Dosing and concentration changes for over the counter (OTC) infants’ Acetaminophen


Acetaminophen is the most commonly used medication for pain and fever in infants and children. The drug is commonly known as Tylenol, but it is also widely sold under its generic name acetaminophen. Until just recently, there have been two forms of liquid acetaminophen available, children's, which is 160 mg per 5 mL and infants, which is actually more concentrated at 80 mg per 0.8 mL.

The Infants' formulation helps to maintain small volumes that infants can swallow.However, manufacturers will now only be making one concentration of the drug – the weaker 160 mg per 5 mL. Parents who may not be familiar with the change, which specifically affects the infant formulation (Infants' Tylenol, etc.), should be aware.

The transition, which has already started taking place, will provide consumers with only a single concentration of acetaminophen liquid, which will make it less confusing. A 2009 FDA Advisory Committee on acetaminophen safety made this recommendation in an effort to minimize medication errors where mix-ups happened between the two different concentrations.

The new 160 mg per 5 mL concentration for infants has already begun to appear on store shelves. However, it's important to be aware that both the old and the new concentrations might still be available for sale in some stores until the old concentration is completely exhausted. During the transition period, parents must be extremely cautious and read the drug facts label on the container, which provides dosing information specific to the product. Remember, although two products may be available as "infants acetaminophen" for a short period, different amounts of the liquid must be given.


For more information regarding the change in strength of pediatric liquid acetaminophen, visit:

Created on December 2, 2011

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