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basic care clearlax
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 |
|---|---|---|---|---|---|---|---|
| 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| 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 LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20221208). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days
Purpose
openFDA Drug LabelingPurpose Osmotic Laxative
Dosage and Administration
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 (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 more than 7 days • children 16 years of age or under: ask a doctor
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 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
openFDA Drug LabelingDo 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
Stop Use
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
Active Ingredient
openFDA Drug LabelingActive ingredient (in each dose) Polyethylene Glycol 3350, 17 g (cap filled to line)
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 |
|---|---|---|---|---|
| 72288-020-02 | 72288-020 | Amazon.com Services LLC | 238 g in 1 BOTTLE (72288-020-02) | November 28, 2022 |
| 72288-020-03 | 72288-020 | Amazon.com Services LLC | 510 g in 1 BOTTLE (72288-020-03) | November 28, 2022 |
| 72288-020-09 | 72288-020 | Amazon.com Services LLC | 765 g in 1 BOTTLE (72288-020-09) | November 28, 2022 |
| 72288-499-02 | 72288-499 | Amazon.com Services LLC | 238 g in 1 BOTTLE (72288-499-02) | March 16, 2021 |
| 72288-499-03 | 72288-499 | Amazon.com Services LLC | 510 g in 1 BOTTLE (72288-499-03) | August 26, 2020 |
| 72288-499-09 | 72288-499 | Amazon.com Services LLC | 765 g in 1 BOTTLE (72288-499-09) | June 22, 2020 |
| 72288-499-78 | 72288-499 | Amazon.com Services LLC | 100 POUCH in 1 CARTON (72288-499-78) / 17 g in 1 POUCH | May 27, 2022 |
| 72288-020 | 72288-020 | Amazon.com Services LLC | — | November 28, 2022 |
| 72288-499 | 72288-499 | Amazon.com Services LLC | — | June 22, 2020 |
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.