Braintree Laboratories, Inc.

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The recommended HalfLytely and Bisacodyl Tablet Bowel Prep Kit 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 with water. Do NOT chew or crush the tablet. No antacids should be taken within one hour of taking the bisacodyl delayed-release tablet. Prepare the HalfLytely 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 HalfLytely 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 HalfLytely 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 HalfLytely solution temporarily or drink each portion at longer intervals until your symptoms improve. Consume only clear liquids after taking the HalfLytely solution until your colonoscopy.

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Active Duodenal Ulcer —The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

Maintenance of Healed Duodenal Ulcer —The recommended oral dosage for adults is 150 mg once daily at bedtime.

Gastroesophageal Reflux Disease —The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

Active Benign Gastric Ulcer—The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

Each mL of Axid Oral Solution contains 15 mg of nizatidine. In adults, Axid Oral Solution may be substituted for any of the above indications using equivalent doses of the oral solution.

Pediatric Dosing—Each mL of oral solution contains 15 mg of nizatidine. Axid Oral Solution is indicated for pediatric patients 12 years of age or older. For pediatric patients 12 years of age and older, the dosage of nizatidine is 150 mg b.i.d. (2 tsp, b.i.d.)

The following dosage recommendations are provided:

Erosive Esophagitis—For pediatric patients 12 years or older, the dosage is 150 mg b.i.d. (300 mg/d). The maximum daily dose for nizatidine PO is 300 mg/d. The dosing duration may be up to eight weeks.

Gastroesophageal Reflux Disease—For pediatric patients 12 years or older, the dosage is 150 mg b.i.d. (300 mg/d). The maximum daily dose for nizatidine PO is 300 mg/d. The dosing duration may be up to eight weeks.

Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency —The dose for patients with renal dysfunction should be reduced as follows:

Active Duodenal Ulcer, GERD, and Benign Gastric Ulcer Creatine Clearance Dose 20-50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy Creatine Clearance Dose 20-50 mL/min 150 mg every other day <20 mL/min 150 mg every 3 days

Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

Based on the pharmacokinetic data in elderly patients with renal impairment, pediatric patients with creatinine clearances less than 50 mL/min should have their dose of nizatidine reduced accordingly. The clinical effects of this dose reduction in pediatric patients with renal failure have not been evaluated.

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SUPREP Bowel Prep Kit should be taken as a split-dose oral regimen.

The dose for colon cleansing requires administration of two bottles of SUPREP Bowel Prep Kit. Each bottle is administered as 16 ounces of diluted SUPREP solution with an additional 1 quart of water taken orally. The total volume of liquid required for colon cleansing (using two bottles) is 3 quarts (approximately 2.8 L) taken orally prior to the colonoscopy in the following way:

Split-Dose (Two-Day) Regimen

Day prior to colonoscopy:

A light breakfast may be consumed, or have only clear liquids on the day before colonoscopy. Avoid red and purple liquids, milk, and alcoholic beverages. Early in the evening prior to colonoscopy: pour the contents of one bottle of SUPREP Bowel Prep Kit into the mixing container provided. Fill the container with water to the 16 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour.

Day of colonoscopy:

Have only clear liquids until after the colonoscopy. Avoid red and purple liquids, milk, and alcoholic beverages. The morning of colonoscopy (10 to 12 hours after the evening dose): pour the contents of the second bottle of SUPREP Bowel Prep Kit into the mixing container provided. Fill the container with water to the 16 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour. Complete all SUPREP Bowel Prep Kit and required water at least two hours prior to colonoscopy or as directed by physician.

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2.1 Dosing Overview

There are two dosing regimens. Each requires two separate dosing times:

Split-Dose (2-Day) [see Dosage and Administration (2.2)] Day-Before (1-Day) [see Dosage and Administration (2.3)].

Both Suclear dosing regimens require administration of Suclear using one 6-oz bottle of oral solution (containing sodium sulfate, potassium sulfate, and magnesium sulfate) diluted with water to 16-oz, followed by a 2-L jug of powder (polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride) dissolved in water. Additional fluids must be consumed in both dosing regimens [see Dosage and Administration (2.2, 2.3)]. Instruct patients to consume only clear liquids (no solid food or milk) and to avoid alcohol on the day before colonoscopy until after completion of the colonoscopy. [see Warnings and Precautions (5.1)].

2.2 Split-Dose (2-Day) Regimen (Preferred Method)

The Split-Dose regimen is the preferred dosing method. Instruct patients to take two separate doses in conjunction with fluids, as follows:

Dose 1 - Evening before the colonoscopy (10 to 12 hours prior to Dose 2)

Dilute the 6-oz oral solution prior to use by pouring the entire contents of the bottle into the 16-oz mixing container and then filling the container with cool water to the fill line and mix Drink the entire solution in the container. It is best to complete drinking the solution within 20 minutes. Refill the container with 16 oz of water to the fill line and drink it over the next 2 hours. Refill the container with 16 oz of water to the fill line and finish drinking it before going to bed.

