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CLINICAL PHARMACOLOGY TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) induces a diarrhea which rapidly cleanses the bowel, usually within four hours. The osmotic activity of polyethylene glycol 3350 and the electrolyte concentration result in virtually no net absorption or excretion of ions or water. Accordingly, large volumes may be administered without significant changes in fluid or electrolyte balance.

CLINICAL PHARMACOLOGY Mechanism 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. Pharmacodynamics 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. Pharmacokinetics 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. Clinical Studies 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 tablets, 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 of 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. Table 2: Proportion of Patients with Successful Colon Cleansing 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% CI1 % (n/N) Two-sided 95% CI1 Percent Difference % Two-sided 95% CI for Percent Difference All Patients 78 (114/147) (69.9, 84.0) 80 (117/146) (72.7, 86.3) -2.0 (-11.9, 6.8) 1Confidence Interval (CI) for within treatment percent success is from an exact Chi Square test. 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)].

TriLyte® with flavor packs (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride) for Oral Solution When reconstituted with water to a volume of 4 liters, this solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. This package contains the following ingredients: Polyethylene Glycol 3350 420 g Sodium Bicarbonate 5.72 g Sodium Chloride 11.2 g Potassium Chloride 1.48 g Store in sealed container at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). DESCRIPTION TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) ® is a white powder for reconstitution containing 420 g polyethylene glycol 3350, 5.72 g sodium bicarbonate, 11.2 g sodium chloride, 1.48 g potassium chloride. Flavor packs, each containing 3.22 g of flavoring ingredients, are attached to the 4 liter bottle. See individual flavor packs for complete listing of ingredients. When dissolved in water to a volume of 4 liters, TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) ® with flavor packs (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) is an isosmotic solution, for oral administration, having a pleasant mineral water taste. One flavor pack can be added before reconstitution to flavor the solution. TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) is administered orally or via nasogastric tube as a gastrointestinal lavage.

INDICATIONS TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) is indicated for bowel cleansing prior to colonoscopy. DOSAGE AND ADMINISTRATION TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) is usually administered orally, but may be given via nasogastric tube to patients who are unwilling or unable to drink the solution. Ideally, the patient should fast for approximately three or four hours prior to TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) administration, but in no case should solid food be given for at least two hours before the solution is given. Oral Administration: Adults: At a rate of 240 mL (8 oz.) every 10 minutes, until the rectal effluent is clear or 4 liters are consumed. Pediatric Patients (aged 6 months or greater): At a rate of 25 mL/kg/hour, until the rectal effluent is clear or 4 liters are consumed. Rapid drinking of each portion is preferred to drinking small amounts continuously. Nasogastric Tube Administration: Adults: At a rate of 20-30 mL per minute (1.2-1.8 liters per hour). Pediatric Patients (aged 6 months or greater): At a rate of 25 mL/kg/hour, until the rectal effluent is clear or 4 liters are consumed. The first bowel movement should occur approximately one hour after the start of TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) administration. Ingestion of 4 liters of TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) solution prior to gastrointestinal examination produces satisfactory preparation in over 95% of patients. Various regimens have been used. One method is to schedule patients for examination in midmorning or later, allowing the patients three hours for drinking and an additional one hour period for complete bowel evacuation. Another method is to administer TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) on the evening before the examination. Preparation of the Solution: This preparation can be used with or without the flavor packs. The pharmacist should dispense the bottle and the attached flavor packs to the patient. To add flavor, tear open one flavor pack at the indicated marking and pour contents into the bottle BEFORE reconstitution. Discard unused flavor packs. SHAKE WELL to incorporate flavoring into the powder. Add tap water to FILL line marked 4 liters. Replace cap tightly and SHAKE WELL until all ingredients have dissolved. No additional ingredients, e.g., flavorings, should be added to the solution. Note: If not using flavor packs, omit steps one and two above. Dissolution is facilitated by using lukewarm water. The solution is more palatable if chilled before administration. However, chilled solution is not recommended for infants. The reconstituted solution should be refrigerated and used within 48 hours. Discard any unused portion. HOW SUPPLIED TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) is supplied in a 4 liter bottle with an attached package containing flavor packs.This preparation is supplied in powdered form (white to off-white powder) for oral administration as a solution following reconstitution. Each 4 liter bottle contains polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g. Each flavor pack contains 3.22 g flavoring ingredients. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) 4 liter NDC 0091-0447-23 STORAGE: Store in sealed container at 25°C (77°F); excursions permitted between 15° - 30° C (59° - 86°F). When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion. SCHWARZ PHARMA, LLC Milwaukee, WI 53201, USA. TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) ® is a registered trademark of SRZ Properties, Inc. FDA rev date: 2/5/2004

