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Polyethylene Glycol 3350
Overview
Active ingredients
Source: NDC DirectoryForms, 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 |
|---|---|---|---|---|---|---|---|
| 203928-001 | POLYETHYLENE GLYCOL 3350 | FOR SOLUTION | POLYETHYLENE GLYCOL 3350 | Over-the-counter | — | ||
| 203928-002 | 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 | September 11, 2026 | Unknown |
| Supplement | 11 | Labeling | Approved | February 8, 2023 | Standard |
| Supplement | 5 | Labeling | Approved | February 8, 2023 | Standard |
| Original application | 1 | Approved | August 24, 2016 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260910). This is the manufacturer's labelling text, not a summary and not advice.
Recent Major Changes
openFDA Drug LabelingCarton-100pkt
Indications and Usage
openFDA Drug LabelingUses • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days
Purpose
openFDA Drug LabelingActive ingredient (in each dose) (Packet Only) Polyethylene Glycol 3350, 17 g
Dosage and Administration
openFDA Drug LabelingDirections (Can Only) • 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: o use once a day o fill to top of white section in cap which is marked to indicate the correct dose (17 g) o stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink o do not combine with starch-based thickeners used for difficulty swallowing o ensure that the powder is fully dissolved before drinking o do not drink if there are any clumps o do not use more than 7 days • children 16 years of age or under: ask a doctor Directions (Packet Only) • do not take more than directed unless advised by your doctor • adults and children 17 years of age and older: o use once a day o stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink o do not combine with starch-based thickeners used for difficulty swallowing o ensure that the powder is fully dissolved before drinking o do not drink if there are any clumps o 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) (Bottle Only) Polyethylene Glycol 3350, 17 g (cap filled to line) (Packet Only) Polyethylene Glycol 3350, 17 g
Overdosage
openFDA Drug LabelingIn case of overdose, get medical help or contact a Poison Control Center right away.
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Polyethylene Glycol 3350 17g of white powder when filled to the indicated line (white section in cap). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep Tightly Closed Dispense in a tight, light-resistant container as defined in the USP. NDC: 72162-2172-2: 238 g Powder for Solution NDC: 72162-2172-4: 510 g Powder for Solution Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
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.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class II | June 2, 2021 | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated |
| Class II | June 2, 2021 | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-2430-0 | 50090-2430 | A-S Medication Solutions | 238 g in 1 BOTTLE (50090-2430-0) | July 5, 2016 |
| 62559-157-10 | 62559-157 | ANI Pharmaceuticals, Inc. | 100 PACKET in 1 CARTON (62559-157-10) / 17 g in 1 PACKET (62559-157-17) | March 24, 2020 |
| 62559-157-30 | 62559-157 | ANI Pharmaceuticals, Inc. | 30 PACKET in 1 CARTON (62559-157-30) / 17 g in 1 PACKET (62559-157-17) | March 24, 2020 |
| 60687-431-27 | 60687-431 | American Health Packaging | 30 POUCH in 1 CARTON (60687-431-27) / 17 g in 1 POUCH (60687-431-99) | November 21, 2023 |
| 60687-431-92 | 60687-431 | American Health Packaging | 100 POUCH in 1 CARTON (60687-431-92) / 17 g in 1 POUCH (60687-431-99) | February 26, 2020 |
| 60687-431-98 | 60687-431 | American Health Packaging | 14 POUCH in 1 CARTON (60687-431-98) / 17 g in 1 POUCH (60687-431-99) | May 29, 2019 |
| 59651-876-25 | 59651-876 | Aurobindo Pharma Limited | 25000 g in 1 BAG (59651-876-25) | April 23, 2024 |
| 84386-125-08 | 84386-125 | Aurobindo Pharma Limited | 119 g in 1 BOTTLE, PLASTIC (84386-125-08) | January 7, 2026 |
| 84386-125-14 | 84386-125 | Aurobindo Pharma Limited | 14 PACKET in 1 CARTON (84386-125-14) / 17 g in 1 PACKET | January 7, 2026 |
| 84386-125-24 | 84386-125 | Aurobindo Pharma Limited | 238 g in 1 BOTTLE, PLASTIC (84386-125-24) | January 7, 2026 |
| 84386-125-54 | 84386-125 | Aurobindo Pharma Limited | 510 g in 1 BOTTLE, PLASTIC (84386-125-54) | January 7, 2026 |
| 58602-805-01 | 58602-805 | Aurohealth LLC | 119 g in 1 BOTTLE, PLASTIC (58602-805-01) | April 9, 2018 |
| 58602-805-02 | 58602-805 | Aurohealth LLC | 238 g in 1 BOTTLE, PLASTIC (58602-805-02) | April 9, 2018 |
| 58602-805-03 | 58602-805 | Aurohealth LLC | 510 g in 1 BOTTLE, PLASTIC (58602-805-03) | April 9, 2018 |
| 58602-805-04 | 58602-805 | Aurohealth LLC | 850 g in 1 BOTTLE, PLASTIC (58602-805-04) | April 9, 2018 |
| 58602-805-25 | 58602-805 | Aurohealth LLC | 765 g in 1 BOTTLE, PLASTIC (58602-805-25) | April 23, 2024 |
| 58602-805-27 | 58602-805 | Aurohealth LLC | 14 PACKET in 1 CARTON (58602-805-27) / 17 g in 1 PACKET | April 23, 2024 |
| 68001-607-55 | 68001-607 | BluePoint Laboratories | 238 g in 1 BOTTLE (68001-607-55) | October 1, 2023 |
| 68001-607-69 | 68001-607 | BluePoint Laboratories | 510 g in 1 BOTTLE (68001-607-69) | October 1, 2023 |
| 72162-2172-2 | 72162-2172 | Bryant Ranch Prepack | 238 g in 1 BOTTLE (72162-2172-2) | January 23, 2024 |
| 72162-2172-4 | 72162-2172 | Bryant Ranch Prepack | 510 g in 1 BOTTLE (72162-2172-4) | January 23, 2024 |
| 72162-2180-2 | 72162-2180 | Bryant Ranch Prepack | 238 g in 1 BOTTLE (72162-2180-2) | February 2, 2024 |
| 72162-2180-4 | 72162-2180 | Bryant Ranch Prepack | 510 g in 1 BOTTLE (72162-2180-4) | February 2, 2024 |
| 70000-0699-2 | 70000-0699 | CARDINAL HEALTH 110, LLC. DBA LEADER | 10 PACKET in 1 CARTON (70000-0699-2) / 17 g in 1 PACKET (70000-0699-1) | November 8, 2024 |
| 83324-002-08 | 83324-002 | CHAIN DRUG MARKETING ASSOCIATION, INC. | 238 g in 1 BOTTLE (83324-002-08) | March 1, 2024 |
| 83324-002-16 | 83324-002 | CHAIN DRUG MARKETING ASSOCIATION, INC. | 510 g in 1 BOTTLE (83324-002-16) | March 1, 2024 |
