GaviLyte - C TM polyethylene glycol-3350 and electrolytes with Flavor Pack 3350 240 g/278.26g; 5.84 g/278.26g; 2.98 g/278.26g; 6.72 g/278.26g; 22.72 g/278.26g Powder, For Solution, 278.26 g — NDC 43386-060-19 (Billing 43386-0060-19)
This is a package of 278.26 g of GaviLyte - C TM polyethylene glycol-3350 and electrolytes with Flavor Pack 3350 240 g/278.26g; 5.84 g/278.26g; 2.98 g/278.26g; 6.72 g/278.26g; 22.72 g/278.26g Powder, For Solution from Lupin Pharmaceuticals,Inc., marketed since Jan 2009 and currently FDA-listed; retail pharmacies pay about $0.0039 per mL (NADAC). It is this product's only package size.
Past resolved recalls for this product (2)
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): 062659
- GCN: 98433
- GPI-14 (Medi-Span): 46992005302140
- HICL (First Databank): 034667
- AHFS class code: 56:12.00.00
- RxCUI (RxNorm): 966914
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 | $0.004 | — |
| Medicaid paysCMS SDUD · 12 mo | $0.0056 | — |
| Medicare drug plans payPart D · Q2 2026 | $0.0056 | — |
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 |
|---|---|---|---|---|
| 43386-0060-19 You're viewing this Main listing | 278.26 g in 1 BOTTLE Sample | 2009-06-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| GaviLyte - C TM 3350 240 g/278.26g; 5.84 g/278.26g; 2.98 g/278.26g; 6.72 g/278.26g; 22.72 g/278.26gthis 43386-0060-19 | Lupin | 278.26 g | $0.004 | — | Availability likely | — |
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.
-
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.
-
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.
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 ▾
INDICATIONS AND USAGE GaviLyte- C with flavor pack is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION GaviLyte- C with flavor pack can be administered orally or by nasogastric tube. Patients should fast at least 3 hours prior to administration. A one hour waiting period after the appearance of clear liquid stool should be allowed prior to examination to complete bowel evacuation.
No foods except clear liquids should be permitted prior to examination after GaviLyte- C with flavor pack administration. ORAL: The recommended adult oral dose is 240 mL (8 fl. oz.) every 10 minutes (see INFORMATION FOR PATIENTS). Lavage is complete when fecal discharge is clear.
Lavage is usually complete after the ingestion of 3 to 4 liters. NASOGASTRIC TUBE: GaviLyte- C with flavor pack is administered at a rate of 20 to 30 mL per minute (1.2 to
1.8L/hour). PREPARATION OF GaviLyte- C with flavor pack SOLUTION: This preparation can be used with or without the lemon flavor pack. 1.
To add flavor, tear open lemon flavor pack at the indicated marking and pour contents into the bottle BEFORE reconstitution. 2. SHAKE WELL to incorporate flavoring into the powder.
3. Add tap water to FILL line. Replace cap tightly and mix or shake well until all ingredients have dissolved.
(No other additional ingredients, e.g. flavorings, should be added to the solution.) Note: If not using flavor pack, omit steps one and two, above.
⛔ Contraindications ▾
CONTRAINDICATIONS GaviLyte- C with flavor pack is contraindicated in patients known to be hypersensitive to any of the components. GaviLyte- C with flavor pack is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.
⚠️ Warnings ▾
WARNINGS Flavor pack is for use only in combination with the contents of the accompanying 4 liter container. No other additional ingredients (e.g., flavorings) should be added to the solution. GaviLyte- C with flavor pack should be used with caution in patients with severe ulcerative colitis.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Nausea, abdominal fullness and bloating are the most frequent adverse reactions, occurring in up to 50% of patients. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient. Isolated cases of urticaria, rhinorrhea, dermatitis, and rarely anaphylaxis, angioedema, tongue edema, and face edema have been reported which may represent allergic reactions.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY GaviLyte- C with flavor pack cleanses the bowel by induction of diarrhea. The osmotic activity of polyethylene glycol 3350, in combination with the electrolyte concentration, results in virtually no net absorption or excretion of ions or water. Accordingly, large volumes may be administered without significant changes in fluid and electrolyte balance.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED GaviLyte- C with flavor pack is supplied in 4 liter bottles with an attached lemon flavor pack. Each 4 liter bottle contains polyethylene glycol-3350 240 g, sodium chloride 5.84 g, potassium chloride 2.98 g, sodium bicarbonate 6.72 g, sodium sulfate (anhydrous) 22.72 g. This preparation is supplied in powdered form, for oral administration as a solution.
