From the June 2005 issue

In late March, we received a report from a pharmacist regarding potentially confusing labeling and packaging of Children's TYLENOL MELTAWAYS (acetaminophen) that could lead to accidental overdoses. We investigated the problem and alerted our subscribers about our findings in the April 2005 issue of this newsletter. The product, for kids aged 2 to 6, comes in blister packs that contain either one or two 80 mg tablets, but the front of the carton indicates "medicine per dose 80 mg," and all of the blister packs are labeled "Children's Tylenol 80 mg." With the two tablet blisters, parents or healthcare practitioners may assume that BOTH tablets should be given to provide the 80 mg, resulting in a dangerous double dose that, if repeated over time, could even cause liver damage.

ISMP promptly followed up with both the FDA and Johnson & Johnson's McNeil Consumer & Specialty Pharmaceuticals division to suggest a recall and urge that future labeling and packaging clearly indicate the exact milligram amount enclosed in each blister. On Friday, June 3, McNeil announced the recall of several Tylenol products for children. Your reports really do make a difference!