COMPOSITION

FLEET® Prep Kit 1 contains:

  1. FLEET® Phospho-soda®--1.5 fl. oz. (45 mL) Active Ingredients : Each teaspoon (5 mL) contains monobasic sodium phosphate monohydrate 2.4g and dibasic sodium phosphate heptahydrate 0.9g.
  2. FLEET® Bisacodyl Tablets--4 laxative tablets. Active Ingredient : Each enteric-coated tablet contains bisacodyl, USP, 5 mg.
  3. FLEET® Bisacodyl Suppository--1 laxative suppository. Active Ingredient : Each suppository contains bisacodyl, USP, 10 mg.
  4. 1 Patient Instruction Sheet.

FLEET® Prep Kit 2 contains:

  1. FLEET® Phospho-soda®--1.5 fl. oz. (45 mL).
  2. FLEET® Bisacodyl Tablets--4 tablets.
  3. FLEET® Bagenema--1.
  4. 1 Patient Instruction Sheet.

FLEET® Prep Kit 3 contains:

  1. FLEET® Phospho-soda® --1.5 fl. oz. (45 mL)
  2. FLEET® Bisacodyl Tablets--4 tablets.
  3. FLEET® Bisacodyl Enema 1.25 fl. oz. (37 mL)--1 laxative enema. Active Ingredient : Each 30 mL delivered dose contains bisacodyl, USP 10 mg.
  4. 1 Patient Instruction Sheet.

ACTIONS AND USES

Bowel Cleansing System

INDICATIONS

For use as part of a bowel cleansing regimen in preparation of the colon for radiology (prior to barium enemas or I.V.P.'s), surgery, and many endoscopic and colonoscopic procedures.

DO NOT EXCEED RECOMMENDED DOSE UNLESS DIRECTED BY A PHYSICIAN. SERIOUS SIDE EFFECTS MAY OCCUR FROM EXCESS DOSAGE.

Each recommended dose (1.5 fl. oz.) (45 mL) of FLEET® Phospho-soda® contains 5004 mg sodium. Persons on a sodium restricted diet or with kidney disease should consult a health professional before use.

Bisacodyl products may cause abdominal discomfort, faintness, and cramps.

Swallow tablets whole. Do not chew tablets or give to persons who cannot swallow without chewing unless directed by a physician. Do not take tablets within 1 hour after taking antacids, milk, or milk products.

Keep this and all drugs out of the reach of children. In case of accidental overdose or ingestion, seek professional assistance or contact a Poison Control Center immediately.

PROFESSIONAL USE

Do not use in patients with congenital megacolon, bowel obstruction, ascites or congestive heart failure.

Use with caution in patients with impaired renal function, pre-existing electrolyte imbalances or with debilitated patients.

Since FLEET® Phospho-soda® contains sodium phosphates, there is a risk of elevated serum levels of sodium and phosphate and decreased levels of calcium and potassium and consequent hypocalcemia, hyperphosphatemia, hypernatremia, and acidosis may occur.

Additional fluids by mouth are recommended with all bowel cleansing dosages.

If any of these complications occur following administration of FLEET® Phospho-soda®, immediate corrective action should be taken to restore electrolyte balance with appropriate fluid replacements. Calcium, magnesium, and phosphorus levels should be carefully monitored. See individual listings FLEET® Phospho-soda®, and FLEET® Bisacodyl Laxatives for additional .

THESE KITS SHOULD NOT BE USED BY PATIENTS UNDER 12 YEARS OF AGE.

PRECAUTIONS

DO NOT EXCEED RECOMMENDED DOSE UNLESS DIRECTED BY A PHYSICIAN, AS SERIOUS SIDE EFFECTS MAY OCCUR. IF THERE IS NO BOWEL MOVEMENT AFTER MAXIMUM DOSAGE, CONTACT A PHYSICIAN AS DEHYDRATION COULD OCCUR.

DOSAGE AND ADMINISTRATION

SEE PATIENT INSTRUCTION SHEET FOR 18, 24, AND 48 HOUR PREPARATION SCHEDULE IN EACH KIT. The patient should open and read the enclosed directions and labels at least 48 hours in advance of examination.

HOW SUPPLIED

See " " for contents of each kit.

Shipping Unit: 48 FLEET® Prep Kits per carton.

For full prescribing information on specific products, see individual listings (FLEET® Phospho-soda®, FLEET® Bisacodyl Laxatives).

IS THIS PRODUCT OTC?

Yes.