| 69230-324-32 | 69230-324 | Camber Consumer Care Inc | 7 PACKET in 1 CARTON (69230-324-32) / 17 g in 1 PACKET | April 14, 2021 |
| 69230-324-33 | 69230-324 | Camber Consumer Care Inc | 10 PACKET in 1 CARTON (69230-324-33) / 17 g in 1 PACKET | April 14, 2021 |
| 69230-324-34 | 69230-324 | Camber Consumer Care Inc | 119 g in 1 BOTTLE (69230-324-34) | April 14, 2021 |
| 69230-324-35 | 69230-324 | Camber Consumer Care Inc | 238 g in 1 BOTTLE (69230-324-35) | April 14, 2021 |
| 69230-324-36 | 69230-324 | Camber Consumer Care Inc | 510 g in 1 BOTTLE (69230-324-36) | April 14, 2021 |
| 69230-324-37 | 69230-324 | Camber Consumer Care Inc | 14 PACKET in 1 CARTON (69230-324-37) / 17 g in 1 PACKET | April 14, 2021 |
| 69230-324-38 | 69230-324 | Camber Consumer Care Inc | 100 PACKET in 1 CARTON (69230-324-38) / 17 g in 1 PACKET | April 21, 2025 |
| 69230-324-39 | 69230-324 | Camber Consumer Care Inc | 765 g in 1 BOTTLE (69230-324-39) | January 3, 2025 |
| 69230-324-40 | 69230-324 | Camber Consumer Care Inc | 40 PACKET in 1 CARTON (69230-324-40) / 17 g in 1 PACKET | April 21, 2025 |
| 55154-2328-5 | 55154-2328 | Cardinal Health 107, LLC | 7 PACKET in 1 BAG (55154-2328-5) / 17 g in 1 PACKET | June 30, 2019 |
| 55154-8090-5 | 55154-8090 | Cardinal Health 107, LLC | 5 POUCH in 1 BAG (55154-8090-5) / 17 g in 1 POUCH | June 30, 2019 |
| 55154-8091-5 | 55154-8091 | Cardinal Health 107, LLC | 5 POUCH in 1 BAG (55154-8091-5) / 17 g in 1 POUCH | June 30, 2019 |
| 55154-8184-5 | 55154-8184 | Cardinal Health 107, LLC | 7 POUCH in 1 BAG (55154-8184-5) / 17 g in 1 POUCH | April 15, 2019 |
| 72657-196-16 | 72657-196 | GLENMARK THERAPEUTICS INC., USA | 765 g in 1 CAN (72657-196-16) | September 19, 2024 |
| 57896-489-14 | 57896-489 | Geri-Care Pharmaceutical Corp | 238 g in 1 BOTTLE (57896-489-14) | July 1, 2016 |
| 57896-489-30 | 57896-489 | Geri-Care Pharmaceutical Corp | 510 g in 1 BOTTLE (57896-489-30) | July 1, 2016 |
| 57896-490-03 | 57896-490 | Gericare Pharmaceuticals | 30 PACKET in 1 CARTON (57896-490-03) / 17 g in 1 PACKET (57896-490-01) | October 27, 2022 |
| 57896-490-07 | 57896-490 | Gericare Pharmaceuticals | 119 g in 1 CAN (57896-490-07) | October 27, 2022 |
| 57896-490-14 | 57896-490 | Gericare Pharmaceuticals | 238 g in 1 CAN (57896-490-14) | October 27, 2022 |
| 57896-490-30 | 57896-490 | Gericare Pharmaceuticals | 510 g in 1 CAN (57896-490-30) | October 27, 2022 |
| 57896-490-45 | 57896-490 | Gericare Pharmaceuticals | 765 g in 1 CAN (57896-490-45) | October 27, 2022 |
| 81033-762-01 | 81033-762 | Kesin Pharma Corporation | 100 PACKET in 1 CARTON (81033-762-01) / 17 g in 1 PACKET (81033-762-17) | June 9, 2025 |
| 81033-762-14 | 81033-762 | Kesin Pharma Corporation | 14 PACKET in 1 CARTON (81033-762-14) / 17 g in 1 PACKET (81033-762-17) | June 9, 2025 |
| 81033-762-30 | 81033-762 | Kesin Pharma Corporation | 30 PACKET in 1 CARTON (81033-762-30) / 17 g in 1 PACKET (81033-762-17) | June 9, 2025 |
| 50844-772-01 | 50844-772 | L.N.K. International, Inc. | 30 PACKET in 1 CARTON (50844-772-01) / 17 g in 1 PACKET | September 10, 2026 |
