Prescription medicine

Bisacodyl, polyethylene glycol 3350 and 3 other ingredients First approved as Halflytely

Bisacodyl, polyethylene glycol 3350 and 3 other ingredients (Halflytely) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 1 generic labeler.

Generic listed

Check it at the source: the bisacodyl, polyethylene glycol 3350 and 3 other ingredients FDA label on DailyMed (effective January 28, 2025, Lupin Pharmaceuticals, Inc.); the NDA 21551 record on Drugs@FDA; every bisacodyl, polyethylene glycol 3350 and 3 other ingredients label on DailyMed.

Highlights of the record

FDA label of January 28, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
GaviLyte - H and bisacodyl delayed-release tablet, USP is indicated for cleansing of the colon as a preparation for colonoscopy in adults.

Forms and strengths

Kit.

On the market

Earliest approval on file: May 10, 2004 Halflytely, Braintree; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 1 first August 20, 2014; 0 with a marketed status in Drugs@FDA
Labelers listed (NDC): 1 of which 1 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is bisacodyl, polyethylene glycol 3350 and 3 other ingredients used for?

From the label: indications and usage
GaviLyte - H and bisacodyl delayed-release tablet, USP is indicated for cleansing of the colon as a preparation for colonoscopy in adults. GaviLyte - H and bisacodyl delayed-release tablet, USP is a combination of PEG-3350, an osmotic laxative and bisacodyl, a stimulant laxative, indicated for cleansing of the colon as a preparation for colonoscopy in adults

Source: FDA drug label (GaviLyte-H and Bisacodyl), ANDA202217 (Novel Labs Inc), as published by Lupin Pharmaceuticals, Inc., effective January 28, 2025 (SPL set 78fe1c29-e22a-4615-a2f9-a61cd4eb38a3), via openFDA; the full label on DailyMed

What does the patient leaflet for bisacodyl, polyethylene glycol 3350 and 3 other ingredients say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about GaviLyte - H and bisacodyl delayed-release tablet, USP?
GaviLyte - H and bisacodyl delayed-release tablet, USP and other osmotic bowel preparations can cause serious side effects, including: Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause: seizures. This can happen even if you have never had a seizure. kidney problems abnormal heartbeats that can cause death Your chance of having fluid loss and changes in body salts with GaviLyte - H and bisacodyl delayed-release tablet, USP is higher if you: have heart problems have kidney problems take water pills or non-steroidal anti-inflammatory drugs (NSAIDS) Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking GaviLyte - H and bisacodyl delayed-release tablet, USP: dizziness urinating less often than normal headache See “What are the possible side effects of GaviLyte - H and bisacodyl delayed-release tablet, USP?” for more information about side effects.

From the patient leaflet: How should I store GaviLyte - H and bisacodyl delayed-release tablet, USP?
Store GaviLyte - H and bisacodyl delayed-release tablet, USP at 20-25°C (68-77°F)., Excursions permitted between 15-30°C (59-86°F). GaviLyte - H solution that has been mixed with water may be refrigerated. Mixed solution should be taken within 48 hours. Keep GaviLyte - H and bisacodyl delayed-release tablet, USP and all medicines out of the reach of children.

Is there a generic for bisacodyl, polyethylene glycol 3350 and 3 other ingredients (Halflytely)?

The FDA approved the first generic bisacodyl, polyethylene glycol 3350 and 3 other ingredients on August 20, 2014. 1 generic application is approved; 0 of it carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.

FDA's NDC Directory lists bisacodyl, polyethylene glycol 3350 and 3 other ingredients from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

2004 earliest approval on file
2014 first generic approved

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What next?

Check an interaction: what two or more labels say about each other