INDICATION

MoviPrep is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.

IMPORTANT SAFETY INFORMATION - MOVIPREP

• Do not take MOVIPREP^® (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) if you have a gastrointestinal (GI) obstruction (a blockage in your bowel), bowel perforation (an opening in the wall of your stomach or intestine), gastric retention (problems with food and fluid emptying from your stomach), ileus (bowel muscle unable to move stomach contents), toxic colitis (damage to the thickness of the intestinal wall) or toxic megacolon (an extremely dilated or distended colon with fever and/or abdominal pain at times), or if you have a known allergy to MOVIPREP or any of its components.
• It is important to drink sufficient liquids before, during, and after the use of MOVIPREP. Liquid and blood salt changes can lead to serious side effects including abnormal heartbeats that can cause death, seizures, and kidney problems. Talk to your doctor before taking MOVIPREP if you take any medications that increase the risk of blood salt abnormalities or if you have known or suspected low blood salt (sodium) level (hyponatremia).
• If you have kidney problems or if you take medication that affects kidney function, talk to your doctor before taking MOVIPREP.
• If you have suspected bowel blockage or a suspected opening in the wall of your stomach or intestine, talk to your doctor before taking MOVIPREP.
• Talk to your doctor before taking MoviPrep if you have stomach or bowel problems, including ulcerative colitis.
• Talk to your doctor before taking MOVIPREP if you have problems swallowing, if you have gastric reflux, or if you are predisposed to aspiration.
• If you have a condition that destroys red blood cells called glucose-6-phosphate dehydrogenase (G6PD) deficiency, talk to your doctor before taking MOVIPREP.
• Please be advised that MOVIPREP contains aspartame equivalent to 131 mg of phenylalanine per treatment. Before taking MoviPrep, tell your doctor if you are on a diet low in phenylalanine.
• Tell your doctor about all other medicines you take. MoviPrep may affect how other medicines work.
• Do not take oral medications within 1 hour before or after starting each dose of MOVIPREP. Do not take other laxatives while taking MOVIPREP and do not take MOVIPREP with starch based thickeners.
• If you are pregnant, planning to become pregnant, breastfeeding or plan to breastfeed, talk to your doctor before taking MOVIPREP.
• In clinical studies with MOVIPREP, the most common side effects for split dosing were malaise (feeling uneasy), nausea, stomach (abdominal) pain, vomiting, and upper stomach pain. The most common side effects for evening only dosing were stomach swelling (abdominal distension), anal discomfort, thirst, nausea, stomach (abdominal) pain, sleep disorder, rigors (body shakes), hunger, malaise (feeling uneasy), vomiting, and dizziness.

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For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-321-4576
Fax: 1-510-595-8183
Email: salixmc@dlss.com