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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

McNeil Consumer & Specialty Pharmaceuticals Announces Nationwide Recall of Children's Tylenol Meltaways - 80 Mg, Children's Tylenol Softchews - 80 Mg and Jr. Tylenol Meltaways - 160 Mg

Contact:
Kathy Fallon, 215-273-7818
Bonnie Jacobs, 215-273-8994

FOR IMMEDIATE RELEASE -- Fort Washington, PA -- June 3, 2005 -- McNeil Consumer & Specialty Pharmaceuticals is voluntarily recalling all lots and all flavors of Children's TYLENOL Meltaways 80 mg packaged in bottles and blisters, Children's TYLENOLSoftChews 80mg packaged in blisters, and Junior TYLENOL Meltaways 160mg packaged in blisters. 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.

Some Children's TYLENOL Meltaways 80mg and Children's TYLENOL SoftChews 80mg are packaged in a blister package designed to be convenient for parents who need dosing flexibility depending on the age or weight of the child. The package design includes blister cavities that contain one tablet while other cavities contain two tablets. Concerns have been raised that labeling on the carton and on the back of the two-tablet cavities may erroneously suggest to the consumer that two tablets provide a total of 80mg of the active ingredient, acetaminophen, when two tablets would actually provide 160mg 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. Each tablet is imprinted with the number "80" to reflect this amount. Caregivers should be guided by the dosage directions in the "Drug Facts" labeling on the carton for the correct number of individual tablets to be given based on the child's age and weight.

In addition, some Children's TYLENOL® Meltaways 80mg are packaged in a bottle. The bottle is packaged in a carton. Concerns have been raised that the information on the front panel of the carton for Children's TYLENOL Meltaways 80mg may be confusing to some consumers in determining the proper dosage. The carton labeling says that each dose provides 80 mg of acetaminophen. Consumers should know that each tablet of Children's TYLENOL Meltaways contains 80 mg of acetaminophen. Caregivers should be guided by the dosage directions on the bottle label for the correct number of individual tablets to be given based on the child's age and weight.

Concerns have also been raised that the carton labeling for Junior TYLENOL Meltaways 160mg may be confusing to some consumers in determining the proper dosage. This labeling says that each dose provides 160 mg of acetaminophen. Consumers should know that each tablet of Junior TYLENOL Meltaways contains 160 mg of acetaminophen. Caregivers should be guided by the dosage directions in the "Drug Facts" labeling on the carton for the correct number of individual tablets to be given based on the child's age and weight.

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.

McNeil is working with the U.S. Food and Drug Administration in this recall and in the effort to alert consumers and retailers nationwide about this issue. Consumers or retailers who have questions or concerns about a product described in this alert should contact McNeil's Consumer Relationship Center at 1-877-895-3665 (English) or 1-888-466-8746 (Spanish) or visit www.TYLENOL.com. The website contains written material and photos of the product and the packaging. Any adverse reactions experienced with the use of these products should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at https://www.accessdata.fda.gov/scripts/medwatch/

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