Consequently, a unilateral decision on July 28,
2011, was made by McNeil, the manufacturer of
the Tylenol brand of acetaminophen, to modify
the current label and dosage regimen (which is
permitted under the monograph process) of its
500 mg/tablet product, for patients who are not
under the care of a health care professional, to
six doses (3000 mg) daily. This decision was not
mandated by the FDA, and generic acetaminophen
manufacturers did not follow suit. Ironically, the
recommended doses of the Tylenol brand 325 mg
tablets and 650 mg sustained-release products
remain the same. For both products, McNeil’s
recommendations continue to allow a maximum
daily dose of 3900 mg. While McNeil has announced
plans to modify the doses of the 325 mg
strength in 2012, it is not obligated to do so, and
its unilateral action does not obligate any other
manufacturers to modify their dosing regimens,