USA Recall of Children's TYLENOL(R) Meltaways 80 mg, Children's TYLENOL(R) SoftChews 80 mg & Jr. TYLENOL(R) Meltaways 160 mg

Main Category: Pediatrics / Children's Health
Article Date: 04 Jun 2005 - 11:00 PDT

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McNeil Consumer & Specialty Pharmaceuticals, division of McNeil-PPC, Inc., is voluntarily recalling all lots and all flavors of Children's TYLENOL(R) (acetaminophen) Meltaways 80 mg packaged in bottles and blisters, Children's TYLENOL(R) SoftChews 80 mg packaged in blisters, and Jr. TYLENOL(R) Meltaways 160 mg 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(R) Meltaways 80 mg and Children's TYLENOL(R) SoftChews 80 mg 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 80 mg of the active ingredient, acetaminophen, when two tablets would actually provide 160 mg of acetaminophen. Consumers should know that each tablet of Children's TYLENOL(R) Meltaways and Children's TYLENOL(R) 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(R) Meltaways 80 mg 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(R) Meltaways 80 mg 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(R) 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 Jr. TYLENOL(R) Meltaways 160 mg 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 Jr. TYLENOL(R) 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 Consumer & Specialty Pharmaceuticals 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 Consumer & Specialty Pharmaceuticals' Consumer Relationship Center at 1-877-895-3665 (English) or 1-888-466-8746 (Spanish) or visit TYLENOL.com. The Web site 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 Web site at accessdata.fda.gov/scripts/medwatch.

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