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) 3...
GaviLyte - H and bisacodyl delayed-release tablet, USP is indicated for cleansing of the colon as a preparation for colonoscopy in adults.
The recommended GaviLyte - H and bisacodyl delayed-release tablet, USP oral dosage regimen for adults on the day prior to colonoscopy is as follows:
The GaviLyte - H and bisacodyl delayed-release tablet, USP is contraindicated in the following conditions:
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)]
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.
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.
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.
There have been reports of ischemic colitis in patients with use of GaviLyte - H and 20 mg bisacodyl delayed-release tablet, USP and GaviLyte - H and 10 mg bisacodyl delayed-release tablet, USP. If patients develop severe abdominal pain or rectal bleeding, patients should be evaluated as soon as possible.
If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering GaviLyte - H and bisacodyl delayed-release tablet, USP
Use with caution in patients with severe active ulcerative colitis.
Use with caution in patients with impaired gag reflex and patients prone to regurgitation or aspiration. Such patients should be observed during administration of the GaviLyte - H and bisacodyl delayed-release tablet, USP solution.
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.
| 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% |
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)]
.
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.
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.
Do not take the bisacodyl delayed-release tablet within one hour of taking an antacid.
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.
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.
Safety and effectiveness in pediatric patients has not been established.
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)]
.
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)] .
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.
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.
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.
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.
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of GaviLyte - H and bisacodyl delayed-release tablet, USP. Studies to evaluate its potential for impairment of fertility or its mutagenic potential have not been performed.
The colon cleansing efficacy of GaviLyte - H and bisacodyl delayed-release tablet, USP (with 5 mg of bisacodyl) was evaluated in a randomized, single blind (endoscopist only), active-controlled, multicenter study. In this study, 293 adult patients were included in the efficacy analysis. Patients ranged in age from 19 to 87 years old (mean age 55 years old) with 55% female and 45% male patients. Race was distributed as follows: 83% White, 12% African American, 8% Hispanic or Latino, and 4% other.
Patients were randomized to one of the following two colon preparations: 1) GaviLyte - H and bisacodyl delayed-release tablet, USP [10 mg of bisacodyl tablets were given at noon on the day before colonoscopy followed by 2 liters of GaviLyte - H (after the first bowel movement or maximum of 6 hours)] at a rate of 8 ounces every 10 minutes and 2) a modified GaviLyte - H and bisacodyl delayed-release tablet, USP [containing a 5 mg bisacodyl tablet given at noon on the day before colonoscopy followed by 2 liters of GaviLyte - H (after the first bowel movement or maximum of 6 hours)] at a rate of 8 ounces every 10 minutes.
Patients were instructed to refrain from solid food and to have clear liquids on the day before colonoscopy. In addition, patients were instructed to consume nothing by mouth, except clear liquids, from the time the preparation was completed until after the colonoscopy was completed.
The primary efficacy endpoint was the proportion of patients with successful colon cleansing (assessed by the colonoscopists), see Table 2 below. Successful colon cleansing was defined as preparations that were graded excellent (no more than small bits of adherent feces/fluid) or good (small amounts of feces or fluid not interfering with the exam) by the colonoscopist.
| GaviLyte - H and 5 mg Bisacodyl Delayed-release Tablet, USP (H5) | GaviLyte - H and 10 mg Bisacodyl Delayed-release Tablet, USP (H10) | Difference between treatment groups(H5 - H10) | ||||
| % (n/N) | Two-sided 95% CI 1 | % (n/N) | Two-sided 95% CI 1 | Percent Difference % | Two-sided 95% CI for Percent Difference | |
| 1Confidence Interval (CI) for within treatment percent success is from an exact Chi Square test. | ||||||
| All Patients | 78 (114/147) | (69.9, 84.0) | 80 (117/146) | (72.7, 86.3) | -2.0 | (-11.9, 6.8) |
The proportion of patients with successful colon cleansing was similar between treatment groups. No differences in response rates by gender or race were noted in the GaviLyte - H and 5 mg bisacodyl group. In patients ≥ 65 years of age treated with the GaviLyte - H and 5 mg bisacodyl delayed-release tablet, USP the proportion with successful colon cleansing was 67% (n=28/42)[ 95% CI: ( 50.5, 80.4)].
