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CLEARLAX

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
CLEARLAX
Generic name
Polyethylene Glycol 3350
Dosage form
Powder, for Solution
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Amazon.com Services LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
7
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
23

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
090685
Application type
ANDA · Abbreviated New Drug Application
Approval date
October 6, 2009
Sponsor
PPI-DAC
Products on application
2
Submissions recorded
8
Products approved under application 090685.
Product Trade name Form Strength Ingredient Status TE Flags
090685-001 POLYETHYLENE GLYCOL 3350 FOR SOLUTION POLYETHYLENE GLYCOL 3350 Over-the-counter —
090685-002 POLYETHYLENE GLYCOL 3350 FOR SOLUTION POLYETHYLENE GLYCOL 3350 Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 090685.
Type No. Action Status Date Review
Supplement 19 Manufacturing (CMC) Approved August 18, 2026 Unknown
Supplement 14 Manufacturing (CMC) Approved June 16, 2022 Unknown
Supplement 13 Labeling Approved October 13, 2021 Standard
Supplement 11 Labeling Approved October 13, 2021 Standard
Supplement 9 Manufacturing (CMC) Approved October 11, 2019 Unknown
Supplement 3 Labeling Approved January 12, 2016 Standard
Supplement 2 Labeling Approved February 6, 2013 —
Original application 1 Approved October 6, 2009 —

Review documents

  • 0 · Original application · October 14, 2009

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260908). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260908 HUMAN OTC DRUG · 20250611 HUMAN OTC DRUG · 20230215

Indications and Usage

openFDA Drug Labeling

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

Purpose Osmotic Laxative

Dosage and Administration

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 (white section in cap) • adults and children 17 years of age and older: • use once a day • fill to top of white section 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 no more than 7 days • children 16 years of age or under: ask a doctor

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 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 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

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

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each dose) Polyethylene Glycol 3350, 17 grams (cap filled to the indicated “17 GRAMS” line)

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
72288-033-02 72288-033 Amazon.com Services LLC 238 g in 1 BOTTLE (72288-033-02) July 16, 2026
72288-033-03 72288-033 Amazon.com Services LLC 510 g in 1 BOTTLE (72288-033-03) July 2, 2026
72288-033-09 72288-033 Amazon.com Services LLC 765 g in 1 BOTTLE (72288-033-09) August 27, 2026
72288-033-78 72288-033 Amazon.com Services LLC 100 PACKET in 1 CARTON (72288-033-78) / 17 g in 1 PACKET (72288-033-00) September 8, 2026
72288-471-09 72288-471 Amazon.com Services LLC 765 g in 1 BOTTLE (72288-471-09) August 27, 2026
59640-797-02 59640-797 H E B 238 g in 1 BOTTLE (59640-797-02) January 17, 2023
59640-797-03 59640-797 H E B 510 g in 1 BOTTLE (59640-797-03) January 17, 2023
79481-0090-0 79481-0090 Meijer, Inc. 238 g in 1 BOTTLE (79481-0090-0) January 30, 2024
79481-0090-3 79481-0090 Meijer, Inc. 510 g in 1 BOTTLE (79481-0090-3) January 13, 2023
56062-306-02 56062-306 Publix Super Markets Inc 238 g in 1 BOTTLE (56062-306-02) December 14, 2009
56062-306-03 56062-306 Publix Super Markets Inc 510 g in 1 BOTTLE (56062-306-03) December 14, 2009
56062-306-04 56062-306 Publix Super Markets Inc 850 g in 1 BOTTLE (56062-306-04) March 13, 2019
70677-1068-1 70677-1068 STRATEGIC SOURCING SERVICES LLC 238 g in 1 BOTTLE (70677-1068-1) August 1, 2023
21130-637-02 21130-637 Safeway 238 g in 1 BOTTLE (21130-637-02) March 6, 2026
21130-637-03 21130-637 Safeway 510 g in 1 BOTTLE (21130-637-03) July 1, 2026
21130-637-09 21130-637 Safeway 765 g in 1 BOTTLE (21130-637-09) May 1, 2026
72288-033 72288-033 Amazon.com Services LLC — July 2, 2026
72288-471 72288-471 Amazon.com Services LLC — August 27, 2026
59640-797 59640-797 H E B — January 17, 2023
79481-0090 79481-0090 Meijer, Inc. — January 13, 2023
56062-306 56062-306 Publix Super Markets Inc — December 14, 2009
70677-1068 70677-1068 STRATEGIC SOURCING SERVICES LLC — August 1, 2023
21130-637 21130-637 Safeway — March 6, 2026

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.