Several companies voluntarily withdraw infant cough and cold OTCs

October 12, 2007

Several manufacturers withdraw over-the-counter cough and cold products

The Consumer Healthcare Products Association (CHPA) has announced on behalf of several drug companies the voluntary withdrawal of oral over-the-counter cough and cold products that are labeled for use in infants. The action is in response to reports of misuse that has led to overdose in this age group. In preparation for a joint FDA advisory committee meeting on Oct. 18 and 19, CHPA and its member companies have asked the FDA to strengthen the labels on all oral OTC children's cough and cold medicines from "ask the doctor" before using to "do not use" in children under two years old. CHPA said that most parents and caregivers do use the products safely; however, it is important that parents read OTC labels carefully and use the medications only as directed. The withdrawn products are:

  • Dimetapp Decongestant Plus Cough Infant Drops
  • Dimetapp Decongestant Infant Drops
  • Little Colds Decongestant Plus Cough
  • Little Colds Multi-Symptom Cold Formula
  • PEDIACARE Infant Drops Decongestant (containing pseudoephedrine)
  • PEDIACARE Infant Drops Decongestant & Cough (containing pseudoephedrine)
  • PEDIACARE Infant Dropper Decongestant (containing phenylephrine)
  • PEDIACARE Infant Dropper Long-Acting Cough
  • PEDIACARE Infant Dropper Decongestant & Cough (containing phenylephrine)
  • Robitussin Infant Cough DM Drops
  • 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

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