MOVIPREP (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

MoviPrep® is supplied in powdered form. MoviPrep is administered as an oral solution after reconstitution.

NDC 54868-5890-0, MoviPrep, single use carton.

Each carton contains a disposable container for reconstitution of MoviPrep® and an inner carton containing 4 pouches (2 of pouch A and 2 of pouch B).

Rx only

STORAGE
Store carton/container at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). When reconstituted, store upright and keep solution refrigerated. Use within 24 hours.

17 PATIENT COUNSELING INFORMATION

Important Precautions Regarding MOVIPREP

MoviPrep produces a watery stool which cleanses the colon before colonoscopy. It is recommended that patients receiving MoviPrep be advised to adequately hydrate before, during, and after the use of MoviPrep. Patients may have clear soup and/or plain yogurt for dinner, finishing the evening meal at least one hour prior to the start of MoviPrep treatment. No solid food should be taken from the start of MoviPrep treatment until after the colonoscopy.

What Patients Should Know About Adverse Reactions

The first bowel movement may occur approximately 1 hour after the start of MoviPrep administration. Abdominal bloating and distention may occur before the first bowel movement. If severe abdominal discomfort or distention occurs, stop drinking temporarily or drink each portion at longer intervals until these symptoms disappear.

Manufactured by:
Norgine B.V.
Hogehilweg 7
1101 CA Amsterdam Zuidoost
Netherlands

For:
Salix Pharmaceuticals, Inc.
Morrisville, NC 27560

© 2006 Salix Pharmaceuticals, Inc.
VENART xxx-x/June 09

Product protected by U.S. Patent No. 7169381 and other pending applications

PRINCIPAL DISPLAY PANEL

MoviPrep®
(PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution)

Phenylketonurics:
contains phenylalanine – a maximum of 2.33 mg per course of treatment.

This carton containsOne container for reconstitution of MoviPrep®

image of package labelimage of package label
MOVIPREP polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5890(NDC:65649-201)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5890-0 1 KIT (KIT) in 1 CONTAINER None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 2 POUCH 2 L
Part 2 2 POUCH 2 L
Part 1 of 2
POUCH A polyethylene glycol 3350,sodium sulfate,anhydrous,sodium chloride,potassium chloride solution
Product Information
Item Code (Source) NDC:54868-5890
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 3350 100 g in 1 L
SODIUM SULFATE (SODIUM CATION) SODIUM SULFATE 7.5 g in 1 L
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 2.69 g in 1 L
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 1.015 g in 1 L
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
LEMON
Packaging
# Item Code Package Description Multilevel Packaging
1 1 L in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021881 05/30/2008
Part 2 of 2
POUCH B ascorbic acid, sodium ascorbate solution
Product Information
Item Code (Source) NDC:54868-5890
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 4.7 g in 1 L
SODIUM ASCORBATE (SODIUM CATION) SODIUM ASCORBATE 5.9 g in 1 L
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 1 L in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021881 05/30/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021881 05/30/2008
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 11/2009 Physicians Total Care, Inc.

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