INDICATIONS GaviLyte-H and bisacodyl delayed-release tablet, USP is indicated for cleansing of the colon as a preparation for colonoscopy in adults. DOSAGE AND 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. HOW SUPPLIED Dosage Forms And Strengths One pink, round, enteric coated 5 mg bisacodyl delayed-release tablet, USP, debossed with "N1” on one side and plain on the other side. One 2 literGaviLyte-H bottle with powder for reconstitution 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. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Revised: Dec 2014

PATIENT INFORMATION Instructions for Patient: TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) can be used with or without the addition of one flavor pack. If you prefer an unflavored solution, discard the flavor packs and proceed to step 5. If you prefer a flavored solution, proceed to step 2. Choose one of the flavor packs. Tear open the selected flavor pack at the indicated marking and pour the contents into the bottle BEFORE adding any water. Discard the unused flavor packs. SHAKE WELL to incorporate flavoring into the powder. Add tap water to the top of the FILL line marked 4 liters. Recap tightly and SHAKE WELL until the powder has completely dissolved. No additional ingredients should be added to the solution. For best results, no solid food should be consumed for the 3 to 4 hour period before drinking the solution, but in no case should solid food be eaten within two hours of taking TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) . Adults: Drink one 8 ounce (240 mL) cup of the solution rapidly every 10 minutes. Continue drinking until the watery stool is clear and free of solid matter. This usually requires at least 3 liters. Pediatric Patients (aged 6 months or greater): Drink at a rate of 25 mL/kg/hour. A loose watery bowel movement should result in approximately one hour. Continue drinking until the watery stool is clear and free of solid matter. NOTE: The solution is more palatable if chilled in the refrigerator before drinking. However, chilled solution is not recommended for infants. Keep reconstituted solution refrigerated. Use within 48 hours. Discard unused portion. Patient Product Information What is TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs? TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs is a solution (PEG lavage) that cleanses the bowel in preparation for a colonoscopy. What flavors are available with TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs? TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs features five flavors-Lemon Lime, Orange, Pineapple, Cherry and Citrus Berry. How should I take TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs? TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs should be taken in an eight-ounce glass every 10 minutes and drunk rapidly (not in small sips) according to your physician's instructions. How long does it take to work? TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs begins to work in about an hour. The whole process takes approximately four to six hours. Can children take TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs? Yes, children six months and older can take the solution according to the physician's instructions. What are the side effects of TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs? Nausea, abdominal fullness, and bloating occur in up to 50% of patients. Abdominal cramps, vomiting and anal irritation occur less frequently. Side effects are temporary and subside quickly. As with all polyethylene glycol (PEG) lavages, nausea, abdominal fullness, and bloating are the most common adverse reactions, occurring in up to 50% of patients. Oral medication administered within 1 hour of the start of administration of TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs may be flushed from the gastrointestinal tract and not absorbed. Ask your healthcare professional whether TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs is right for you. For complete prescribing information for TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs, visit www.yourcolonhealth.com or www.trilyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) .com. How do I prepare the solution? The solution can be used with or without flavor packs. The flavor packs are designed to make the solution taste better. Prepare the solution as follows: To add flavor, tear open one flavor pack at the indicated marking and pour contents into the bottle BEFORE adding water. Discard unused flavor packs. SHAKE WELL to incorporate flavoring into the powder. Add LUKEWARM tap water to the top of the FILL line marked 4 liters. Replace cap tightly and SHAKE WELL until all ingredients have dissolved. No additional ingredients, for example, flavorings, should be added to the solution. IMPORTANT NOTES: If you are NOT using a flavor pack, omit steps 1 and 2 above. Lukewarm tap water should be used to prepare the solution. After the solution is mixed, it can be chilled in the refrig- erator to make it more pleasant to drink. It is NOT recommended that a chilled solution be given to infants. The solu- tion should be used within 48 hours of mixing. Discard any unused portions. If you have any questions, talk to your healthcare professional. He or she is always the best source of information and advice. As with all polyethylene glycol (PEG) lavages, nausea, abdominal fullness, and bloating are the most common adverse reactions, occurring in up to 50% of patients. Oral medication administered within 1 hour of the start of administration of TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs may be flushed from the gastrointestinal tract and not absorbed. Ask your healthcare professional whether TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs is right for you. For complete prescribing information for TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs, visit www.yourcolonhealth.com or www.trilyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) .com.

