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GAVILAX

Polyethylene Glycol 3350 · Powder, for Solution

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
GAVILAX
Generic name
Polyethylene Glycol 3350
Dosage form
Powder, for Solution
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Atlantic Biologicals Corp.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
6
Packages
16
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Polyethylene Glycol 3350 17 g/17g 876193 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Powder, for Solution
Route of administration
Oral
Presentations
22

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
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
Application number
091077
Application type
ANDA · Abbreviated New Drug Application
Approval date
October 6, 2009
Sponsor
NOVEL LABS INC
Products on application
2
Submissions recorded
3
Products approved under application 091077.
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
Most recent submissions on application 091077.
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 —

Review documents

  • 0 · Original application · October 21, 2009
  • 0 · Original application · October 14, 2009

Prescribing information

Source: openFDA Drug Labeling

Reproduced 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.

HUMAN OTC DRUG · 20260504 HUMAN OTC DRUG · 20251208

Indications and Usage

openFDA Drug Labeling

Directions 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 Osmotic Laxative Use • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days

Dosage and Administration

openFDA Drug Labeling

Stop 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 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 Labeling

Ask 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 Labeling

Active Ingredient Polyethylene Glycol 3350, 17 g (cap filled to line)........................Osmotic Laxative

Adverse event reports

Source: openFDA FAERS
100,281
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed 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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
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

Every dataset that contributed a fact to 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.