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Source: U.S. Food and Drug Administration
Published: June 06, 2005

Several Children�s Tylenol products have been recalled because label information might be confusing and could lead to over-dosing, McNeil Consumer & Specialty Pharmaceuticals said Friday in a statement.

The company, part of Johnson & Johnson, said it was recalling all varieties and all flavors of Children�s Tylenol Meltaways 80-milligram packaged in bottles and blisters, Children�s Tylenol SoftChews 80-milligram in blisters, and Junior Tylenol Meltaways 160-milligram packaged in blisters.

The 80-milligram products are being recalled over concerns that blister packs with two pills in each compartment might suggest to consumers that two tablets provide a total of 80 milligrams of the active ingredient, acetaminophen, when two tablets would actually provide 160 milligrams 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,� McNeil said. �Each tablet is imprinted with the number �80� to reflect this amount.�

The Junior Tylenol Meltaways are being recalled because the labeling information on the carton might be confusing to some consumers in determining proper dosage. Consumers should know that each tablet of Junior TYLENOL Meltaways contains 160 mg of acetaminophen, McNeil said.

Taking more than the recommended dose (overdose) of acetaminophen may cause liver damage when taking the product for fever or pain relief over the course of the three- or five-day period specified by the labeling.

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