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GAVILAX
Polyethylene Glycol 3350 · Powder, for Solution
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Polyethylene Glycol 3350 | 17 g/17g | 876193 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Osmotic Activity [MoA] | MoA | All 105 members |
| Osmotic Laxative [EPC] | EPC | All 103 members |
| Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] | PE | All 53 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 091077-001 | POLYETHYLENE GLYCOL 3350 | FOR SOLUTION | POLYETHYLENE GLYCOL 3350 | Over-the-counter | — | ||
| 091077-002 | POLYETHYLENE GLYCOL 3350 | FOR SOLUTION | POLYETHYLENE GLYCOL 3350 | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 8 | Labeling | Approved | April 3, 2020 | Standard |
| Supplement | 3 | Labeling | Approved | June 27, 2011 | — |
| Original application | 1 | Approved | October 6, 2009 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260504). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingDirections do not take more than directed unless advised by your doctor the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line. adults and children 17 years of age and older: use once a day fill to top of line in cap which is marked to indicate the correct dose (17 g) stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink do not combine with starch-based thickeners used for difficulty swallowing ensure that the powder is fully dissolved before drinking do not drink if there are any clumps do not use more than 7 days children 16 years of age or under: ask a doctor Other Information store at 20°- 25°C (68°– 77°F) tamper-evident: do not use if printed foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
Purpose
openFDA Drug LabelingPurpose Osmotic Laxative Use • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days
Dosage and Administration
openFDA Drug LabelingStop use and ask a doctor if • you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition. • you get diarrhea • you need to use a laxative for longer than 1 week If pregnant or breast-feeding, ask a health professional before use.
Warnings
openFDA Drug LabelingWARNINGS Allergy alert: Do not use if you are allergic to polyethylene glycol Do not use if you have kidney disease, except under the advice and supervision of a doctor
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if you have • nausea, vomiting or abdominal pain • a sudden change in bowel habits that lasts over 2 weeks • irritable bowel syndrome Ask a doctor or pharmacist before use if you are taking a prescription drug When using this product you may have loose, watery, more frequent stools
Active Ingredient
openFDA Drug LabelingActive Ingredient Polyethylene Glycol 3350, 17 g (cap filled to line)........................Osmotic Laxative
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: POLYETHYLENE GLYCOL 3350. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-5310-0 | 50090-5310 | A-S Medication Solutions | 238 g in 1 BOTTLE (50090-5310-0) | October 28, 2020 |
| 17856-0312-1 | 17856-0312 | ATLANTIC BIOLOGICALS CORP. | 17 g in 1 BAG (17856-0312-1) | January 26, 2021 |
| 17856-0312-2 | 17856-0312 | ATLANTIC BIOLOGICALS CORP. | 8.5 g in 1 BAG (17856-0312-2) | January 26, 2021 |
| 17856-0312-3 | 17856-0312 | ATLANTIC BIOLOGICALS CORP. | 17 g in 1 CUP (17856-0312-3) | January 26, 2021 |
| 17856-0312-4 | 17856-0312 | ATLANTIC BIOLOGICALS CORP. | 4 g in 1 BAG (17856-0312-4) | January 26, 2021 |
| 17856-0312-5 | 17856-0312 | ATLANTIC BIOLOGICALS CORP. | 50 CUP in 1 CASE (17856-0312-5) / 8.5 g in 1 CUP | January 26, 2021 |
| 17856-0312-6 | 17856-0312 | ATLANTIC BIOLOGICALS CORP. | 72 POUCH in 1 CASE (17856-0312-6) / 4.5 g in 1 POUCH | January 26, 2021 |
| 17856-0312-7 | 17856-0312 | ATLANTIC BIOLOGICALS CORP. | 50 BAG in 1 BOX, UNIT-DOSE (17856-0312-7) / 4.25 g in 1 BAG | October 10, 2023 |
| 17856-0312-8 | 17856-0312 | ATLANTIC BIOLOGICALS CORP. | 72 BAG in 1 BOX, UNIT-DOSE (17856-0312-8) / 4.25 g in 1 BAG | July 22, 2025 |
| 17856-0312-9 | 17856-0312 | ATLANTIC BIOLOGICALS CORP. | 50 CUP in 1 BOX, UNIT-DOSE (17856-0312-9) / 4.25 g in 1 CUP | July 22, 2025 |
| 17856-0310-1 | 17856-0310 | Atlantic Biologicals Corp. | 50 CUP, UNIT-DOSE in 1 CASE (17856-0310-1) / 2 g in 1 CUP, UNIT-DOSE | June 1, 2026 |
| 17856-0310-2 | 17856-0310 | Atlantic Biologicals Corp. | 72 POUCH in 1 CASE (17856-0310-2) / 2 g in 1 POUCH | March 3, 2026 |
| 43386-312-08 | 43386-312 | Lupin Pharmaceuticals,Inc. | 238 g in 1 BOTTLE (43386-312-08) | October 9, 2009 |
| 43386-312-14 | 43386-312 | Lupin Pharmaceuticals,Inc. | 510 g in 1 BOTTLE (43386-312-14) | October 9, 2009 |
| 68788-7508-2 | 68788-7508 | Preferred Pharmaceuticals, Inc. | 238 g in 1 BOTTLE (68788-7508-2) | October 28, 2019 |
| 63187-368-23 | 63187-368 | Proficient Rx LP | 238 g in 1 BOTTLE (63187-368-23) | September 1, 2016 |
| 50090-5310 | 50090-5310 | A-S Medication Solutions | — | October 9, 2009 |
| 17856-0312 | 17856-0312 | ATLANTIC BIOLOGICALS CORP. | — | January 26, 2021 |
| 17856-0310 | 17856-0310 | Atlantic Biologicals Corp. | — | October 9, 2009 |
| 43386-312 | 43386-312 | Lupin Pharmaceuticals,Inc. | — | October 9, 2009 |
| 68788-7508 | 68788-7508 | Preferred Pharmaceuticals, Inc. | — | October 9, 2009 |
| 63187-368 | 63187-368 | Proficient Rx LP | — | October 9, 2009 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.