaid paysCMS SDUD · 12 mo | $0.0057 | — |
| Medicare drug plans payPart D · Q2 2026 | $0.0100 | — |
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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 |
|---|---|---|---|
| 43386-0090-19 You're viewing this | 274.31 g in 1 BOTTLE (43386-090-19) | 2009-06-01 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE GaviLyte-G 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 ) GaviLyte-G 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 Gavilyte-G. Reconstitute Gavilyte-G with water prior to ingestion. Do not take oral medications within 1 hour before the start or during administration of Gavilyte-G.
( 2.1 ) Do not take other laxatives while taking Gavilyte-G. 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 Gavilyte-G. Adult Dosing Regimen ( 2.2 ): On day prior to colonoscopy, instruct patients to consume a light breakfast at least 2 hours before starting Gavilyte-G. Begin the recommended dosage regimen for Gavilyte-G 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 Gavilyte-G [ see Warnings and Precautions ( 5.1 )]. Reconstitute Gavilyte-G with water prior to ingestion, do not take undissolved Gavilyte-G [ 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 Gavilyte-G [ see Drug Interactions ( 7.2 )]. Do not take other laxatives while taking Gavilyte-G [ 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 Gavilyte-G.
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 Gavilyte-G 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 Gavilyte-G. Begin the recommended dosage regiment for Gavilyte-G early in the evening on the day before colonoscopy. Instruct patients to take Gavilyte-G in conjunction with clear liquids as follows: This preparation can be used with or without the lemon flavor pack.
The pharmacist will add the lemon flavor pack prior to dispensing ( see packet instructions ) 4 Liter Jug Fill the supplied container containing the Gavilyte-G 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 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. Administration via a Nasogastric Tube For patients with a nasogastric tube, administer the reconstituted Gavilyte-G solution at a rate of 20 to 30 mL per minute (1.2 to 1.8 liters per hour).
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For Oral Solution: 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 and 2 g favoring agent supplied in one 4 liter disposable jug. ( 3 ) 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 to off-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.
⛔ 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 Gavilyte-G ( 4 , 5.8 ) GaviLyte-G 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 Gavilyte-G [ 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 GaviLyte-G. 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 GaviLyte-G, 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 GaviLyte-G. In addition, use caution when prescribing GaviLyte-G 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 GaviLyte-G 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 GaviLyte-G 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 GaviLyte-G 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 Intersections ( 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 Co…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions are: nausea, abdominal fullness and bloating, abdominal cramps, vomiting and anal irritation ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-866-403-7592 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 Gavilyte-G 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 GaviLyte-G 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 Gavilyte-G can reduce the absorption of other administered drugs. Administer oral medications within one hour before the start of administration of Gavilyte-G [see Dosage and Administration ( 2.1 )].
7.3Stimulant Laxatives Concurrent use of stimulant laxatives and GaviLyte-G may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking Gavilyte-G [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 GaviLyte-G. It is also not known whether GaviLyte-G can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GaviLyte-G 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 GaviLyte-G is administered to a nursing woman.
8.4Pediatric Use Safety and effectiveness of GaviLyte-G in pediatric patients have not been established.
8.5Geriatric Use Clinical studies of GaviLyte-G 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 Gavilyte-G 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 Gavilyte-G 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 GaviLyte-G. It is also not known whether GaviLyte-G can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GaviLyte-G should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of GaviLyte-G in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of GaviLyte-G 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 GaviLyte-G induces as diarrhea which rapidly cleanses the bowel, usually within four hours.
12.3Pharmacokinetics The pharmacokinetics of PEG 3350 following administration of GaviLyte-G were not assessed. Available pharmacokinetic information for oral PEG 3350 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 Gavilyte-G (polyethylene glycol 3350 and electrolytes for oral solution) is supplied in a 4-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 to off 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.
Gavilyte-G 4 Liter Disposable Jug NDC 43386-090-19 Storage Store in sealed container at 15° to 30°C (59° to 86°F). Store reconstituted solution of Gavilyte-G at 2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration ( 2.1 )].
📋 Description ▾
11 DESCRIPTION Gavilyte-G 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 4 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 to off-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 a b c
💬 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 Gavilyte-G with water prior to ingestion. Not to take other laxatives while they are taking Gavilyte-G.
Not to take oral medications within 1 hour before the start or during the administration of Gavilyte-G. 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 )]. LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc. Manufactured by: Novel Laboratories, Inc.
Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Naples FL, 34108 SAP code: 278923 Rev: 11/2024 Image
💬 Medication Guide ▾
MEDICATION GUIDE GaviLyte™-G (GAV-ee-LITE-G) (PEG-3350 (236 g) and Electrolytes for Oral Solution, USP) Read this Medication Guide before you start taking GaviLyte-G. 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 GaviLyte-G?
GaviLyte-G 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 GaviLyte-G 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 GaviLyte-G: 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 GaviLyte-G?" for more information about side effects.
What is GaviLyte-G? GaviLyte-G is a prescription medicine used by adults to clean the colon before a colonoscopy or barium enema X-ray examination. GaviLyte-G 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 GaviLyte-G is safe and effective in children. Who should not take GaviLyte-G?
Do not take GaviLyte-G if your heathcare 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 (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 GaviLyte-G. See the end of this Medication Guide for a complete list of ingredients in GaviLyte-G.
What should I tell my healthcare provider before taking GaviLyte-G? Before you take GaviLyte-G, 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 GaviLyte-G 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 GaviLyte-G passes into your breast milk. You and your healthcare provider should decide if you will take GaviLyte-G while breastfeeding.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. GaviLyte-G may affect how other medicines work. Do not take medicines by mouth within 1 hour of starting Gavilyte-G or after you start taking Gavilyte-G.
Especially tell your healthcare provider if you take: medicines for blood pressure or heart problems medicines for kidney problems medicines for seizures water pills (diuretics) non-steroidal anti-inflammatory medicines (NSAID) pain medicines laxatives starch-based thickeners. For patients who have trouble swallowing, do not mix Gavilyte-G with starch-based thickeners. 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…