Label Changes for:
Motrin Junior Strength chewable tablets, 100 mg
October 2010
Changes have been made to the WARNINGS sections of the safety label.
August 2010
- Advil Allergy Sinus (ibuprofen 200 mg, chlorpheniramine maleate 2 mg, and pseudoephedrine 30 mg tablets) caplets
- Aleve (naproxen sodium) capsules
- Children’s Advil Cold (ibuprofen 100mg and pseudoephedrine 15 mg/5 mL) oral suspension
October 2010
- Children’s Motrin (ibuprofen) oral suspension 100 mg/5 mL
- Junior Strength Motrin (ibuprofen) tablets 100 mg
- Motrin IB (ibuprofen) tablets
- Motrin (ibuprofen) Junior Strength chewable tablets 100 mg
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2010 and October 2010
The following active ingredients for nonsteroidal anti-inflammatory drugs (NSAIDs): aspirin, carbaspirin calcium, choline salicylate, ibuprofen, ketoprofen, magnesium salicylate, naproxen sodium, and sodium salicylate, changed the labeling requirements
Drug Facts Labeling
- Warnings must include a stomach bleeding warning
or for Children's
-
Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding
