New labels for Children's Tylenol, Motrin stress safety

FDA Consumer, Jan-Feb, 1998

The manufacturer of Children's

Tylenol (acetaminophen) and Children's

Motrin (ibuprofen) is modifying the labeling

of these over-the-counter analgesics

to ensure their safe and effective

use. Overdoses of Tylenol have been

associated with liver damage and deaths in

children.

McNeil Consumer Products Co., of

Fort Washington, Pa., announced

recently it would:

* Add the warning "Read the instructions

carefully" to the front panel of all

Children's Tylenol dosage forms.

* Change the language to emphasize the

importance of using the specific dosing

device--for example, dropper or cup--that

comes with the product.

* Add the statement "Taking more than

the recommended dose (overdose) will

not provide more pain or fever relief and

could cause serious health risks" to

ensure that parents and other caregivers

understand that there is no advantage to

exceeding recommended doses.

* Change the front panel of Infants'

Tylenol drops to read "Concentrated

Drops" instead of "Suspension Drops."

(For more information on children

and drug dosing, see "How to Give

Medicine to Children" in the

January-February 1996 FDA Consumer.)