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GaviLyte-H and Bisacodyl Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride and Bisacodyl Delayed-release Tablet Kit

by Lupin Pharmaceuticals, Inc. · 1 KIT in 1 KIT (43386-071-83) * 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (43386-010-61) * 2 L in 1 BOTTLE (43386-070-17)
NDC 43386-0071-83
🏷️ FDA NDC (as labeled) 43386-071-83 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 43386-071-83
Product NDC 43386-071
11-digit billing NDC 43386007183
NCPDP billing unit EA — each (per item)
RxCUI 308753, 1000479, 1718983, 1718990, 1718991
UPC 0343386205028
Application # ANDA202217
SPL Set ID 78fe1c29-e22a-4615-a2f9-a61cd4eb38a3
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-04-21
Route ORAL
Dosage form KIT
GPI-14 46992005206420
GPI class GaviLyte-H
GCN Seq No 066551
GCN 28866
HICL code 033281
Ingredient (HICL) Bisac/Nacl/Nahco3/Kcl/Peg 3350
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6S
Therapeutic class — specific (HIC3) Laxatives And Cathartics
AHFS code 56:12.00.00
AHFS class Cathartics And Laxatives
FDB label name GAVILYTE-H AND BISACODYL KIT
FDB brand name Gavilyte-H And Bisacodyl
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 43386-071-83 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 43386-0071-83. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Stimulant Laxative class.

Pharmacologic class Stimulant Laxative
Drug family (ATC) Contact laxatives, Enemas
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerLupin Pharmaceuticals, Inc.
Application holderNOVEL LABORATORIES INC
FDA applicationANDA202217 (ANDA)
Labeler code43386
First marketedApr 2015
Product typeHuman Prescription Drug
Portfolio404 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name GAVILYTE-H AND BISACODYL KIT Ingredient Bisac/Nacl/Nahco3/Kcl/Peg 3350

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
GaviLyte-H and Bisacodylthis 43386-0071-83 Lupin 1 tablet — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2015
On the market since
Apr 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
43386-0071-83 You're viewing this 1 KIT in 1 KIT (43386-071-83) * 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (43386-010-61) * 2 L in 1 BOTTLE (43386-070-17) 2015-04-21 Active

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 43386-071-83, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 43386-0071-83, written without dashes as 43386007183. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 43386-0071-83, the first segment (43386) is the labeler code FDA assigned to Lupin Pharmaceuticals, Inc.; the middle segment (0071) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (83) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Lupin Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Lupin Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 63 words ▾

1 INDICATIONS & 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 ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE & ADMINISTRATION The recommended GaviLyte - H and bisacodyl delayed-release tablet, USP oral dosage regimen for adults on the day prior to colonoscopy is as follows: No solid food or milk (clear liquids only) should be consumed on the day of the preparation. Take one 5 mg bisacodyl delayed-release tablet, USP with water. Do NOT chew or crush the tablet.

No antacids should be taken within one hour of taking the bisacodyl delayed-release tablet, USP. Prepare the GaviLyte - H solution according to the instructions on the kit. Add flavor pack of choice (if applicable) to the 2 liter container.

No additional ingredients (other than flavor packs provided) should be added to the solution. Prepare the GaviLyte - H solution by filling the container to the 2 liter mark with water. Cap the container.

Shake to dissolve the powder. Wait for a bowel movement (or maximum of 6 hours) then drink the 2 liter GaviLyte - H solution at a rate of 8 ounces every 10 minutes. Drink all of the solution.

If you have abdominal distention or discomfort, stop drinking the GaviLyte - H solution temporarily or drink each portion at longer intervals until your symptoms improve. Consume only clear liquids after taking the GaviLyte - H solution until your colonoscopy. See FULL PRESCRIBING INFORMATION for complete dosing and administration instructions ( 2 ) No solid food or milk (clear liquids only) should be consumed on the day of the preparation.

Take one 5 mg bisacodyl tablet with water. Do NOT chew or crush. Dissolve the GaviLyte - H powder in 2 liters of water.

Wait for a bowel movement (or maximum of 6 hours) then drink all the GaviLyte - H solution at a rate of 8 ounces every 10 minutes. Consume only clear liquids until the colonoscopy.

