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Kids' Tylenol Products Recalled Because Of Dosage Concerns

POSTED: Friday, June 3, 2005

The maker of Tylenol said it is recalling some products intended for children, citing concerns about potential confusing information on the correct doses.

The nationwide recall involves the 80 mg. variety of Children's Tylenol Meltaways and Tylenol SoftChews as well as the 160 mg. Junior Tylenol Meltaways. The recall of the pain reliever involves medicine contained in blister packs and bottles.

McNeil Consumer & Speciality Pharmaceuticals said the worry involves concern that that children could get overdoses of the drug. The unit of Johnson & Johnson noted that overdosing the key ingredient, acetaminophen, can result in liver damage.

Concerns have been raised that labeling on the carton and on the back of the two-tablet cavities may erroneously suggest that two tablets provide a total of 80 mg. of acetaminophen, when two tablets would actually provide 160 mg. of the ingredient. Each tablet is imprinted with the number "80" to reflect this amount.

The company said it is working with the Food and Drug Administration on the voluntary recall.

If you have questions or concerns about these products contact McNeil's Consumer Relationship Center at (877) 895-3665 or visit tylenol.com for labeling information. Please send all refund requests in writing to:

McNeil Consumer & Specialty Pharmaceuticals, CRC
7050 Camp Hill Road, MB #790
Fort Washington, PA 19034.

The appropriate children's dosage is shown on the table below:

Children's Tylenol Meltaways
80 milligrams, per one tablet
Child's Weight, Age Dosage
6 to 23 pounds
Newborns to 23 months
Consult your child's doctor
24 to 35 pounds
2 to 3 years
2 tablets
36 to 47 pounds
4 to 5 years
3 tablets
48 to 59 pounds
6 to 8 years
4 tablets
60 to 71 pounds
9 to 10 years
5 tablets
72 to 95 pounds
11 years
6 tablets
More than 96 pounds
12 years and older
Tylenol does not recommend this product

Source: Tylenol.com

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