For more than 35 years, Johnson & Johnson has jousted with the FDA over warnings for Tylenol, the ubiquitous over-the-counter pain reliever that is a huge-selling, franchise brand used by millions of people every year, but which has also been the focus of a long-running controversy concerning the safety of its medicine and consumer perception. Specifically, the healthcare giant and the agency have tussled over scientific links to cases of death and severe liver damage; the amount of Tylenol that can be taken safely each day without causing an overdose; a separate warning about mixing acetaminophen, the active ingredient, with alcohol; and an FDA campaign designed to raise public awareness of taking too much of the medicine.
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