June 6, 2005
McNeil Consumer & Specialty Pharmaceuticals has recalled Children's Tylenol Meltaways 80 mg (packaged in bottles and blisters), Children's Tylenol Softchews 80 mg (packaged in blisters), and Junior Tylenol Meltaways 160 mg (packaged in blisters). All flavors are included in the recall. 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. The active ingredient in the recalled Children's Tylenol products is acetaminophen, too much of which can cause liver damage. For more information, including an image of the product, visit www.tylenol.com. If your child has experienced a reaction to this product, report the incident to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
