Polyethylene Glycol 3350
Powder, For Solution · Oral
Active ingredient
Active ingredient (in each dose) Polyethylene Glycol 3350, 17 g
Purpose
Purpose Osmotic Laxative
Uses
Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
Warnings
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.
Do not use
Do not use if you have kidney disease, except under the advice and supervision of a doctor
Ask a doctor before use
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
Ask a doctor or pharmacist before use if you are taking a prescription drug
When using this product
When using this product you may have loose, watery, more frequent stools
Stop use and ask a doctor
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
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Directions do not take more than directed unless advised by your doctor adults and children 17 years of age and older: use once a day stir and dissolve one packet of powder (17 g) 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
Other information store at 20°-25°C (68°-77°F) tamper-evident: do not use if foil is open or broken
Inactive ingredients
Inactive ingredients none
Questions?
Questions or comments? Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
Label text from the FDA structured product label by L.N.K. International, Inc. (revised Sep 10, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Polyethylene Glycol 3350 in 29 products
- Polyethylene Glycol 3500 in 1 product
Polyethylene Glycol 3350 NDC products (30)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-2430 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | A-S Medication Solutions | ANDA |
| 60687-431 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | American Health Packaging | ANDA |
| 62559-157 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | ANI Pharmaceuticals, Inc. | ANDA |
| 84386-125 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Aurobindo Pharma Limited | ANDA |
| 58602-805 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Aurohealth LLC | ANDA |
| 68001-607 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | BluePoint Laboratories | ANDA |
| 72162-2180 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Bryant Ranch Prepack | ANDA |
| 72162-2172 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Bryant Ranch Prepack | ANDA |
| 69230-324 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Camber Consumer Care Inc | ANDA |
| 55154-8184 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Cardinal Health 107, LLC | ANDA |
| 55154-8091 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Cardinal Health 107, LLC | ANDA |
| 55154-8090 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Cardinal Health 107, LLC | ANDA |
| 55154-2328 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Cardinal Health 107, LLC | ANDA |
| 70000-0699 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | CARDINAL HEALTH 110, LLC. DBA LEADER | ANDA |
| 83324-002 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | CHAIN DRUG MARKETING ASSOCIATION, INC. | ANDA |
| 57896-489 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Geri-Care Pharmaceutical Corp | ANDA |
| 57896-490 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Gericare Pharmaceuticals | ANDA |
| 72657-196 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | GLENMARK THERAPEUTICS INC., USA | ANDA |
| 81033-762 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Kesin Pharma Corporation | ANDA |
| 50844-772 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | L.N.K. International, Inc. | ANDA |
| 0904-6931 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Major Pharmaceuticals | ANDA |
| 51079-306 | Polyethylene Glycol 3500 17 g/17g Powder, For Solution | Mylan Institutional Inc. | ANDA |
| 72603-302 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | NorthStar Rx LLC | ANDA |
| 45802-868 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 72090-036 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | PIONEER LIFE SCIENCES, LLC | ANDA |
| 68788-8601 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Preferred Pharmaceuticals Inc. | ANDA |
| 63739-760 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | SKY Packaging | ANDA |
| 51672-2104 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | Sun Pharmaceutical Industries, Inc. | ANDA |
| 87362-119 | Polyethylene Glycol 3350 17 g/17g Powder, For Solution | The Fresh Test, LLC | ANDA |
| 73581-913 | Polyethylene Glycol 3350 17 g/1 Powder, For Solution | YYBA Corp | ANDA |
Polyethylene Glycol 3350 recalls
- D-0544-2021 Jun 2, 2021 · Class II · Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - D-0545-2021 Jun 2, 2021 · Class II · Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Frequently asked questions
What is Polyethylene Glycol 3350 used for?
Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
Who makes Polyethylene Glycol 3350?
Polyethylene Glycol 3350 is listed by 26 labelers in the FDA NDC directory, including A-S Medication Solutions, American Health Packaging, ANI Pharmaceuticals, Inc., Aurobindo Pharma Limited.
Has Polyethylene Glycol 3350 been recalled?
The FDA enforcement database lists 2 recalls for Polyethylene Glycol 3350, most recently D-0544-2021 (class ii): CGMP Deviations: Intermittent exposure to temperature excursion during storage.