Children's TYLENOL® Meltaways and SoftChews Recalled, Warning!

McNeil Consumer & Specialty Pharmaceuticals Announces Nationwide Recall of Children's Tylenol Meltaways - 80 Mg, Children's Tylenol Softchews - 80 Mg and Jr. Tylenol Meltaways - 160 Mg

FOR IMMEDIATE RELEASE -- Fort Washington, PA -- June 3, 2005 -- McNeil Consumer & Specialty Pharmaceuticals is voluntarily recalling all lots and all flavors of Children's TYLENOL® Meltaways 80 mg packaged in bottles and blisters, Children's TYLENOL®SoftChews 80mg packaged in blisters, and Junior TYLENOL® Meltaways 160mg packaged in blisters. The blister package design, as well as the information on the blister package and on the blister and bottle cartons may be confusing and could lead to improper dosing, including over-dosing.

Some Children's TYLENOL® Meltaways 80mg and Children's TYLENOL® SoftChews 80mg are packaged in a blister package designed to be convenient for parents who need dosing flexibility depending on the age or weight of the child. The package design includes blister cavities that contain one tablet while other cavities contain two tablets. Concerns have been raised that labeling on the carton and on the back of the two-tablet cavities may erroneously suggest to the consumer that two tablets provide a total of 80mg of the active ingredient, acetaminophen, when two tablets would actually provide 160mg of acetaminophen. Consumers should know that each tablet of Children's TYLENOL Meltaways and Children's TYLENOL SoftChews contains 80 mg of this active ingredient. Each tablet is imprinted with the number "80" to reflect this amount. Caregivers should be guided by the dosage directions in the "Drug Facts" labeling on the carton for the correct number of individual tablets to be given based on the child's age and weight.