GoLYTELY Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride 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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Supplement & herbal interactions
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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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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 | $0.006 | — |
| 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 · Q2 2026 | $0.0060 | — |
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🔁 Therapeutic equivalents
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 24338-0236-01 You're viewing this | 4 L in 1 BOTTLE, PLASTIC (24338-236-01) | 2026-04-17 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults. GoLYTELY 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 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Preparation and Administration ( 2.1 ): Correct fluid and electrolyte abnormalities before treatment with GoLYTELY. Reconstitute GoLYTELY with water prior to ingestion. Do not take oral medications within 1 hour before the start or during administration of GoLYTELY.
( 2.1 ) Do not take other laxatives while taking GoLYTELY. 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 GoLYTELY. Adult Dosing Regimen ( 2.2 ): On day prior to colonoscopy, instruct patients to consume a light breakfast at least 2 hours before starting GoLYTELY. Begin the recommended dosage regimen for GoLYTELY 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 GoLYTELY [see Warnings and Precautions ( 5.1 )] . Reconstitute GoLYTELY with water prior to ingestion, do not take undissolved GoLYTELY [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 GoLYTELY [see Drug Interactions ( 7.2 )] . Do not take other laxatives while taking GoLYTELY [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 GoLYTELY.
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 GoLYTELY 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 GoLYTELY. Begin the recommended dosage regiment for GoLYTELY early in the evening on the day before colonoscopy. Instruct patients to take GoLYTELY in conjunction with clear liquids as follows: 4 Liter Jug Fill the supplied container containing the GoLYTELY 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 GoLYTELY 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 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. 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 per 4 liters.
⛔ Contraindications ▾
4 CONTRAINDICATIONS GoLYTELY 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 GoLYTELY [see Warnings and Precautions ( 5.8 )] 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 GoLYTELY ( 4 , 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 GoLYTELY. 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 GoLYTELY, 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 GoLYTELY. In addition, use caution when prescribing GoLYTELY 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 GoLYTELY 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 GoLYTELY 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 GoLYTELY 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 in Specific Populations ( 8.6 )] .
5.5 Colonic Mucosal Ulcerations and Ischemic Colit…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 GoLYTELY 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)]. Most common adverse reactions are: nausea, abdominal fullness, bloating, abdominal cramps, vomiting and anal irritation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 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 GoLYTELY 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 GoLYTELY can reduce the absorption of other administered drugs. Administer oral medications within one hour before the start of administration of GoLYTELY [see Dosage and Administration ( 2.1 )] .
7.3Stimulant Laxatives Concurrent use of stimulant laxatives and GoLYTELY may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking GoLYTELY [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 GoLYTELY. It is also not known whether GoLYTELY can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GoLYTELY 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 GoLYTELY is administered to a nursing woman.
8.4Pediatric Use Safety and effectiveness of GoLYTELY in pediatric patients have not been established.
8.5Geriatric Use Clinical studies of GoLYTELY 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 GoLYTELY 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 GoLYTELY 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 GoLYTELY. It is also not known whether GoLYTELY can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GoLYTELY should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of GoLYTELY in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of GoLYTELY 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 GoLYTELY induces as diarrhea which rapidly cleanses the bowel, usually within four hours.
12.3Pharmacokinetics The pharmacokinetics of PEG 3350 following administration of GoLYTELY 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 GoLYTELY (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 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.
GoLYTELY 4 Liter Disposable Jug NDC 24338-236-01 Storage Store in sealed container at 15° to 30°C (59° to 86°F). Store reconstituted solution of GoLYTELY at 2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration ( 2.1 )] .
📦 Storage and Handling ▾
Storage Store in sealed container at 15° to 30°C (59° to 86°F). Store reconstituted solution of GoLYTELY at 2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration ( 2.1 )] .
📋 Description ▾
11 DESCRIPTION GoLYTELY 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 powder. Polyethylene Glycol 3350, USP 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 polyethylene glycol 3350 sodium sulfate sodium bicarbonate
💬 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 GoLYTELY with water prior to ingestion. Not to take other laxatives while they are taking GoLYTELY.
Not to take oral medications within 1 hour before the start or during the administration of GoLYTELY. 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 for Azurity Pharmaceuticals, Inc. Woburn, MA 01801
💬 Medication Guide ▾
Medication Guide GoLYTELY® (Go-lite-ly) (PEG-3350 and Electrolytes) for oral solution Read this Medication Guide before you start taking GoLYTELY. 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 GoLYTELY?
GoLYTELY 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 GoLYTELY 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 GoLYTELY: 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 GoLYTELY” for more information about side effects.
What is GoLYTELY? GoLYTELY is a prescription medicine used by adults to clean the colon before a colonoscopy or barium enema X-ray examination. GoLYTELY 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 GoLYTELY is safe and effective in children. Who should not take GoLYTELY?
Do not take GoLYTELY 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 GoLYTELY. See the end of this Medication Guide for a complete list of ingredients in GoLYTELY. What should I tell my healthcare provider before taking GoLYTELY?
Before you take GoLYTELY, 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 GoLYTELY 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 GoLYTELY passes into your breast milk. You and your healthcare provider should decide if you will take GoLYTELY while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
GoLYTELY may affect how other medicines work. Do not take medicines by mouth within 1 hour of starting GoLYTELY or after you start taking GoLYTELY. 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 GoLYTELY 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 a new medicine. How should I take GoLYTELY? You must read, understand, and follow these instructions to take GoL…