Polyethylene Glycol 3350 17 g/17g
InstaLax Polyethylene Glycol 3350 · POWDER, FOR SOLUTION · Sun Pharmaceutical Industries, Inc.
Polyethylene Glycol 3350 is a powder, for solution containing instalax polyethylene glycol 3350 at 17 g/17g, taken oral. Manufactured by Sun Pharmaceutical Industries, Inc..
Key Facts
- Brand Name
- Polyethylene Glycol 3350
- Generic Name
- InstaLax Polyethylene Glycol 3350
- NDC Code (Product)
51672-2104- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Strength
- 17 g/17g
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA203928
- Drug Class
- Osmotic Laxative [EPC]
- Marketing Start
- 10/09/2025
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
LUPIN SOMERSET
Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.
Geritrex Corp
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Kroger Specialty Pharmacy, Inc.
Lack of Processing Controls.
Lupin Pharmaceuticals Inc.
Failed Stability Specification
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
USE • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days
Dosage & Administration
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 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 difficult 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
WARNINGS Allergy alert: Do not use if you are allergic to polyethylene glycol
Frequently Asked Questions
What is Polyethylene Glycol 3350 used for?
Polyethylene Glycol 3350 contains InstaLax Polyethylene Glycol 3350. It is a powder, for solution taken oral. Consult your doctor for specific uses.
Is Polyethylene Glycol 3350 a controlled substance?
Polyethylene Glycol 3350 is not classified as a controlled substance by the DEA.
What is the generic name for Polyethylene Glycol 3350?
The generic name for Polyethylene Glycol 3350 is InstaLax Polyethylene Glycol 3350. There are no other listed brand versions of InstaLax Polyethylene Glycol 3350.
What is the NDC code for Polyethylene Glycol 3350 17 g/17g?
The NDC (National Drug Code) for Polyethylene Glycol 3350 17 g/17g is 51672-2104, listed by Sun Pharmaceutical Industries, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)