Posted on 06/04/2005 10:25:24 AM PDT by new cruelty
June 3, 2005 -- The maker of Tylenol has issued a voluntary recall for three of its products:
- Children's Tylenol Meltaways (80 milligrams)
- Children's Tylenol SoftChews (80 milligrams)
- Jr. Tylenol Meltaways
All lots and flavors of those items packaged in bottles and blisters are included in the recall. However, no liquid versions of those products are involved, says Kathy Fallon, director of communications for McNeil Consumer & Specialty Pharmaceuticals.
The recall stems from design and labeling issues, Fallon tells WebMD. "There is nothing wrong with the product.
"Some users may become confused by the 'blister' package design and by some copy on the front label," says Fallon. She says consumers should "always refer to the drug facts label or the label on the bottle."
Design Issues
"The blister package design, as well as information on the blister package and on the blister and bottle cartons, may be confusing and could lead to improper dosing, including overdosing," says a McNeil news release.
"Blister" packages are intended to be convenient for parents who need dosing flexibility depending on the child's weight or age, says the release. Some blister "cavities" include one tablet, while others contain two tablets.
Each children's Tylenol Meltaway and children's Tylenol SoftChew tablet contains 80 milligrams of the active ingredient, acetaminophen. However, McNeil says concerns have been raised that some people may mistakenly think that the two-tablet blister may total 80 milligrams of acetaminophen. Actually, two tablets would add up to 160 milligrams.
Some Children's Tylenol Meltaways come in bottles packaged in cartons. Some information on carton fronts may also confuse consumers about proper dosage, says McNeil.
Cartons for Junior Tylenol Meltaways may also be confusing. Consumers should know that each tablet of junior Tylenol Meltaways contains 160 milligrams acetaminophen.
Overdose Hazard
An overdose of acetaminophen may cause liver damage when the product is taken to relieve fever or pain over the course of the three- or five-day period specified by the labeling, says McNeil.
The company says it's working with the FDA on the recall and asks consumers to direct questions to its consumer relationship center at (877) 895-3665 (in English) or (888) 466-8746 (in Spanish).
I knew these would be problematic, they look, taste, and are packaged, like candy.
What's so great about Tylenol anyway? The effective dose isn't that much lower than the lethal dose.
The juniors are packaged one to a blister and states on the back of each blister that it contains 160 mg. Don't see the packaging problem there. I have two pks of them but really prefer the liquid as children don't need to do meltaways when they really feel sick and feverish.
Medicine ping
Well, I think it's less dangerous than aspirin or ibeprofin (spelling? nah), which can cause allergic reactions.
The problem isn't with the product. The problem is with stupid people who can't read the labels to figure out how much to give their kids. The company is so lawsuit skittish that they're burning a few million dollars in publicity and lost product to issue a recall for something that, 10-20 years ago, no one would have cared about. Sad thing is, this recall probably will cost them less in the long run than a bogus class-action lawsuit.
It's the AP version that the NY Times posted. I don't like to post AP articles unless it's very interesting. The usually don't have a byline, and it seems that whoever wrote it took English as a second language. Besides that, they are slanted too often.
FReepmail me if you want on or off my health and science ping list.
Aspirin doesn't destroy your liver the way acetomenifen does. Johnson and Johnson have rightly gotten sued in the past due to information they left off their labels. They have put in sheets that had incorrect dosages listed, and they have failed to mention that alcohol will decreases the lethal dose.
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