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Cough and Cold Medicines for Infants and Children Withdrawn

(Posted on 10/11/07)

The AAP applauds the decision of pharmaceutical companies to withdraw cough and cold medicines for infants and children under 2 years of age. Evidence from controlled trials show that these products are not effective in children under 6 and can have potentially serious side effects. Dosage guidelines for cold and cold mixtures are extrapolated from adult data and thus inaccurate for children. According to the Consumer Healthcare Products Association (CHPA), the cough and cold medicines that are being withdrawn are:

  • Dimetapp(R) Decongestant Plus Cough Infant Drops,
  • Dimetapp(R) Decongestant Infant Drops,
  • Little Colds(R) Decongestant Plus Cough,
  • Little Colds(R) Multi-Symptom Cold Formula,
  • PEDIACARE(R) Infant Drops Decongestant (containing pseudoephedrine),
  • PEDIACARE(R) Infant Drops Decongestant & Cough (containing pseudoephedrine),
  • PEDIACARE(R) Infant Dropper Decongestant (containing phenylephrine),
  • PEDIACARE(R) Infant Dropper Long-Acting Cough,
  • PEDIACARE(R) Infant Dropper Decongestant & Cough (containing phenylephrine),
  • Robitussin(R) Infant Cough DM Drops,
  • Triaminic(R) Infant & Toddler Thin Strips(R) Decongestant,
  • Triaminic(R) Infant & Toddler Thin Strips(R) Decongestant Plus Cough,
  • TYLENOL(R) Concentrated Infants' Drops Plus Cold,
  • TYLENOL(R) Concentrated Infants' Drops Plus Cold & Cough.

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    Pictured below are the products being withdrawn from the market.

    More information is available at otcsafety.com.