Children’s Cough, Cold Medicines
Withdrawn from Market

Manufacturers Cite Safety Risk Posed by Dosage Miscalculation

Several manufacturers of cough and cold medicines for infants and children under 2 years of age have voluntarily withdrawn their products from the market due to safety concerns. Evidence from controlled trials shows that these products may carry serious safety risks, including fatal overdose, due to dosage miscalculation.

McNeil Consumer Healthcare, Novartis and Wyeth--manufacturers of the children's cough and cold medicines--have voluntarily pulled the following products from store shelves:

  • Dimetapp® Decongestant Infant Drops

  • Dimetapp® Decongestant Plus Cough Infant Drops

  • Little Colds® Decongestant Plus Cough

  • Little Colds® Multi-Symptom Cold Formula

  • PEDIACARE® Infant Drops Decongestant (PSE)

  • PEDIACARE® Infant Drops Decongestant & Cough (PSE)

  • PEDIACARE® Infant Dropper Decongestant (PE)

  • PEDIACARE® Infant Dropper Long-Acting Cough

  • PEDIACARE® Infant Dropper Decongestant & Cough (PE)

  • Triaminic® Infant & Toddler Thin Strips Decongestant

  • Triaminic® Infant & Toddler Thin Strips Decongestant Plus Cough

  • TYLENOL® Concentrated Infants' Drops Plus Cold

  • TYLENOL® Concentrated Infants' Drops Plus Cold & Cough

Parents are urged to treat their children's colds and upper respiratory infections by making sure their child gets plenty of rest and fluids, and may use a bulb syringe--and in some cases, saline nose drops--to clear their child's nasal passages. Parents should also contact their child's physician if they have any questions or concerns.

Note: The voluntary withdrawal affects only infant medicines--not those intended and labeled for use in children ages 2 and older.


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