HalfLytely and Bisacodyl Tablets Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults.

The recommended HalfLytely and Bisacodyl Tablets Bowel Prep Kit oral dosage regimen for adults on the day prior to colonoscopy is as follows:

• Take two 5 mg bisacodyl delayed release tablets with water. Do NOT chew or crush the tablets.
• 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.

Dosage Forms And Strengths

• Two pink, round, enteric coated 5 mg bisacodyl delayed release tablets, stamped “BRA”
• One 2 liter HalfLytely bottle with powder for reconstitution

Storage And Handling

Each HalfLytely and Bisacodyl Tablets Bowel Prep Kit contains:

One pack of bisacodyl delayed release tablets containing two pink, round, enteric coated 5 mg bisacodyl delayed release tablets, stamped “BRA”

One 2 liter bottle of HalfLytely (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 1 gram of flavoring ingredient (if applicable). After adding 2 liters of water, the reconstituted HalfLytely 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.

Lemon-Lime HalfLytely and Bisacodyl Tablets Bowel Prep Kit contains 1 gram lemon-lime flavoring ingredient. HalfLytely and Bisacodyl Tablets Bowel Prep Kit with Flavor Packs contains 3 packs (1gram each Cherry, Lemon-Lime and Orange flavors).

Storage

Store at 20-25°C (68-77°F). Excursions permitted between 15-30°C (59-86°F). The reconstituted HalfLytely solution, which may be refrigerated, should be used within 48 hours.

Lemon-Lime HalfLytely and Bisacodyl Tablets Bowel Prep Kit.................................NDC 52268-502-02

HalfLytely and Bisacodyl Tablets Bowel Prep Kit with Flavor Packs.........................NDC 52268-520-05

Distributed by Braintree Laboratories, Inc. Braintree, MA 02185. FDA Rev date: 9/21/2007

Bookmark this page: