Generic Name
Glycol-3350
Brand Names
electrolyteswith, GaviLyte, GaviLyte-N, GoLYTELY, Peg-3350, Trilyte
FDA approval date: July 13, 1984
Classification: Potassium Salt
Form: Powder
What is electrolyteswith (Glycol-3350)?
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. Polyethylene Glycol 3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.
Approved To Treat
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Brand Information
Polyethylene Glycol 3350 and electrolytes - Unflavored (Polyethylene Glycol 3350 and electrolytes - Unflavored)
1DESCRIPTION
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
Sodium Bicarbonate, USP
The chemical name is NaHCO
Sodium Chloride, USP
The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:
NA
Potassium Chloride, USP
The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:
K-Cl
2HOW SUPPLIED/STORAGE AND HANDLING
Polyethylene Glycol 3350 and electrolytes for oral solution, USP is supplied in a 5-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white powder.
Polyethylene Glycol 3350 and electrolytes for oral solution, USP with Lemon Flavor is supplied in a 5-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride, acesulfame potassium 0.2 g and lemon flavor 0.1 g as a white powder.
Polyethylene Glycol 3350 and electrolytes for oral solution, USP with Orange Flavor is supplied in a 5-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride, acesulfame potassium 0.2 g and orange flavor 0.4 g as a white powder.
• When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride.
Polyethylene Glycol 3350 and electrolytes for oral solution, USP is available in following flavors:
Storage
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see Controlled Room Temperature].
Store reconstituted solution of Polyethylene Glycol 3350 and electrolytes for oral solution at 2° to 8°C (36° to 46°F). Do not freeze
3PATIENT 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
- 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.
- To discontinue administration of the solution and contact their healthcare provider if they develop symptoms of a hypersensitivity reaction
Manufactured by:
Strides Pharma Science Ltd.
Bengaluru-562106, India
Distributed by:
Strides Pharma Inc.
Bridgewater, NJ 08807
Revised: 09/2025
4PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel
FILL TO THE TOP OF THE LINE ON BOTTLE
NDC 64380-765-21
TO PHARMACIST AND PATIENT:
Mixing information is on base
label. Package insert may be
removed before dispensing
Dispense the enclosed Medication Guide to each patient
Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP
When reconstituted with water to a volume of 4 liters, this solution contains PEG-3350 59 g/L, sodium sulfate 5.69 g/L, sodium bicarbonate 1.69 g/L, sodium chloride 1.47 g/L, and potassium chloride 0.743 g/L.
Each disposable jug contains, in powdered form: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g
RX
only
Manufactured by Strides Pharma Science Ltd., Bengaluru-562106, India
Distributed by Strides Pharma Inc. Bridgewater
5PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 64380-766-21
TO PHARMACIST AND PATIENT:
Mixing information is on base
label. Package insert may be
removed before dispensing. Dispense the enclosed Medication Guide to each patient
Lemon Flavor
Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP with Lemon Flavor
When reconstituted with water to a volume of 4 liters, this solution contains PEG-3350 59 g/L, sodium sulfate 5.69 g/L, sodium bicarbonate 1.69 g/L, sodium chloride 1.47 g/L, and potassium chloride 0.743 g/L.
Each disposable jug contains, in powdered form: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g, flavorlemon 0.1 g
RX
only
Manufactured by Strides Pharma Science Ltd., Bengaluru-562106, India
Distributed by Strides Pharma Inc. Bridgewater
6PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 64380-767-21
TO PHARMACIST AND PATIENT:
Mixing information is on base
label. Package insert may be
removed before dispensing. Dispense the enclosed Medication Guide to each patient
Orange Flavor
Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP with Orange Flavor
When reconstituted with water to a volume of 4 liters, this solution contains PEG-3350 59 g/L, sodium sulfate 5.69 g/L, sodium bicarbonate 1.69 g/L, sodium chloride 1.47 g/L, and potassium chloride 0.743 g/L.
Each disposable jug contains, in powdered form: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g, flavor orange 0.4 g
RX
only
Manufactured by Strides Pharma Science Ltd, Bengaluru-562106, India
Distributed by Strides Pharma Inc. Bridgewater