Dose 2 - Next morning on the day of the colonoscopy (start at least 3 ½ hours prior to colonoscopy)

Dissolve the powder of Dose 2 by adding water to the fill line on the jug. Shake the jug until all the powder is dissolved. The solution can be used with or without the addition of a flavor pack. Flavor packs are available in Cherry, Lemon-Lime, Orange and Pineapple. When dissolved in water to a volume of 2 liters, the solution is clear and colorless. The solution may be refrigerated after adding water. The solution should be used within 48 hours of reconstitution. Using the 16-oz container provided with the kit, drink all the solution in the jug at a rate of one 16-oz container every 20 minutes (this is four 16-oz containers over a period of one and a half hours). Complete drinking the solution at least 2 hours before the colonoscopy. Consume only clear liquids until 2 hours prior to colonoscopy. Thereafter, nothing should be consumed until the completion of colonoscopy.

2.3 Day-Before (1-Day) Regimen (Alternative Method)

The Day-Before regimen is the alternative dosing method for patients for whom the Split-Dosing regimen is inappropriate. Instruct patients to take two separate doses in conjunction with fluids as follows:

On the evening before the colonoscopy:

Dose 1 (Begin at least 3 ½ hours prior to bedtime)

Dilute the 6-oz oral solution prior to use by pouring the entire contents of the bottle into the 16-oz mixing container and then filling the container with cool water to the fill line and mix. Drink the entire solution in the container. It is best to complete drinking the solution within 20 minutes. Refill the container with 16 oz of water to the fill line and drink it over the next 2 hours.

Dose 2 (Approximately 2 hours after starting Dose 1)

Dissolve the powder of Dose 2 by adding water to the fill line on the jug. Shake the jug until all the powder is dissolved. The solution can be used with or without the addition of a flavor pack. Flavor packs are available in Cherry, Lemon-Lime, Orange and Pineapple. When dissolved in water to a volume of 2 liters, the solution is clear and colorless. The solution may be refrigerated after adding water. The solution should be used within 48 hours of reconstitution. Using the 16-oz container provided with the kit, drink all the solution in the jug at a rate of one 16-oz container every 20 minutes (This is four 16-oz containers over a period of one and a half hours). Refill the container with 16 oz of water to the fill line and finish drinking it before going to bed. Consume only clear liquids until 2 hours prior to colonoscopy. Thereafter, nothing should be consumed until the completion of colonoscopy.

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2.1 Dosage Overview

GoLYTELY, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion [see Dosage and Administration (2.2), Warnings and Precautions (5.8)]. The 4 liter reconstituted GoLYTELY solution contains: 236 grams of polyethylene glycol (PEG) 3350, 22.74 grams sodium sulfate (anhydrous), 6.74 grams of sodium bicarbonate, 5.86 grams of sodium chloride, and 2.97 grams of potassium chloride. GoLYTELY is also available with pineapple flavor.

2.2 Administration Instructions Prior to Dosage

On the day prior to the colonoscopy, instruct patients to:

Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast. Early in the evening prior to colonoscopy, fill the supplied container containing the GoLYTELY powder with lukewarm water (to facilitate dissolution) to the 4 liter fill line. The solution is clear and colorless when reconstituted to a final volume of 4 liters. After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. When reconstituted use within 48 hours.

2.3 Dosage

The following is the recommended dose of reconstituted GoLYTELY solution for adults. Instruct patients they may consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. The solution is more palatable if chilled prior to administration.

Adults: Instruct patients to drink a total of up to 4 liters at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. For NGT, rate is 20-30 mL per minute (1.2 – 1.8 liters per hour).

The first bowel movements should occur approximately one hour after the start of GoLYTELY administration. Continue drinking until the watery stool is clear and free of solid matter.

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2.1 Dosage Overview

NuLYTELY, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion [see Dosage and Administration (2.2), Warnings and Precautions (5.8)]. The 4 liter reconstituted NuLYTELY solution contains: 420 grams of polyethylene glycol (PEG) 3350, 5.72 grams of sodium bicarbonate, 11.2 grams of sodium chloride, and 1.4 grams of potassium chloride. NuLYTELY may be used with or without one of the supplied flavor packs.

2.2 Administration Instructions Prior to Dosage

On the day prior to the colonoscopy, instruct patients to:

Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast. If adding a NuLYTELY flavor pack, pour the contents of the 2 gram flavor powder (i.e., cherry, lemon-lime, orange or pineapple) into the container prior to reconstitution. No additional flavorings should be added. Discard unused flavor packs. The NuLYTELY flavor packs are for use only in combination with the contents of the accompanying 4 liter container. Early in the evening prior to colonoscopy, fill the supplied container containing the NuLYTELY powder (and if applicable, a flavor powder) with lukewarm water (to facilitate dissolution) to the 4 liter fill line. The solution is clear and colorless when reconstituted to a final volume of 4 liters. After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. When reconstituted use within 48 hours.

2.3 Dosage

The following is the recommended dose of reconstituted NuLYTELY solution for adults and pediatric patients > 6 months. Instruct patients they may consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. The solution is more palatable if chilled prior to administration.

Adults: Instruct patients to drink a total of up to 4 liters at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. For NGT, rate is 20-30 mL per minute (1.2 – 1.8 liters per hour). Pediatric Patients > 6 Months: Pediatric patients should drink 25 mL/kg/hour until the stool is watery, clear, and free of solid matter. If pediatric patients are unable to drink the reconstituted NuLYTELY solution, the solution may be given by nasogastric (NGT). NGT administration is at the rate of 25 mL/kg/hour.

The first bowel movements should occur approximately one hour after the start of NuLYTELY administration. Continue drinking until the watery stool is clear and free of solid matter.