Johnson & Johnson Voluntarily Recalls Some Infant Cough Medications

By: Patrick Claybon Email
By: Patrick Claybon Email

Johnson & Johnson announced Thursday that it would voluntarily recall certain infant cough and cold products that have been in use for decades.

The Consumer Health Care Products Association submitted several suggestions to Johnson & Johnson involving labeling on over the counter infant drugs and several products all aimed at infants.

Now, Johnson & Johnson is taking part in a voluntary recall of the drugs in order to augment the dosing instructions to improve safety.

Pharmacist Bill Roberts said, "The labeling change that is proposed right now is that these products have not been shown to be safe and effective in children under the age of six."

The voluntary recall comes before the FDA review scheduled for cough and cold medicine in a couple of weeks. Johnson & Johnson cites "Rare instances of abuse" that have led to the overdoses on record.

Dr. James Wiley, with Dothan Pediatric said, "Most parents don't realize for example that with the Tylenol Preparations that have cold and cough medications, you can’t add other cold and cough medications to that."

In the meantime, there are other options for parents who want to give their infants medication if you are unable to find any of the mainstays.

"Parents can buy an ear syringe, [if] they don’t have the one that the baby was sent home from the hospital with,” Wiley said. “Probably the best device is an ear syringe that you can get at a pharmacy."

Products not made by Johnson & Johnson, but still aimed at infants will remain on the shelves at pharmacies at least until the FDA makes a decision later this month.

"That concern would apply to those products as well,” Roberts says. “So before you go, look for alternative products; it's best that you consult your physician first."

It’s important to reiterate that these medicines are fine; it's just a revision of the labeling information for infants. Adults and children age 2 and up have little to worry about.

The medicines that are being withdrawn are: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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