To prevent accidental overdoses that cause liver damage, the manufacturer of Extra Strength Tylenol is telling consumers to limit their daily use to no more than six pills a day.
The new instructions announced by the McNeil Consumer Healthcare unit of Johnson & Johnson cut what had been the maximum dosage of eight pills a day for the painkiller.
The aim is to avoid overdoses of acetaminophen, the product’s active ingredient. The company says it is found in more than 600 over-the-counter and prescription medications and is used by more than 50 million Americans each week, often for headaches, fever, sore throats and chronic pain.
The move follows January’s directive from the Food and Drug Administration to limit the amount of acetaminophen in certain prescription painkillers such as Vicodin and Percocet. Agency officials cited the potential harm to patients who accidentally overdose on the ingredient by taking both prescription and over-the-counter painkillers at the same time.
McNeil told the FDA that its new dosing instructions will appear on Extra Strength Tylenol packages starting this fall, and that next year it will lower maximum daily dosages for Regular Strength Tylenol and other products with acetaminophen. The new maximum daily dosage of Extra Strength Tylenol of six pills equates to 3,000 milligrams of acetaminophen, and is down from the previous daily limit of 4,000 milligrams.
As the Associated Press reports, excessive use of acetaminophen in the U.S. causes about 200 fatal overdoses and sends 56,000 people to emergency rooms.
A company spokeswoman said the maximum dosages changes are not related to a spate of recalls over the past two years involving Tylenol and other Johnson & Johnson products.
STUART SILVERSTEIN
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