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.
See Medication Guide
Information for Patients
Manufactured by:
Novel Laboratories, Inc.
Somerset, NJ 08873
Manufactured for:
GAVIS Pharmaceuticals, LLC
Somerset, NJ 08873
PI0701700201
Iss. 12/2014
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 bisacodyldelayed-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:
Your chance of having fluid loss and changes in body salts with GaviLyte - H and bisacodyl delayed-release tablet, USPis higher if you:
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 bisacodyldelayed-release tablet, USP:
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 bisacodyldelayed-release tablet, USP?
Do not take GaviLyte - H and bisacodyl delayed-release tablet, USP if your healthcare provider has told you that you have:
What should I tell my healthcare provider before taking GaviLyte - H and bisacodyldelayed-release tablet, USP?
Before you take GaviLyte - H and bisacodyldelayed-release tablet, USP tell your healthcare provider if you:
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 by mouth may not be absorbed properly when taken within 1 hour before the start of GaviLyte - H and bisacodyl delayed-release tablet, USP.
Especially tell your healthcare provider if you take:
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take GaviLyte - H and bisacodyldelayed-release tablet, USP?
See the Patient Directions on the outer product carton for dosing instructions. You must read, understand, and follow these instructions to take GaviLyte - H and bisacodyldelayed-release tablet, USPthe right way.
What are the possible side effects of GaviLyte - H and bisacodyldelayed-release tablet, USP?
GaviLyte - H and bisacodyl delayed-release tablet, USP can cause serious side effects, including:
The most common side effects of GaviLyte - H and bisacodyl delayed-release tablet, USP include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of GaviLyte - H and bisacodyl delayed-release tablet, USP. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store GaviLyte - H and bisacodyldelayed-release tablet, USP?
Keep GaviLyte - H and bisacodyldelayed-release tablet, USP and all medicines out of the reach of children.
General information about the safe and effective use of GaviLyte - H and bisacodyldelayed-release tablet, USP.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use GaviLyte - H and bisacodyl delayed-release tablet, USP for a condition for which it was not prescribed. Do not give GaviLyte - H and bisacodyl delayed-release tablet, USP to other people, even if they are going to have the same procedure you are. It may harm them.
This Medication Guide summarizes the most important information about GaviLyte - H and bisacodyl delayed-release tablet, USP. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.
What are the ingredients in GaviLyte - H and bisacodyldelayed-release tablet, USP?
Active ingredients bisacodyl tablet: bisacodyl.
Inactive ingredients bisacodyl tablet: 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.
Active ingredients GaviLyte - H: polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride.
Inactive ingredients GaviLyte - H: cherry, lemon, and orange flavor packs.
Manufactured by:
Novel Laboratories, Inc.
Somerset, NJ 08873
Manufactured for:
GAVIS Pharmaceuticals LLC
Somerset, NJ 08873
This Medication Guide has been approved by the U.S. Food and Drug Administration.