| 50844-772-03 | 50844-772 | L.N.K. International, Inc. | 10 PACKET in 1 CARTON (50844-772-03) / 17 g in 1 PACKET | September 10, 2026 |
| 50844-772-09 | 50844-772 | L.N.K. International, Inc. | 20 PACKET in 1 CARTON (50844-772-09) / 17 g in 1 PACKET | September 10, 2026 |
| 50844-772-12 | 50844-772 | L.N.K. International, Inc. | 100 PACKET in 1 CARTON (50844-772-12) / 17 g in 1 PACKET | September 10, 2026 |
| 50844-772-43 | 50844-772 | L.N.K. International, Inc. | 17 g in 1 PACKET (50844-772-43) | September 10, 2026 |
| 50844-772-48 | 50844-772 | L.N.K. International, Inc. | 14 PACKET in 1 CARTON (50844-772-48) / 17 g in 1 PACKET | September 10, 2026 |
| 50844-772-49 | 50844-772 | L.N.K. International, Inc. | 238 g in 1 BOTTLE, PLASTIC (50844-772-49) | September 10, 2026 |
| 50844-772-90 | 50844-772 | L.N.K. International, Inc. | 510 g in 1 BOTTLE, PLASTIC (50844-772-90) | September 10, 2026 |
| 50844-772-92 | 50844-772 | L.N.K. International, Inc. | 119 g in 1 BOTTLE, PLASTIC (50844-772-92) | September 10, 2026 |
| 50844-772-93 | 50844-772 | L.N.K. International, Inc. | 578 g in 1 BOTTLE, PLASTIC (50844-772-93) | September 10, 2026 |
| 0904-6931-26 | 0904-6931 | Major Pharmaceuticals | 14 PACKET in 1 CARTON (0904-6931-26) / 17 g in 1 PACKET | June 30, 2019 |
| 0904-6931-76 | 0904-6931 | Major Pharmaceuticals | 30 PACKET in 1 CARTON (0904-6931-76) / 17 g in 1 PACKET | June 30, 2019 |
| 0904-6931-81 | 0904-6931 | Major Pharmaceuticals | 100 PACKET in 1 CARTON (0904-6931-81) / 17 g in 1 PACKET | June 30, 2019 |
| 0904-6931-86 | 0904-6931 | Major Pharmaceuticals | 17 g in 1 PACKET (0904-6931-86) | June 30, 2019 |
| 72603-302-02 | 72603-302 | NorthStar Rx LLC | 14 PACKET in 1 CARTON (72603-302-02) / 17 g in 1 PACKET (72603-302-01) | April 1, 2025 |
| 72603-302-03 | 72603-302 | NorthStar Rx LLC | 30 PACKET in 1 CARTON (72603-302-03) / 17 g in 1 PACKET (72603-302-01) | April 1, 2025 |
| 72603-302-04 | 72603-302 | NorthStar Rx LLC | 100 PACKET in 1 CARTON (72603-302-04) / 17 g in 1 PACKET (72603-302-01) | April 1, 2025 |
| 72090-036-01 | 72090-036 | PIONEER LIFE SCIENCES, LLC | 30 PACKET in 1 CARTON (72090-036-01) / 17 g in 1 PACKET | March 5, 2025 |
| 72090-036-02 | 72090-036 | PIONEER LIFE SCIENCES, LLC | 100 PACKET in 1 CARTON (72090-036-02) / 17 g in 1 PACKET | March 5, 2025 |
| 72090-036-03 | 72090-036 | PIONEER LIFE SCIENCES, LLC | 10 PACKET in 1 CARTON (72090-036-03) / 17 g in 1 PACKET | April 8, 2026 |
| 45802-868-01 | 45802-868 | Padagis Israel Pharmaceuticals Ltd | 119 g in 1 BOTTLE (45802-868-01) | November 6, 2009 |
| 45802-868-02 | 45802-868 | Padagis Israel Pharmaceuticals Ltd | 238 g in 1 BOTTLE (45802-868-02) | November 4, 2009 |
| 45802-868-03 | 45802-868 | Padagis Israel Pharmaceuticals Ltd | 510 g in 1 BOTTLE (45802-868-03) | November 5, 2009 |
| 45802-868-66 | 45802-868 | Padagis Israel Pharmaceuticals Ltd | 14 PACKET in 1 CARTON (45802-868-66) / 17 g in 1 PACKET | July 16, 2018 |
| 68788-8601-2 | 68788-8601 | Preferred Pharmaceuticals Inc. | 238 g in 1 BOTTLE (68788-8601-2) | March 8, 2024 |
