From the April 2005 issue

New Children's TYLENOL MELTAWAYS (acetaminophen), for kids aged 2 to 6, quickly dissolve in a child's mouth and make swallowing the medication easy. However, the available blister package exhibits confusing labeling and packaging that could accidentally double the typical dose of medication given to small children. Although intended as a convenience for parents with children who may require one, two, or three tablets per dose, the packaging looks like a typical unit-dose package for institutional use. But while the front of the carton states "medicine per dose 80 mg," the individual blister packs that contain either one or two
80 mg tablets are all labeled "Children's Tylenol 80 mg" (see photo). This situation is especially troubling since the medication is an over-the-counter product. Pediatricians often provide parents with dosing instructions in milligram amounts, not a per tablet dose. With the two-tablet blister packs, some parents (as well as practitioners) may conclude that both tablets should be given to provide an 80 mg dose, resulting in a 160 mg double dose (or a 320 mg dose if 160 mg is intended). McNeil and FDA are aware of this problem, and McNeil is already planning to change the "medicine per dose 80 mg" message on the front label panel to "80 mg per tablet." We've suggested a recall and urged that future blister packaging clearly indicate the exact milligram amount enclosed. Another note of caution: these tablets are formulated to taste like candy and may invite small children to partake on their own. Parents should be provided with enhanced warnings about keeping this product away from children.