PI0701700201
Iss. 12/2014
Carton
With Flavor Packs
Rx Only
New Dose
GaviLyte - H and bisacodyl delayed-release tablet, USP
Front Panel
Back Panel
Side Panel
2 Liter Bottle Label
GaviLyte - H and bisacodyl delayed-release tablet, USP
Blister
GaviLyte - H and bisacodyl delayed-release tablet, USP
Front
Back
Cherry - Flavor Pack
GaviLyte - H and bisacodyl delayed-release tablet, USP
Lemon - Flavor Pack
GaviLyte - H and bisacodyl delayed-release tablet, USP
Orange - Flavor Pack
GaviLyte - H and bisacodyl delayed-release tablet, USP
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1718991 | {1 (bisacodyl 5 MG Delayed Release Oral Tablet) / 1 (2000 ML) (polyethylene glycol 3350 210000 MG / potassium chloride 740 MG / sodium bicarbonate 2860 MG / sodium chloride 5600 MG Powder for Oral Solution [Gavilyte-H]) } Pack [Gavilyte-H and Bisacodyl] | BPCK | 3 |
| 1000479 | {1 (bisacodyl 5 MG Delayed Release Oral Tablet) / 1 (2000 ML) (polyethylene glycol 3350 210000 MG / potassium chloride 740 MG / sodium bicarbonate 2860 MG / sodium chloride 5600 MG Powder for Oral Solution) } Pack | GPCK | 3 |
| 1000479 | 1 (PEG-3350 210 GM / potassium chloride 0.74 GM / sodium bicarbonate 2.86 GM / sodium chloride 5.6 GM Powder for Oral Solution) / 1 (bisacodyl 5 MG Delayed Release Oral Tablet) Pack | PSN | 3 |
| 308753 | bisacodyl 5 MG Delayed Release Oral Tablet | PSN | 3 |
| 1718991 | GaviLyte-H and Bisacodyl Bowel Prep Pack | PSN | 3 |
| 1718990 | Gavilyte-H Powder for Oral Solution | PSN | 3 |
| 1718983 | polyethylene glycol-3350 210 GM / potassium chloride 0.74 GM / sodium bicarbonate 2.86 GM / sodium chloride 5.6 GM Powder for Oral Solution | PSN | 3 |
| 1718990 | polyethylene glycol 3350 210000 MG / potassium chloride 740 MG / sodium bicarbonate 2860 MG / sodium chloride 5600 MG Powder for Oral Solution [Gavilyte-H] | SBD | 3 |
| 308753 | bisacodyl 5 MG Delayed Release Oral Tablet | SCD | 3 |
| 1718983 | polyethylene glycol 3350 210000 MG / potassium chloride 740 MG / sodium bicarbonate 2860 MG / sodium chloride 5600 MG Powder for Oral Solution | SCD | 3 |
| 308753 | bisacodyl 5 MG Enteric Coated Oral Tablet | SY | 3 |
| 1718991 | Gavilyte-H and Bisacodyl Bowel Prep (PEG-3350 210 GM / sodium chloride 5.6 GM / sodium bicarbonate 2.86 GM / potassium chloride 0.74 GM) Powder for 2 L Oral Solution / 1 x bisacodyl Delayed Release Oral Tablet | SY | 3 |
| 1718990 | Gavilyte-H Powder for Oral Solution | SY | 3 |
| 1000479 | PEG-3350 210 GM / potassium chloride 0.740 GM / sodium bicarbonate 2.86 GM / sodium chloride 5.6 GM Powder for 2 L Oral Solution / 1 x bisacodyl 5 MG Delayed Release Oral Tablet | SY | 3 |
| 1718983 | PEG-3350 210 GM / potassium chloride 0.740 GM / sodium bicarbonate 2.86 GM / sodium chloride 5.6 GM Powder for Oral Solution | SY | 3 |
| 1718983 | POLYETHYLENE GLYCOL 3350 210000 MG / K+ Chloride 740 MG / NaHCO3 2860 MG / NaCl 5600 MG Powder for Oral Solution | SY | 3 |
| 1718990 | POLYETHYLENE GLYCOL 3350 210000 MG / K+ Chloride 740 MG / NaHCO3 2860 MG / NaCl 5600 MG Powder for Oral Solution [Gavilyte-H] | SY | 3 |
| 1718983 | POLYETHYLENE GLYCOL 3350 210000 MG / Pot Chloride 740 MG / NaHCO3 2860 MG / NaCl 5600 MG Powder for Oral Solution | SY | 3 |
| 1718990 | POLYETHYLENE GLYCOL 3350 210000 MG / Pot Chloride 740 MG / NaHCO3 2860 MG / NaCl 5600 MG Powder for Oral Solution [Gavilyte-H] | SY | 3 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEACETYLBISACODYL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20181113 |
| POLYETHYLENE GLYCOL 3350 Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| POTASSIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| SODIUM CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43386-010-61 | GaviLyte-H and Bisacodyl | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | 5 mg | 3 |
| 43386-070-17 | GaviLyte-H and Bisacodyl | 2 L in 1 BOTTLE | POWDER, FOR SOLUTION | 2 L | 5.6 g in 2L | 3 |
| 43386-071-83 | GaviLyte-H and Bisacodyl | 1 in 1 KIT | KIT | 1 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43386-010 | GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [LUPIN PHARMACEUTICALS, INC.] | 3 | Unmatched | 20250130_78fe1c29-e22a-4615-a2f9-a61cd4eb38a3.zip |
