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U.S. Department of Health and Human Services

Safety

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Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use Label Change

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