💊 Dosage Forms and Strengths 63 words ▾

3 DOSAGE FORMS & STRENGTHS One pink, round, enteric coated 5 mg bisacodyl delayed-release tablet, USP, de-bossed with “N1” on one side and plain on the other side. One 2 liter GaviLyte - H bottle with powder for reconstitution One 5 mg bisacodyl delayed-release tablet, USP ( 3 ) One 2 liter GaviLyte - H bottle with powder for reconstitution ( 3 )

⛔ Contraindications 58 words ▾

4 CONTRAINDICATIONS The GaviLyte - H and bisacodyl delayed-release tablet, USP is contraindicated in the following conditions: Gastrointestinal (GI) obstruction Bowel perforation Toxic colitis and toxic megacolon Gastric retention Ileus Gastrointestinal (GI) obstruction ( 4 ) Bowel perforation ( 4 ) Toxic colitis or toxic megacolon ( 4 ) Gastric retention ( 4 ) Ileus ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment – assess concurrent medications and consider testing in some patients ( 5.1 , 5.2 , 5.3 , 5.4 ) Patients with renal impairment – use caution, ensure adequate hydration and consider testing ( 5.3 ) Ischemic colitis has been reported ( 5.5 ) Suspected GI obstruction or perforation – rule out the diagnosis before administration ( 5.6 ) Patients at risk for aspiration – observe during administration ( 5.7 )

5.1Serious Fluid and Serum Chemistry Abnormalities Advise all patients to hydrate adequately before, during, and after the use of GaviLyte - H and bisacodyl delayed-release tablet, USP. If a patient develops significant vomiting or signs of dehydration after taking GaviLyte - H and bisacodyl delayed-release tablet, USP, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment.

Patients with electrolyte abnormalities should have them corrected before treatment with GaviLyte - H and bisacodyl delayed-release tablet, USP. In addition, use caution when prescribing GaviLyte - H and bisacodyl delayed-release tablet, USP for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.[See Drug Interactions ( 7.1 )]

5.2Seizures There have been reports of generalized tonic-clonic seizures with the use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.

Use caution when prescribing the GaviLyte - H and bisacodyl delayed-release tablet, USP for patients with a history of seizures and in patients at risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, patients with known or suspected hyponatremia, or patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities. Monitor baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients.

5.3Renal Impairment Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes (sodium, potassium, calcium, BUN and creatinine). Use caution when prescribing GaviLyte - H and bisacodyl delayed-release tablet, USP for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs).

Advise these patients of the importance of adequate hydration and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.

5.4Cardiac Arrhythmias There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing GaviLyte - H and bisacodyl delayed-release tablet, USP for patients at increased risk of arrhythmias (e.g. patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias.

5.5Ischemic Colitis There have been reports of ischemic colitis in patients with use of GaviL…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (>3%) are overall discomfort, abdominal fullness, abdominal cramping, nausea, and vomiting, ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novel Laboratories, Inc. at 908-603-6000 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. In a clinical study of GaviLyte - H and (5 mg vs. 10 mg) bisacodyl delayed-release tablet, USP, overall discomfort, abdominal fullness, abdominal cramping, nausea, and vomiting, were the most common adverse reactions (>3%).

The data in Table 1 reflects the 154 patients that received GaviLyte - H and 5 mg bisacodyl tablet vs. the 154 patients that received GaviLyte - H and 10 mg bisacodyl tablets. The GaviLyte - H and 5 mg bisacodyl delayed-release tablet, USP population was 29-87 years of age, 49% male, 51% female, 13% African American, 83% White, 5% Hispanic requiring a colonoscopy. The demographics of the comparator group were similar.

Table 1: Adverse Reactions Observed in at Least 3% of Randomized Patients GaviLyte - H and 5 mg Bisacodyl Delayed-release Tablet, USP(N=154)] GaviLyte - H and 10 mg Bisacodyl Delayed-release Tablet, USP(N=154) Overall Discomfort 57% 66% Abdominal fullness 40% 53% Abdominal cramping 38% 46% Nausea 34% 42% Vomiting 10% 7%

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of GaviLyte - H and bisacodyl delayed-release tablet, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Allergic Reactions: Cases of urticaria, rhinorrhea, dermatitis and anaphylactic reactions have been reported with PEG-based products.

Gastrointestinal: There are isolated reports of serious post-marketing events following the administration of PEG-based products in patients over 60 years of age. These adverse reactions include upper GI bleeding from a Mallory-Weiss tear, esophageal perforation, asystole, and acute pulmonary edema after vomiting and aspirating the PEG-based solution. In addition, during administration of 4 liters of PEG-3350 colon cleansing preparation the following serious adverse reactions were seen: two deaths in end stage renal failure patients who developed diarrhea, vomiting and dysnatremia [ see Warnings and Precautions ( 5.3 ) ].

Ischemic colitis has been reported with use of of GaviLyte - H and 20 mg and 10 mg bisacodyl delayed-release tablets, USP for colon preparation prior to colonoscopy. However, a causal relationship between these ischemic colitis cases and the use of GaviLyte - H and bisacodyl delayed-release tablets, USP has not been established. Neurologic: There have been reports of generalized tonic-clonic seizures associated with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures.

