Label Changes for:
Motrin
April 2009
Changes have been made to the WARNINGS sections of the safety label.
- Children’s Motrin (100 mg/5 mL ibuprofen) suspension [OTC]
- Motrin IB (200 mg ibuprofen) tablets [OTC]
- Motrin Infants’ Drops (50 mg/1.25 mL ibuprofen oral suspension) [OTC]
- Motrin Junior Strength (100 mg ibuprofen) chewable tablets & Junior Strength Motrin (100 mg ibuprofen) tablets [OTC]
Label approved 04/24/2009 is not available on Drugs@FDA
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009
| 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. |
| Sections Modified |
Summary of Changes to Contraindications and Warnings |
| WARNINGS |
WARNINGS
|