| 43386-070 | GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [LUPIN PHARMACEUTICALS, INC.] | 3 | Unmatched | 20250130_78fe1c29-e22a-4615-a2f9-a61cd4eb38a3.zip |
| 43386-071 | GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [LUPIN PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 3 package rows | 20250130_78fe1c29-e22a-4615-a2f9-a61cd4eb38a3.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43386-071-83 | EA - Each | 43386-071 | 0f99747e-b7ec-47a3-882c-c01de181f8b8 | 1 | 2015-06-09 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BISACODYL | ACTIVE INGREDIENT | 10X0709Y6I | 1 | |
| POLYETHYLENE GLYCOL 3350 | ACTIVE INGREDIENT | G2M7P15E5P | 1 | |
| POTASSIUM CHLORIDE | ACTIVE INGREDIENT | 660YQ98I10 | 1 | |
| SODIUM BICARBONATE | ACTIVE INGREDIENT | 8MDF5V39QO | 1 | |
| SODIUM CHLORIDE | ACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| BISACODYL | ACTIVE MOIETY | 10X0709Y6I | 1 | |
| CHLORIDE ION | ACTIVE MOIETY | Q32ZN48698 | 1 | |
| POLYETHYLENE GLYCOL 3350 | ACTIVE MOIETY | G2M7P15E5P | 1 | |
| POTASSIUM CATION | ACTIVE MOIETY | 295O53K152 | 1 | |
| SODIUM CATION | ACTIVE MOIETY | LYR4M0NH37 | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CHERRY | INACTIVE INGREDIENT | BUC5I9595W | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| LEMON | INACTIVE INGREDIENT | 24RS0A988O | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| METHACRYLIC ACID | INACTIVE INGREDIENT | 1CS02G8656 | 1 | |
| ORANGE | INACTIVE INGREDIENT | 5EVU04N5QU | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 43386-071 | 43386-071-83 |
| 43386-010 | 43386-010-61 |
| 43386-070 | 43386-070-17 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, ORALLY DISINTEGRATING / ORAL | 184 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | GRANULE, FOR SUSPENSION / ORAL | 3025 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 3 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | SUSPENSION, EXTENDED RELEASE / ORAL | 5 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, COATED PELLETS / ORAL | 198 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 316 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, FILM COATED / ORAL | 3 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 127 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, EXTENDED RELEASE / ORAL | 4.59 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, FILM COATED / ORAL | 2 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | DROPS / ORAL | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, DELAYED RELEASE / ORAL | 46 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, FILM COATED / ORAL | 240 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE / ORAL | 150 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, COATED / ORAL | 10.6 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 60 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 18 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| CHERRY | CHERRY | BUC5I9595W | TABLET, CHEWABLE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, COATED / ORAL | 24.12 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, COATED / ORAL | 320.75 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, EXTENDED RELEASE / ORAL | 129 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PELLET / ORAL | 2 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, COATED / ORAL | 560 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION / ORAL | 11 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A202217-001 | PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | FOR SOLUTION, TABLET, DELAYED RELEASE / ORAL | 2014-08-20 | f41ea6bd6efb… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| GaviLyte-H and Bisacodyl | POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET | Lupin Pharmaceuticals, Inc. | 78fe1c29-e22a-4615-a2f9-a61cd4eb38a3 | 2025-01-28 | Warnings, Adverse reactions | 43386-010-61 43386-071-83 43386-070-17 43386-071 43386001061 43386007183 43386007017 c34cfe17-96c2-4f07-8a2d-74bc84e61fb4 78fe1c29-e22a-4615-a2f9-a61cd4eb38a3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.