| 63739-760-04 | 63739-760 | SKY Packaging | 100 PACKET in 1 CARTON (63739-760-04) / 17 g in 1 PACKET (63739-760-01) | August 1, 2024 |
| 51672-2104-3 | 51672-2104 | Sun Pharmaceutical Industries, Inc. | 765 g in 1 CAN (51672-2104-3) | October 9, 2025 |
| 51672-2104-5 | 51672-2104 | Sun Pharmaceutical Industries, Inc. | 238 g in 1 CAN (51672-2104-5) | July 29, 2026 |
| 51672-2104-9 | 51672-2104 | Sun Pharmaceutical Industries, Inc. | 510 g in 1 CAN (51672-2104-9) | July 29, 2026 |
| 87362-119-01 | 87362-119 | The Fresh Test, LLC | 119 g in 1 CAN (87362-119-01) | July 20, 2026 |
| 73581-913-40 | 73581-913 | YYBA Corp | 40 PACKET in 1 CARTON (73581-913-40) / 17 POWDER, FOR SOLUTION in 1 PACKET | January 1, 2026 |
| 50090-2430 | 50090-2430 | A-S Medication Solutions | — | October 13, 2009 |
| 62559-157 | 62559-157 | ANI Pharmaceuticals, Inc. | — | March 24, 2020 |
| 60687-431 | 60687-431 | American Health Packaging | — | May 29, 2019 |
| 59651-876 | 59651-876 | Aurobindo Pharma Limited | — | April 23, 2024 |
| 84386-125 | 84386-125 | Aurobindo Pharma Limited | — | January 7, 2026 |
| 58602-805 | 58602-805 | Aurohealth LLC | — | April 9, 2018 |
| 68001-607 | 68001-607 | BluePoint Laboratories | — | October 1, 2023 |
| 72162-2172 | 72162-2172 | Bryant Ranch Prepack | — | October 13, 2009 |
| 72162-2180 | 72162-2180 | Bryant Ranch Prepack | — | May 1, 2014 |
| 70000-0699 | 70000-0699 | CARDINAL HEALTH 110, LLC. DBA LEADER | — | November 8, 2024 |
| 83324-002 | 83324-002 | CHAIN DRUG MARKETING ASSOCIATION, INC. | — | March 1, 2024 |
| 69230-324 | 69230-324 | Camber Consumer Care Inc | — | April 14, 2021 |
| 55154-2328 | 55154-2328 | Cardinal Health 107, LLC | — | June 30, 2019 |
| 55154-8090 | 55154-8090 | Cardinal Health 107, LLC | — | June 30, 2019 |
| 55154-8091 | 55154-8091 | Cardinal Health 107, LLC | — | June 30, 2019 |
| 55154-8184 | 55154-8184 | Cardinal Health 107, LLC | — | April 15, 2019 |
| 72657-196 | 72657-196 | GLENMARK THERAPEUTICS INC., USA | — | September 19, 2024 |
| 57896-489 | 57896-489 | Geri-Care Pharmaceutical Corp | — | May 1, 2014 |
| 57896-490 | 57896-490 | Gericare Pharmaceuticals | — | October 27, 2022 |
| 81033-762 | 81033-762 | Kesin Pharma Corporation | — | June 9, 2025 |
| 50844-772 | 50844-772 | L.N.K. International, Inc. | — | September 10, 2026 |
| 0904-6931 | 0904-6931 | Major Pharmaceuticals | — | June 30, 2019 |
| 72603-302 | 72603-302 | NorthStar Rx LLC | — | April 1, 2025 |
| 72090-036 | 72090-036 | PIONEER LIFE SCIENCES, LLC | — | March 5, 2025 |
| 45802-868 | 45802-868 | Padagis Israel Pharmaceuticals Ltd | — | October 13, 2009 |
| 68788-8601 | 68788-8601 | Preferred Pharmaceuticals Inc. | — | March 8, 2024 |
| 63739-760 | 63739-760 | SKY Packaging | — | August 1, 2024 |
| 51672-2104 | 51672-2104 | Sun Pharmaceutical Industries, Inc. | — | October 9, 2025 |
| 87362-119 | 87362-119 | The Fresh Test, LLC | — | July 20, 2026 |
| 73581-913 | 73581-913 | YYBA Corp | — | January 1, 2026 |
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 |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 11 sections on this page.