Labeling for Some Acetaminophen Products To Change
McNeil Consumer Healthcare on July 28 announced changes to maximum daily dose recommendations in the labeling for Extra Strength Tylenol.
Starting this fall, the labeling for the nonprescription analgesic will recommend that patients take no more than six 500-mg tablets or capsules per day, for a total maximum daily dose of 3000 mg of acetaminophen.
Current labeling for the product instructs consumers to take no more than eight tablets or capsules, or 4000 mg of acetaminophen, per day.
The dosing interval has also been changed to state that patients should take the medication every six hours, not every 4–6 hours, as previously recommended.
The labeling changes are intended to decrease the risk for liver toxicity in patients who use acetaminophen, according to McNeil.
Also on July 28, Cadence Pharmaceuticals announced that no changes have been made to the labeling for the company's i.v. acetaminophen product, Ofirmev injection.
According to the company, the FDA-approved dosage of Ofirmev is 4000 mg/day for adults and adolescents weighing at least 50 kg, as described in the product's labeling (PDF).
Ofirmev is available only by prescription.