PATIENT INFORMATION 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 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 bisacodyl delayed-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 bisacodyl delayed-release tablet, USP the 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 solution 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 bisacodyl delayed-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 bisacodyl delayed-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 bisacodyl delayed-release tablet, USP? Store GaviLyte-H and bisacodyl delayed-release tablet, USP at 20-25°C (68-77°F); Excursions permitted between 15-30°C (59-86°F). GaviLyte-H solution that has been mixed with water may be refrigerated. Mixed solution should be taken within 48 hours. Keep GaviLyte-H and bisacodyl delayed-release tablet, USP and all medicines out of the reach of children. General information about the safe and effective use of GaviLyte-H and bisacodyl delayed-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 bisacodyl delayed-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 solution: polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride. Inactive ingredients GaviLyte-H solution: cherry, lemon and orange flavor packs.

OVERDOSE No information provided. CONTRAINDICATIONS TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) is contraindicated in patients known to be hypersensitive to any of the components. TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.

SIDE EFFECTS Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) ® with flavor packs. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis, and (rarely) anaphylactic reaction have been reported which may represent allergic reactions. Published literature contains isolated reports of serious adverse reactions following the administration of PEG-ELS products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and "butterfly-like" infiltrate on chest X-ray after vomiting and aspirating PEG. DRUG INTERACTIONS Oral medication administered within one hour of the start of administration of TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) may be flushed from the gastrointestinal tract and not absorbed.

SIDE EFFECTS Clinical 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% Postmarketing 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]. Ischemic colitis has been reported with use of GaviLyte-H and 20 mg and 10 mg bisacodyl delayed-release tablet, 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 tablet, 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]. DRUG INTERACTIONS Drugs 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] in patients taking these concomitant medications. Potential 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. Interaction With Antacids Do not take the bisacodyl delayed-release tablet, USP within one hour of taking an antacid.

WARNINGS The flavor packs are for use with the accompanying 4 liter bottle. No additional ingredients, e.g., flavorings, should be added to the solution. TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) ® with flavor packs should be used with caution in patients with severe ulcerative colitis. Use of TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in 1 child and hypokalemia has been reported in 3 children. PRECAUTIONS General: Patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration should be observed during the administration of TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) , especially if it is administered via nasogastric tube. If a patient experiences severe bloating, distention or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms abate. If gastrointestinal obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration of TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) . Information for Patients: TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) produces a watery stool which cleanses the bowel prior to examination. Prepare the solution according to the instructions on the bottle. It is more palatable if chilled. For best results, no solid food should be consumed during the 3 to 4 hour period before drinking the solution, but in no case should solid foods be eaten within 2 hours of taking TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) . Adults drink 240 mL (8 oz.) every 10 minutes. Pediatric patients (aged 6 months or greater) drink 25 mL/kg/hour. Rapid drinking of each portion is better than drinking small amounts continuously. The first bowel movement should occur approximately one hour after the start of TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) administration. You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort or distention occurs, stop drinking temporarily or drink each portion at longer intervals until these symptoms disappear. Continue drinking until the watery stool is clear and free of solid matter. This usually requires at least 3 liters. Any unused portion should be discarded. Use of TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in 1 child and hypokalemia has been reported in 3 children. Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenic and reproductive studies with animals have not been performed. Pregnancy: Category C. Animal reproduction studies have not been conducted with TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) . It is also not known whether TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) should be given to a pregnant woman only if clearly needed. Pediatric Use: Safety and effectiveness of TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) ® with flavor packs in pediatric patients aged 6 months and older are supported by evidence from adequate and well-controlled clinical trials of a similar product in adults with additional safety and efficacy data from published studies of similar formulations.

WARNINGS Included as part of the "PRECAUTIONS" Section PRECAUTIONS Serious 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 ofadverse events of seizure, arrhythmias, and renal impairment. [see DRUG INTERACTIONS] Seizures 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) inthese patients. Renal 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. Cardiac 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. Ischemic Colitis 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.Ifpatients develop severe abdominal pain or rectal bleeding, patients should be evaluated as soon as possible. Patients With Significant Gastrointestinal Disease 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. Aspiration Use with caution in patients with impaired gag reflex andpatients prone to regurgitation or aspiration. Such patients should be observed during administration of the GaviLyte-H and bisacodyl delayed-release tablet, USP solution. Patient Counseling Information See PATIENT INFORMATION 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]. Inform patients that 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. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility 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. Use In Specific Populations Pregnancy 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. Nursing 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. Pediatric Use Safety and effectiveness in pediatric patients has not been established. Geriatric 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].