Label Changes for:
MoviPrep (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) Oral solution
Changes have been made to the PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- 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.
|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.|
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...