The maker of Tylenol and PediaCare brands has voluntarily withdrawn all its infant cough and cold medicines from the market. This is in advance of an FDA meeting evaluating the safety of these medicines in children less than 2 years old. The company is also asking permission from the FDA to change the packaging of its other products from “ask your doctor” to “do not use” for children less than 2 years old.
The products being withdrawn from the market are:
- Concentrated Tylenol? Infants’ Drops Plus Cold
- Concentrated Tylenol? Infants’ Drops Plus Cold & Cough
- PediaCare? Infant Dropper Decongestant
- PediaCare? Infant Dropper Long-Acting Cough
- PediaCare? Infant Drops Decongestant (containing pseudoephedrine)
- PediaCare? Infant Dropper Decongestant & Cough
- PediaCare? Infant Drops Decongestant & Cough (containing pseudoephedrine)
They are also asking parents to discontinue use of the medicines in children less than 2 years old. They are providing coupons for parents at tylenol.com for other products to compensate parents who have purchased the infant products and can no longer use them.
Please see previous updates on this website for more information about issues of cough and cold medicines in young children.