Cases of dizziness and syncope have been reported [see Warnings and Precautions ( 5.1 )] .

🔄 Drug Interactions 203 words ▾

7 DRUG INTERACTIONS Some drugs (e.g., diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs) increase risk due to fluid and electrolyte changes ( 7.1 ) Oral medication administered within one hour of the start of drinking GaviLyte - H might not be absorbed fully. ( 7.2 ) Do not take the bisacodyl tablet within one hour of taking antacid ( 7.3 )

7.1Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities Use caution when prescribing GaviLyte - H and bisacodyl delayed-release tablet, USP for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate [see Warnings and Precautions ( 5.1 )] in patients taking these concomitant medications.

7.2Potential for Altered Drug Absorption Oral medication administered within one hour of the start of administration of GaviLyte - H solution may be flushed from the GI tract and the medication may not be absorbed completely.

7.3Interaction with Antacids Do not take the bisacodyl delayed-release tablet within one hour of taking an antacid.

👥 Use in Specific Populations 183 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category C animal reproduction studies have not been conducted. It is not known whether GaviLyte - H and bisacodyl delayed-release tablet, USP can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GaviLyte - H and bisacodyl delayed-release tablet, USP should be given to a pregnant or nursing woman only if clearly needed.

8.3Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GaviLyte - H and bisacodyl delayed-release tablet, USP is administered to a nursing woman.

8.4Pediatric Use Safety and effectiveness in pediatric patients has not been established.

8.5Geriatric Use Of the 148 patients who took GaviLyte - H and 5 mg bisacodyl delayed-release tablet, USP in clinical trials, 42 (28%) were 65 years of age or older, while 10 (7%) were 75 years of age or older. The rates of success appear to be lower in patients 65 years and older [see Clinical Studies ( 14 )] .

🆘 Overdosage 40 words ▾

10 OVERDOSAGE Using more than the recommended dosage of bisacodyl in conjunction with GaviLyte - H solution increases the frequency of common adverse events and may increase the risk of ischemic colitis [see Warnings and Precautions ( 5.5 )] .

🧬 Clinical Pharmacology 129 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Polyethylene glycol (PEG), which is an osmotic agent, causes water to be retained within the gastrointestinal tract. Bisacodyl is hydrolyzed by intestinal brush border enzymes and colonic bacteria to form an active metabolite [bis-(p-hydroxyphenyl) pyridyl-2 methane; (BHPM)] that acts directly on the colonic mucosa to produce colonic peristalsis.

12.2Pharmacodynamics The stimulant laxative effect of bisacodyl, together with the osmotic effect of the unabsorbed PEG when ingested with a large volume of water, produces watery diarrhea.

12.3PharmacoKinetics When taken orally, PEG 3350 is minimally absorbed. Bisacodyl, which is a prodrug, is converted to its active metabolite BHPM by intestinal brush border enzymes and colonic bacteria. The pharmacokinetics of bisacodyl following oral administration of the bisacodyl tablet has not been adequately characterized.

📦 How Supplied / Storage and Handling 180 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Each GaviLyte - H and bisacodyl delayed-release tablet, USP contains: One 5 mg bisacodyl delayed-release tablet, USP: pink, round, enteric coated, debossed “N1” on one side and plain on the other in a blister strip. One 2 liter bottle of GaviLyte – H (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution containing 210 grams of polyethylene glycol (PEG) 3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride, and 2 gram of flavoring ingredients (if applicable).

After adding 2 liters of water, the reconstituted GaviLyte - H solution (clear and colorless) contains 31.3 mmol/L of PEG-3350, 65 mmol/L of sodium, 53 mmol/L of chloride, 17 mmol/L of bicarbonate and 5 mmol/L of potassium. GaviLyte - H and bisacodyl delayed-release tablet, USP with Flavor Packs contain 3 packs (2 gram each Cherry, Lemon, and Orange flavors) NDC 43386-071-83. Storage: Store at 20-25°C (68-77°F).

Excursions permitted between 15-30°C (59-86°F). The reconstituted GaviLyte – H solution, which may be refrigerated, should be used within 48 hours.

📋 Description ~1 min read ▾

11 DESCRIPTION GaviLyte - H and bisacodyl delayed-release tablet, USP consists of PEG-3350, an osmotic laxative and bisacodyl, a stimulant laxative. Each GaviLyte - H and 5 mg bisacodyl delayed-release tablet, USP (Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet) consists of one 2 liter bottle of GaviLyte – H (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and one 5 mg bisacodyl, delayed-release tablet, USP.

