Executive Summary

McNeil has changed labeling on Children's TylenolMeltaways blister packs to "80 mg per tablet" from "medicine per dose 80 mg" to prevent consumer confusion, according to the firm. Current individual blister packs containing either one or two 80 mg tablets both state "Children's Tylenol 80 mg," which could lead users to mistakenly assume both tablets are needed for an 80 mg dose, the Institute for Safe Medication Practices states in a recent newsletter. McNeil changed the blister-pack labeling upon learning of the potential confusion, even though no misdosing has occurred since the label's introduction in 2000, the firm notes. FDA deemed a recall unnecessary, but the company is in the process of printing new blister-pack labeling and will begin replacing products promptly, McNeil says...