Quick answers
- What is Polyethylene glycol 3350 and electrolytes - unflavored used for?
- The FDA-approved label (Polyethylene Glycol 3350 and electrolytes - Unflavored, Strides Pharma Science Limited, September 5, 2025) says: “Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. Polyethylene Glycol 3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Polyethylene glycol 3350 and electrolytes - unflavored have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Polyethylene glycol 3350 and electrolytes - unflavored?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Polyethylene glycol 3350 and electrolytes - unflavored been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Polyethylene glycol 3350 and electrolytes - unflavored?
- 1 company lists prescription products of Polyethylene glycol 3350 and electrolytes - unflavored in the FDA NDC Directory, including Strides Pharma Science Limited.
What Polyethylene glycol 3350 and electrolytes - unflavored is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Polyethylene Glycol 3350 and electrolytes for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. Polyethylene Glycol 3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults
— FDA label: Polyethylene Glycol 3350 and electrolytes - Unflavored, Strides Pharma Science Limited, effective September 5, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Powder, for solution |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Strides Pharma Science Limited1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA204558Strides Pharma · December 21, 2018
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 966920 |
|---|---|
| SPL set ID of the quoted label | 48c741a9-9039-4fdb-a875-86d4ea968282 |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | POLYETHYLENE GLYCOL 3350 / POTASSIUM CHLORATE / SODIUM BICARBONATE / SODIUM CHLORIDE / SODIUM SULFATE ANHYDROUS |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Polyethylene Glycol 3350 and electrolytes - Unflavored, Strides Pharma Science Limited, effective September 5, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →