COLYTE^® and COLYTE^®- FLAVORED are indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.

COLYTE^® or COLYTE^®-FLAVORED can be administered orally or by nasogastric tube. Patients should fast at least 3 hours prior to administration. A one hour waiting period after the appearance of clear liquid stool should be allowed prior to examination to complete bowel evacuation. No foods except clear liquids should be permitted prior to examination after COLYTE^® or COLYTE^®-FLAVORED administration.

Oral

The recommended adult oral dose is 240 ml (8 fl. oz.) every 10 minutes (see PATIENT INFORMATION section). Lavage is complete when fecal discharge is clear. Lavage is usually complete after the ingestion of 3-4 liters.

Nasogastric Tube

COLYTE^® or COLYTE^®-FLAVORED is administered at a rate of 20-30 mL per minute (1.2-1.8 L/hour).

Preparation Of Colyte^® or Colyte^®-Flavored Solution

This preparation can be used with or without the flavor packs.

1. To add flavor, tear open one flavor pack at the indicated marking and pour contents into the bottle BEFORE reconstitution. Discard unused flavor packs.
2. SHAKE WELL to incorporate flavoring into the powder.
3. Add tap water to FILL line. Replace cap tightly and mix or shake well until all ingredients have dissolved. (No other additional ingredients, e.g. flavorings, should be added to the solution.)

Note: If not using flavor packs, omit steps one and two, above.

COLYTE^® and COLYTE^®-FLAVORED are supplied in 4 liter (NDC 0091-4401-23 and NDC 0091-4403-05, respectively) and 18 oz. (NDC 0091-4401-49 and NDC 0091-4403-13, respectively) bottles in powdered form, for oral administration as a solution. Each contains the following:

• 4 liter, (NDC 0091-4401-23 and NDC 0091-4403-05): polyethylene glycol 3350 240 g, sodium chloride 5.84 g, potassium chloride 2.98 g, sodium bicarbonate 6.72 g, sodium sulfate (anhydrous) 22.72 g, flavor ingredients (COLYTE^®-FLAVORED only) 1.85 g, in a bottle.



• 18 oz., (NDC 0091-4401-49 and NDC 0091-4403-13): polyethylene glycol 3350 227.10 g, sodium chloride 5.53 g, potassium chloride 2.82 g, sodium bicarbonate 6.36 g, sodium sulfate (anhydrous) 21.50 g, flavor ingredients (COLYTE^®-FLAVORED only) 1.75 g, in a bottle.

Strorage: Store powder at controlled room temperature 15°-30°C (59°-86°F).

Keep reconstituted solution refrigerated. Use within 48 hours. Discard unused portions.

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