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 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:

• 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, USPis 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 bisacodyldelayed-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 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:

• 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 bisacodyldelayed-release tablet, USP?

Before you take GaviLyte - H and bisacodyldelayed-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 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:

• medicines for blood pressure or heart problems
• medicines for kidney problems
• medicines for depression
• water pills (diuretics)
• non-steroidal anti-inflammatory medicines (NSAID) pain medicines
• laxatives
• antacids

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.

• Take GaviLyte - H and bisacodyl delayed-release tablet, USP exactly as your healthcare provider tells you to take it.
• Do not take other laxatives while taking GaviLyte - H and bisacodyl delayed-release tablet, USP.
• Do not take antacids within 1 hour of taking the bisacodyl tablet.
• Do not chew or crush the bisacodyl tablet. Take the tablet with water.
• Do not eat solid foods while taking GaviLyte - H and bisacodyl delayed-release tablet, USP. Only clear liquids are allowed while taking and after taking GaviLyte - H and bisacodyl delayed-release tablet, USP until your colonoscopy.
• Stop drinking GaviLyte - H temporarily or allow for longer time between each dose if you have stomach discomfort, pain or bloating until your symptoms improve.
• Stop taking GaviLyte - H and bisacodyl delayed-release tablet, USP and call your healthcare provider right away if you develop hives or a rash. These may be signs of an allergic reaction.

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:

• See “What is the most important information I should know about GaviLyte - H and bisacodyl delayed-release tablet, USP?”
• changes in certain blood tests. Your healthcare provider may do blood tests after you take GaviLyte - H and bisacodyl delayed-release tablet, USP to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including:
• vomiting
• nausea
• bloating
• dizziness
• stomach (abdominal) cramping
• headache
• urinate less than usual
• trouble drinking clear liquid
• heart problems. GaviLyte - H and bisacodyldelayed-release tablet, USP may cause irregular heartbeats.
• seizures
• decreased blood flow to the intestine (ischemic colitis). There have been reports of ischemic colitis in people who have taken GaviLyte - H and bisacodyl delayed-release tablet, USP at higher doses. Tell your healthcare provider right away if you have severe stomach (abdominal) pain or rectal bleeding. These may be symptoms of ischemic colitis.

  The most common side effects of GaviLyte - H and bisacodyl delayed-release tablet, USP include:

• discomfort
• bloating
• stomach (abdominal) cramping
• nausea
• vomiting

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?

• 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 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