GAVILYTE-H AND BISACODYL

GaviLyte - H and bisacodyl delayed-release tablet, USP consists of PEG-3350, an osmotic laxative and bisacodyl, a stimulant laxative. Each GaviLyte - H and 5 mg bisacodyl delayed-release tablet, USP (Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet) consists of one 2 liter bottle of GaviLyte – H (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and one 5 mg bisacodyl, delayed-release tablet, USP. Bisacodyl delayed-release tablet, USP: Each pink, round, enteric coated bisacodyl delayed-release tablet, USP (debossed “N1”) contains 5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40. Inactive ingredients include lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, methacrylic acid copolymer, talc, titanium dioxide, triethyl citrate, D&C red # 27/phloxine aluminum lake, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, FD&C blue # 2/indigo carmine aluminum lake and FD&C yellow # 6/sunset yellow FCF aluminum lake. The bisacodyl delayed-release tablet, USP is administered orally prior to drinking the GaviLyte - H [see Dosage and Administration ( 2 )] . GaviLyte – H (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution): A white powder for reconstitution containing 210 grams of PEG-3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride and 2 grams of flavoring ingredients (if applicable). Flavor Packs are available in Cherry (containing artificial cherry flavor powder, maltodextrin and sodium saccharin), Lemon (containing natural lemon flavor powder, maltodextrin and sodium saccharin), and Orange (containing natural and artificial orange flavor powder, maltodextrin and sodium saccharin). This preparation can be used without the addition of a Flavor Pack. When dissolved in water to a volume of 2 liters, the GaviLyte - H solution is isosmotic, clear, and colorless. The GaviLyte - H solution is administered orally after taking the one bisacodyl delayed-release tablet, USP [see Dosage and Administration ( 2 )] .

INDICATIONS & USAGE GaviLyte - H and bisacodyl delayed-release tablet, USP is indicated for cleansing of the colon as a preparation for colonoscopy in adults. GaviLyte - H and bisacodyl delayed-release tablet, USP is a combination of PEG-3350, an osmotic laxative and bisacodyl, a stimulant laxative, indicated for cleansing of the colon as a preparation for colonoscopy in adults ( 1 )

DOSAGE & ADMINISTRATION The recommended GaviLyte - H and bisacodyl delayed-release tablet, USP oral dosage regimen for adults on the day prior to colonoscopy is as follows: No solid food or milk (clear liquids only) should be consumed on the day of the preparation. Take one 5 mg bisacodyl delayed-release tablet, USP with water. Do NOT chew or crush the tablet. No antacids should be taken within one hour of taking the bisacodyl delayed-release tablet, USP. Prepare the GaviLyte - H solution according to the instructions on the kit. Add flavor pack of choice (if applicable) to the 2 liter container. No additional ingredients (other than flavor packs provided) should be added to the solution. Prepare the GaviLyte - H solution by filling the container to the 2 liter mark with water. Cap the container. Shake to dissolve the powder. Wait for a bowel movement (or maximum of 6 hours) then drink the 2 liter GaviLyte - H solution at a rate of 8 ounces every 10 minutes. Drink all of the solution. If you have abdominal distention or discomfort, stop drinking the GaviLyte - H solution temporarily or drink each portion at longer intervals until your symptoms improve. Consume only clear liquids after taking the GaviLyte - H solution until your colonoscopy. See FULL PRESCRIBING INFORMATION for complete dosing and administration instructions ( 2 ) No solid food or milk (clear liquids only) should be consumed on the day of the preparation. Take one 5 mg bisacodyl tablet with water. Do NOT chew or crush. Dissolve the GaviLyte - H powder in 2 liters of water. Wait for a bowel movement (or maximum of 6 hours) then drink all the GaviLyte - H solution at a rate of 8 ounces every 10 minutes. Consume only clear liquids until the colonoscopy.

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

Most common adverse reactions (>3%) are overall discomfort, abdominal fullness, abdominal cramping, nausea, and vomiting, ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novel Laboratories, Inc. at 908-603-6000 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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% 6.2 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 ( 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 )] .

Some drugs (e.g., diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs) increase risk due to fluid and electrolyte changes ( 7.1 ) Oral medication administered within one hour of the start of drinking GaviLyte - H might not be absorbed fully. ( 7.2 ) Do not take the bisacodyl tablet within one hour of taking antacid ( 7.3 ) 7.1 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 ( 5.1 )] in patients taking these concomitant medications. 7.2 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. 7.3 Interaction with Antacids Do not take the bisacodyl delayed-release tablet within one hour of taking an antacid.