Polyethylene Glycol 3350 17 g/17g
Polyethylene Glycol 3350 · POWDER, FOR SOLUTION · Strides Pharma Inc
Polyethylene Glycol 3350 is a powder, for solution containing polyethylene glycol 3350 at 17 g/17g, taken oral. Manufactured by Strides Pharma Inc.
Key Facts
- Brand Name
- Polyethylene Glycol 3350
- Generic Name
- Polyethylene Glycol 3350
- NDC Code (Product)
59556-762- Manufacturer
- Strides Pharma Inc
- Strength
- 17 g/17g
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA203928
- Drug Class
- Osmotic Laxative [EPC]
- Marketing Start
- 08/25/2016
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 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 Polyethylene Glycol 3350. There are 9 other brand versions of 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 59556-762, listed by Strides Pharma Inc.