McNeil Consumer Healthcare ("McNeil") today announced plans for new dosing instructions lowering the
maximum daily dose for single-ingredient Extra Strength TYLENOL® (acetaminophen) products sold in the U.S.
from 8 pills per day (4,000 mg) to 6 pills per day (3,000 mg). The change is designed to help encourage
appropriate acetaminophen use and reduce the risk of accidental overdose. Acetaminophen, the active
ingredient in TYLENOL®, can be found in more than 600 over-the-counter (OTC) and prescription
, such as TYLENOL®, SUDAFED® Triple Action™, NyQuil®, Percocet® and Vicodin®.*
Acetaminophen is used by more than 50 million Americans each week to treat conditions such as pain, fever
and aches and pains associated with cold and flu symptoms.
McNeil is revising its labels for products containing acetaminophen in an attempt to decrease the likelihood of
accidental overdosing in those instances.”
McNeil has informed the U.S. Food and Drug Administration (FDA) that the new dosing instructions will appear
on Extra Strength TYLENOL® product packages in the U.S. beginning in the fall of 2011. McNeil will also be
lowering the maximum daily dose for Regular Strength TYLENOL® and other adult acetaminophen-containing
products beginning in 2012. Consumers can continue to use their TYLENOL® and other adult acetaminophen-
containing products as currently labeled. The company is working closely with other manufacturers of
acetaminophen products to help ensure consistency in dosing instructions.
In addition to the new dosing instructions on the OTC label, the makers of TYLENOL® recently launched Get
Relief Responsibly™, a national initiative designed to educate consumers about the appropriate use of
prescription and OTC medications, particularly those containing acetaminophen, and the importance of reading
and following medication labels. As a part of this initiative, the TYLENOL® website has been enhanced to
include interactive tools to help consumers identify products that contain acetaminophen. Click Here
McNeil also announced that it will be introducing Bottle Cap Messaging on select Extra Strength TYLENOL®
products. The Bottle Cap Messaging is a message printed directly on bottle caps to remind consumers to
always read and follow the label instructions. This messaging is planned to appear on select Extra Strength
TYLENOL® caps starting in 2012.