J & J cuts Tylenol maximum dose to prevent overdoses

TRENTON, n.j., (AP) - Johnson & Johnson said on Thursday that it reduces the daily dose of his extra strength Tylenol painkillers, lower risk of an accidental overdose of paracetamol, its active ingredient, and the top cause of liver failure.

The company's McNeil Consumer Healthcare Division said the change has sold one of the many extra strength Tylenol in the United States - products in short supply in stores due to a string callbacks.

From sometime this fall, labels on extra strength Tylenol packages will now list the maximum daily as six pills or a total of 3,000 mg after below from eight pills a day or 4,000 mg dose. Early next year, McNeil reduces the daily amount for its regular strength Tylenol and other adult pain reliever acetaminophen, the most widely used painkillers in the country with also.

In addition to Tylenol paracetamol painkillers Percocet and vicodin and some non-prescription pain relievers, including NyQuil is the active ingredient in the recipe and some Sudafed products. It is located in thousands of medicinal products, for headaches, fever, sore throat, and chronic pain.

But people who at one time not always recognize several medications paracetamol, which they occupy are how much, in part, because prescription drug labels often it under the symbol "Apap." List

Two years ago required that a consultant food and drug administration panel sweeping restrictions, to prevent accidental fatal overdose of paracetamol which.

Then in January, which said the FDA would the amount of paracetamol in vicodin, Percocet and other prescription painkillers to 325 mg / capsule abundance - just under half of 700 mg up to some products on the market then to. The Agency also said that it worked with pharmacies and others to develop medical standard marking for paracetamol.

"Acetaminophen is safe when used as directed," said Dr. Edwin Kuffner, McNeil of the head of the medical affairs the over-the-counter derivatives, in a statement. "McNeil is their labels for products with acetaminophen (paracetamol) in an attempt, review reduce the likelihood of an accidental overdose."

Excessive use of acetaminophen can cause liver damage. In the United States it is blamed for about 200 fatal overdoses and sends 56,000 people in the emergency room each year.

McNeil spokeswoman Bonnie Jacobs said that other manufacturers of painkillers should similar changes to their product labels.

Extra strength Tylenol is produced at a j & J factory in Las Piedras, Puerto Rico, where production has reduced for months because the FDA concerned about production and quality problems, is additional reviews and require permits before drugs can be delivered. J & j said that the movement of extra strength Tylenol ramp should to in the second half of this year and next year.

Las Piedras one of the three factories involved in most of the 25 Johnson & Johnson recalls since September 2009, with millions of bottles of Tylenol and other non-prescription drugs made by McNeil. Several prescription drugs, implants, hip and contact lenses, made from other j & J subsidiaries also have recalled.

The callbacks for problems with the quality of metal shavings and improper levels of active ingredients in some medicines to packaging with a disgusting smell, led a consent decree between McNeil and FDA this spring.

As a result are Las Piedras and a second factory in Lancaster, PA, examined additional. The third factory manufactured in Fort Washington, PA, children medications such as liquid Tylenol. It is closed since April 2010 and is gutted and completely rebuilt.

Jacobs, said that the label changes not with the callbacks are connected.

Posted in: maximum,overdoses,prevent,Tylenol