Polyethylene Glycol 3350

Mechanism-of-action classes: Osmotic Activity; Unknown Cellular or Molecular Interaction.

• Use • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 daysICD-10: K59.00

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 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 powder is fully dissolved before drinking • do no drink if there are any clumps • do not use no more than 7 days • children 16 years of age or under: ask a doctor

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).

• Jul 13, 1984NDANDA019011Azurity
• Apr 22, 1991NDANDA019797Azurity
• Aug 2, 2006NDANDA021881Salix Pharms
• Oct 6, 2006NDANDA022015Bayer Healthcare Llc
• May 27, 2009ANDAANDA090019Novel Labs Inc
• Jun 1, 2009ANDAANDA090186Novel Labs Inc
• May 4, 2018NDANDA209381Salix
• Jun 15, 2023NDANDA215344Azurity

1. 1Drug Ineffective10,08610%
2. 2Product Use Issue9,93510%
3. 3Off Label Use9,1289.3%
4. 4Diarrhoea7,2817.4%
5. 5Nausea6,0956.2%
6. 6Constipation5,3855.5%
7. 7Fatigue4,8855.0%
8. 8Vomiting4,2284.3%
9. 9Product Use In Unapproved Indication3,6933.7%
10. 10Pain3,1823.2%
11. 11Headache2,9893.0%
12. 12Dyspnoea2,9623.0%
13. 13Death2,8622.9%
14. 14Asthenia2,8552.9%
15. 15Incorrect Drug Administration Duration2,8402.9%

The 10 most recently updated of 153 ClinicalTrials.gov registrations naming Polyethylene Glycol 3350 as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Effect of Miralax NPO Time on Residual Gastric Volumes and Bowel Preparation
  Not yet recruiting · Interventional · 200 enrolled · Stanford University
  NCT07616908updated 2026-06-01
• Assessment of Safety, Quality, and Acceptance of a Bowel Preparation Using a Food Kit With Laxatives
  Completed · Phase 4 · Interventional · 57 enrolled · Joseph Spataro
  NCT07605897updated 2026-05-26
• Senna vs. Polyethylene Glycol 3350 for the Treatment of Retentive Encopresis in Children: a Randomized, Double-blinded, Study
  Not yet recruiting · Early phase 1 · Interventional · 80 enrolled · Shaare Zedek Medical Center
  NCT07604025updated 2026-05-22
• Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing
  Completed · Phase 4 · Interventional · 1,180 enrolled · Parc de Salut Mar
  NCT04598880updated 2026-05-14
• Ultra-hypofractionated Radiation in Prostate Cancer
  Completed · Interventional · 13 enrolled · University of Kansas Medical Center
  NCT03486821updated 2026-05-05
• Comparison of Potassium Binders in the ER
  Terminated · Phase 4 · Interventional · 37 enrolled · University of California, Irvine
  NCT04585542updated 2026-04-22
• Study Assessing CLENPIQ as Bowel Preparation for Pediatric Colonoscopy
  Recruiting · Phase 1 · Phase 2 · Interventional · 30 enrolled · Ferring Pharmaceuticals
  NCT04113382updated 2026-04-09
• Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery
  Completed · Phase 4 · Interventional · 74 enrolled · University Hospitals Cleveland Medical Center
  NCT06159777updated 2026-03-25
• Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants
  Active not recruiting · Phase 3 · Interventional · 631 enrolled · ViiV Healthcare
  NCT02938520updated 2026-03-19
• Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 Mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study
  Recruiting · Phase 2 · Interventional · 30 enrolled · Sunnybrook Health Sciences Centre
  NCT06016387updated 2026-02-23

Frequently asked questions

How does Polyethylene Glycol 3350 work?

Mechanism-of-action classes: Osmotic Activity; Unknown Cellular or Molecular Interaction.

What is Polyethylene Glycol 3350 used for?

According to FDA labeling, Polyethylene Glycol 3350 carries indications including: Use • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Polyethylene Glycol 3350?

Polyethylene Glycol 3350 is classified as Osmotic Laxative, Osmotic Activity, Unknown Cellular or Molecular Interaction, Inhibition Large Intestine Fluid/Electrolyte Absorption, Stimulation Large Intestine Fluid/Electrolyte Secretion.

What are the brand names for Polyethylene Glycol 3350?

Polyethylene Glycol 3350 is marketed under brand names including ClearLax, Comfortlax, Dulcolax Osmotic, GaviLyte-C, GaviLyte-N, Gavilax, Gavilyte-G, Gavilyte-H.