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FORT WASHINGTON, Pa. (AP) -- The maker of Tylenol said Friday it is voluntarily recalling several children's products because label information may be confusing and could lead to overdosing.
McNeil Consumer & Specialty Pharmaceuticals said it is recalling all lots and all flavors of 80-milligram Children's Tylenol Meltaways packaged in bottles and blisters, 80-milligram Children's Tylenol SoftChews packaged in blisters, and 160-milligram Jr. Tylenol Meltaways packaged in blisters. The recall affects only SoftChews and Meltaways versions of the product. McNeil is a unit of health care products company Johnson & Johnson Inc.,
In 80-milligram products, the recall was triggered by concerns that blister packs containing two pills in each compartment would lead some consumers to believe that the two tablets contained a total of 80 milligrams of acetaminophen; each tablet contains 80 milligrams.
The company eliminated the double-pill blister cavity design for a single pill cavity design in the first quarter, McNeil spokeswoman Kathy Fallon said.
As for bottled products and the 160-milligram product, the company said that labeling on the front panel of the carton could confuse consumers on proper dosages. The spokeswoman said McNeil was changing wording on the front of the package to say that each "tablet" contains the given strength of acetaminophen rather than each "dose."
In all cases, caregivers should follow the dosage directions in the medications' "Drug Facts" label or on the bottle label, Fallon said.
Fallon said the company was alerted to the possible confusion after receiving calls from consumers concerning proper dosing. She said she didn't know how many units were affected by the recall, or how long it would take to complete. She said the company had no reports of adverse events related to dosing.
The company is not asking for returns, because nothing is wrong with the medication itself, Fallon said. McNeil is launching a campaign to alert consumers about proper dosages.
The company said it notified the Food and Drug Administration of the voluntary recall.
Shares of Johnson & Johnson fell 46 cents, or 0.7 percent, to $66.54 in afternoon trading on the New York Stock Exchange.
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Consumers or retailers who have questions can call McNeil at (877) 895-3665. Those wishing to speak to someone in Spanish can call (888) 466-8746. The company's Web site -- http://www.tylenol.com -- has photos of the product and the packaging.
(Copyright 2005 by The Associated Press. All Rights Reserved.)
