MoviPrep (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) Oral solution

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

August 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Contains Phenylalanine

• Phenylketonurics: Contains aspartame 233 mg per treatment which corresponds to 131 mg of phenylalanine per treatment (after hydrolysis of the aspartame molecule in-vivo to aspartic acid and phenylalanine).

 

November 2010

Summary View

ADVERSE REACTIONS

Postmarketing Experience

• Hypersensitivity reactions including anaphylaxis (some of which were severe, including shock), rash, urticaria, pruritus, lip, tongue and facial swelling, dyspnea, chest tightness and throat tightness. Fever, chills and dehydration.
   

November 2008

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Summary View

Sections Modified

PATIENT PACKAGE INFORMATION - (revisions to immediate container and carton labels)

• Step 1
  • ...After finishing 1 liter of MoviPrep solution, take the second Pouch A and second Pouch B. empty the contents into the disposable container. Add another liter of lukewarm drinking water to mix the second liter of MoviPrep solution.
• Step 3
  • MoviPrep solution is taken orally in one of the following ways...