Important Administration Instructions

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Correct fluid and electrolyte abnormalities before treatment with OsmoPrep [see Warnings and Precautions (5.1)].

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Clear liquids must be consumed before, during and after taking OsmoPrep [see Dosage and Administration (2.1), Warnings and Precautions (5.1)].

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Do not administer OsmoPrep within 7 days of a previous use.

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Two doses of OsmoPrep are required for a complete preparation for colonoscopy: the first dose the evening before the colonoscopy and the second dose on the morning of the colonoscopy [see Dosage and Administration (2.2)].

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Consume only clear liquids (no solid food) from the start of OsmoPrep treatment until after the colonoscopy.

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Do not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material.

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Do not take other laxatives while taking OsmoPrep, particularly additional sodium phosphate-based purgative or enema products [see Drug Interactions (7.3)].

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Do not take oral medications within 1 hour before or after starting each dose of OsmoPrep [see Drug Interactions (7.2)].

Dosage Regimen

Instruct adult patients that on the day before their colonoscopy, they can consume a light breakfast consisting of clear soup and/or plain yogurt (no solid foods) before noon, followed by only clear liquids until after the colonoscopy.

The recommended dose of OsmoPrep for colon cleansing for adult patients is 32 tablets (48 grams of sodium phosphate)

taken orally with a total of 2 quarts of clear liquids in the following manner:

The evening before the colonoscopy: Take 4 OsmoPrep tablets with 8 ounces of clear liquids every 15 minutes for a total

of 20 tablets.

On the day of the colonoscopy starting 3 to 5 hours before the procedure: Take 4 OsmoPrep tablets with 8 ounces of clear

liquids every 15 minutes for a total of 12 tablets.