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Polyethylene Glycol 3350, NF Powder for Solution, Laxative
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Polyethylene Glycol 3350 | 17 g/d | 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 |
|---|---|---|---|---|---|---|---|
| 090812-001 | POLYETHYLENE GLYCOL 3350 | FOR SOLUTION | POLYETHYLENE GLYCOL 3350 | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | October 7, 2009 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250304). 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 d o 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 the top of white section in cap which is marked to indicate the correct dose (17g) 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 Manufactured by: LGM Pharma Solutions, LLC Irvine, CA 92614 7116-0 119 -99- EC -PD Rev. 01/2022 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.
Do Not Use
openFDA Drug LabelingDo not use if you have kidney disease, except under the advice and supervision of a doctor Manufactured by: LGM Pharma Solutions, LLC Irvine, CA 92614 7116-0 119 -99- EC -PD Rev. 01/2022
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 I ngredient (in each dose) Polyethylene Glycol 3350, 17 g (cap filled to the top)
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 |
|---|---|---|---|---|
| 79739-7116-1 | 79739-7116 | LGM PHARMA SOLUTIONS, LLC | 7 d in 1 BOTTLE (79739-7116-1) | October 7, 2009 |
| 79739-7116-2 | 79739-7116 | LGM PHARMA SOLUTIONS, LLC | 14 d in 1 BOTTLE (79739-7116-2) | October 7, 2009 |
| 79739-7116-3 | 79739-7116 | LGM PHARMA SOLUTIONS, LLC | 30 d in 1 BOTTLE (79739-7116-3) | October 7, 2009 |
| 45861-083-05 | 45861-083 | Pharmaceutica North America, Inc. | 238 d in 1 BOTTLE (45861-083-05) | February 10, 2025 |
| 45861-083-06 | 45861-083 | Pharmaceutica North America, Inc. | 2 BOTTLE in 1 BOX (45861-083-06) / 476 d in 1 BOTTLE | February 10, 2025 |
| 79739-7116 | 79739-7116 | LGM PHARMA SOLUTIONS, LLC | — | October 7, 2009 |
| 45861-083 | 45861-083 | Pharmaceutica North America, Inc. | — | February 10, 2025 |
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.