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Mcneil Consumer Health December 19, 2011

IMPORTANT NEWS:

New Dosing Instructions for
Extra Strength TYLENOL® Products

Today, more than 600 over-the-counter (OTC) and prescription (Rx) medications contain acetaminophen. Some patients accidentally exceed the recommended dose when taking multiple acetaminophen-containing products at the same time, often without realizing they contain acetaminophen or by not reading and following the dosing instructions.

McNeil Consumer Healthcare (McNeil), the makers of TYLENOL® is leading the industry in implementing new steps designed to lessen the possibility of accidental acetaminophen overdose and help ensure that people who use TYLENOL®, and other products containing acetaminophen, use them appropriately.

As one step toward that goal, McNeil is voluntarily introducing new dosing instructions for single-ingredient Extra Strength TYLENOL® sold in the United States.

The revised dosing instructions on the OTC label for Extra Strength TYLENOL® reflect the following changes:

• Take 2 caplets (1,000 mg) every 6 hours while symptoms last
(revised from 2 caplets every 4 to 6 hours).
  • Not to take more than 6 caplets (3,000 mg) in 24 hours, unless directed by a doctor
(revised from 8 caplets in 24 hours).
  • The Warnings section will be modified to reflect the new daily dose.
  Specifically, the liver warning on the OTC label will continue to state that severe liver damage may occur if more than 4,000 mg of acetaminophen is taken.
Revised Directions

For patients whose pain or fever recurs despite the administration of a total daily dose of 3,000 mg, the new dosing instructions allow for healthcare professionals to exercise their discretion.

Please see TylenolProfessional.com for Frequently Asked Questions that include information about dosing changes for Regular Strength TYLENOL® and multi-ingredient/upper respiratory TYLENOL® products as well. If you have any questions, call our Medical Affairs Department at 1-866-948-6883, Monday through Friday, 9:00 am to 4:30 pm ET.


Mcneil Consumer Health
7050 Camp Hill Road
Fort Washington, PA 19034, USA

©McNEIL-PPC, Inc. 2011