Bisacodyl delayed-release tablet, USP: Each pink, round, enteric coated bisacodyl delayed-release tablet, USP (debossed “N1”) contains 5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40. Inactive ingredients include lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, methacrylic acid copolymer, talc, titanium dioxide, triethyl citrate, D&C red # 27/phloxine aluminum lake, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, FD&C blue # 2/indigo carmine aluminum lake and FD&C yellow # 6/sunset yellow FCF aluminum lake.

The bisacodyl delayed-release tablet, USP is administered orally prior to drinking the GaviLyte - H [see Dosage and Administration ( 2 )] . GaviLyte – H (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution): A white powder for reconstitution containing 210 grams of PEG-3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride and 2 grams of flavoring ingredients (if applicable). Flavor Packs are available in Cherry (containing artificial cherry flavor powder, maltodextrin and sodium saccharin), Lemon (containing natural lemon flavor powder, maltodextrin and sodium saccharin), and Orange (containing natural and artificial orange flavor powder, maltodextrin and sodium saccharin).

This preparation can be used without the addition of a Flavor Pack. When dissolved in water to a volume of 2 liters, the GaviLyte - H solution is isosmotic, clear, and colorless. The GaviLyte - H solution is administered orally after taking the one bisacodyl delayed-release tablet, USP [see Dosage and Administration ( 2 )] .

💬 Information for Patients 191 words ▾

17 PATIENT COUNSELING INFORMATION See Medication Guide Information for Patients Ask patients to let you know if they have trouble swallowing or are prone to regurgitation or aspiration. Tell patients not to take other laxatives while they are taking GaviLyte - H and bisacodyl delayed-release tablet , USP Tell patients that if they experience severe bloating, distention or abdominal pain, the administration of the solution should be slowed or temporarily discontinued until the symptoms abate. Advise patients to report these events to their health care provider.

Advise patients that if they have hives, rashes, or any allergic reaction, they should discontinue the medication and contact their health care provider. Medication should be discontinued until they speak to their physician. Instruct patients to contact their healthcare provider if they develop signs and symptoms of dehydration. [see Warnings and Precautions (5.1)].

Inform patients that oral medication administered within one hour of the start of administration of GaviLyte - H may be flushed from the GI tract and the medication may not be absorbed completely. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: GAVIS Pharmaceuticals, LLC Somerset, NJ 08873 PI0701700201 Iss.

12/2014

💬 Medication Guide ~3 min read ▾

Medication Guide GaviLyte - H (GAV-ee-LITE-H) and Bisacodyl (BIS-a-CO-dil) Delayed-Release Tablet , USP. (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet, USP) Read this Medication Guide before you start taking GaviLyte - H and bisacodyl delayed-release tablet, USP. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

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.

What is GaviLyte - H and bisacodyl delayed-release tablet, USP? GaviLyte - H and bisacodyl delayed-release tablet, USP is a prescription medicine used by adults to clean the colon before a colonoscopy. GaviLyte - H and bisacodyl delayed-release tablet, USP cleans your colon by causing you to have diarrhea.

Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. It is not known if GaviLyte - H and bisacodyl delayed-release tablet, USP is safe and effective in children. Who should not take GaviLyte - H and bisacodyl delayed-release tablet, USP?

Do not take GaviLyte - H and bisacodyl delayed-release tablet, USP if your healthcare provider has told you that you have: a blockage in your bowel (obstruction) an opening in the wall of your stomach or intestine (bowel perforation) problems with food and fluid emptying from your stomach (gastric retention) a very dilated intestine (bowel) an allergy to any of the ingredients in GaviLyte - H and bisacodyl delayed-release tablet, USP. See the end of this leaflet for a complete list of ingredients in GaviLyte - H and bisacodyl delayed-release tablet, USP.

What should I tell my healthcare provider before taking GaviLyte - H and bisacodyl delayed-release tablet, USP? Before you take GaviLyte - H and bisacodyl delayed-release tablet, USP tell your healthcare provider if you: have heart problems have stomach or bowel problems have ulcerative colitis have problems with swallowing or gastric reflux have a history of seizures are withdrawing from drinking alcohol have a low blood salt (sodium) level have kidney problems have any other medical conditions are pregnant. It is not known if GaviLyte - H and bisacodyl delayed-release tablet, USP will harm your unborn baby.

Talk to your doctor if you are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed. It is not known if GaviLyte - H and bisacodyl delayed-release tablet, USP passes into your breast milk. You and your healthcare provider should decide if you will take GaviLyte - H and bisacodyl delayed-release tablet, USP while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. GaviLyte - H and bisacodyl delayed-release tablet, USP may affect how other medicines work. Medicines taken b…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.