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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  04/18/2002
Trade Name:  Advil Cold Suspension
Generic Name or Proper Name (*):  ibuprofen/ pseudoephedrine
Indications Studied:  Temporary relief of nasal and sinus congestion, headache, stuffy nose, sore throat, minor aches and pains, and fever
Label Changes Summary:  * Information on the over-the-counter use in pediatric patients 2 to 11 years of age
Product Labeling:  Labeling  Opens a new window
Sponsor:  Whitehall
Pediatric Exclusivity Granted Date:  09/19/2001
Therapeutic Category:  Decongestant; anti-inflammatory