Tylenol Latest Big Brand to Come Under FDA Scrutiny

Panel Seeks to Limit Acetaminophen in OTC Medication; Drug Is Used in Many Marketers’ Products

By

Rich Thomaselli

Published: July 01, 2009

NEW YORK (AdAge.com) — First, the Food and Drug Administration went after Cheerios. Now it appears to be targeting another beloved U.S. brand: Tylenol.

The FDA advisory panel recommendation could present advertising problems for J&J and Tylenol, as well as the rest of the big players in the pain-relief industry. 

An FDA advisory panel has recommended that the regulatory agency reduce the maximum dosage of acetaminophen, the main ingredient in over-the-counter pain relievers such as Johnson & Johnson’s Tylenol and Novartis’ Excedrin, to 325 milligrams a pill from 500 milligrams a pill, and to fewer than 4,000 total milligrams a day. It’s also recommending that the single 1,000-mg dose be available only by prescription. The same panel earlier had recommended pulling two prescription medications that contain acetaminophen, Percocet and Vicodin, off the market.