GaviLyte- C with flavor pack 4liter: NDC 43386-060-19 Store at 20° to 25°C (68° to 77°F): excursions permitted between 15° to 30°C (59° to 86°F). KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS.
DISCARD UNUSED PORTION. LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc. Manufactured by: Novel Laboratories, Inc.
Somerset, NJ 08873, USA Manufactured for: Lupin Pharmaceuticals, Inc. Naples FL, 34108 SAP Code: 278922 Rev. 11/2024 Image
📋 Description ▾
DESCRIPTION GaviLyte- C with flavor pack is a white, colon lavage preparation provided as water-soluble components for solution. In solution this preparation with lemon flavor pack added delivers the following, in grams per liter. Polyethylene glycol 3350 240.00 Sodium chloride
5.84 Potassium chloride
6.72 Sodium bicarbonate
2.98 Sodium sulfate
22.72Flavor ingredients 0.500 When dissolved in sufficient water to make 4 liters, the final solution contains 125 mEq/L sodium, 10 mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L sulfate, 35 mEq/L chloride and 18 mEq/L polyethylene glycol 3350. The reconstituted solution is an isosmotic solution, for oral administration, having mild salty taste. This preparation can be used without the lemon flavor pack and is administered orally or via nasogastric tube.
Each lemon flavor pack (2 g) contains natural lemon flavor powder, saccharin sodium, maltodextrin.
⚠️ Precautions ▾
PRECAUTIONS General Patients with impaired gag reflex, unconscious or semiconscious patients and patients prone to regurgitation or aspiration should be observed during the administration of GaviLyte- C with flavor pack, especially if it is administered via nasogastric tube. If gastrointestinal obstruction or perforation is suspected appropriate studies should be performed to rule out these conditions before administration of GaviLyte- C with flavor pack. INFORMATION FOR PATIENTS GaviLyte- C with flavor pack produces a watery stool which cleanses the bowel prior to examination.
For best results, no solid food should be ingested during the 3 to 4 hour period prior to the initiation of GaviLyte- C with flavor pack administration. In no case should solid foods be eaten within 2 hours of drinking GaviLyte- C with flavor pack. The rate of administration is 240 mL (8 fl. oz.) every 10 minutes.
Rapid drinking of each portion is preferred rather than drinking small amounts continuously. The first bowel movement should occur approximately one hour after the start of GaviLyte- C with flavor pack administration. Administration of GaviLyte- C with flavor pack should be continued until the watery stool is clear and free of solid matter.
This normally requires the consumption of approximately 3 to 4 liters (3 to 4 quarts), although more or less may be required in some patients. The unused portion should be discarded. DRUG INTERACTIONS Oral medication administered within one hour of start of administration of GaviLyte- C with flavor pack may be flushed from the gastrointestinal tract and not absorbed.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY Studies to evaluate carcinogenic or mutagenic potential or potential to adversely affect male or female fertility have not been performed. PREGNANCY Category C. Animal reproduction studies have not been conducted with GaviLyte- C with flavor pack, and it is not known whether GaviLyte- C with flavor pack can affect reproductive capacity or harm the fetus when administered to a pregnant patient.
GaviLyte- C with flavor pack should be given to a pregnant patient only if clearly needed. PEDIATRIC USE Safety and effectiveness in pediatric patients have not been established. GERIATRIC USE Published literature contains isolated reports of serious adverse reactions following the administration of PEG-ELS 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" infiltrate on chest x-ray after vomiting and aspirating PEG.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Gavilyte-C with Flavor Pack (PEG-3350 (240g) and electrolytes for oral solution, USP) with flavor pack Label Lemon Flavor Pack Label lemon flavor