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McNeil Consumer Healthcare Announces Plans for New Dosing Instructions for TYLENOL® Products

Posted on July 28, 2011

Education Campaign Planned to Help Encourage Appropriate Use of Acetaminophen

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(HealthNewsDigest.com) – FORT WASHINGTON, Pa., July 28, 2011 –McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (“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 medications, such as TYLENOL®, SUDAFED® Triple Action(TM), 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.

“Acetaminophen is safe when used as directed,” said Edwin Kuffner, M.D., Vice President of OTC Medical Affairs and Clinical Research at McNeil Consumer Healthcare. “But, when too much is taken (overdose), it can cause liver damage. Some people accidentally exceed the recommended dose when taking multiple products at the same time, often without realizing they contain acetaminophen or by not reading and following the dosing instructions. 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(TM), 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 (www.tylenol.com/getreliefresponsibly).

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.

About McNeil Consumer Healthcare

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.markets a broad range of well-known and trusted OTC products in the United States, including its complete line of TYLENOL(® )(acetaminophen) products. The TYLENOL(®) product line consists of hundreds of products across a variety of adult and pediatric pain categories including: arthritis pain, pain with accompanying sleeplessness and upper respiratory. Other McNeil brands include BENADRYL(® )allergy medicines; IMODIUM(®) A-D anti-diarrheal; MOTRIN(®) IB; ROLAIDS(®) antacid products; SUDAFED(®) and SUDAFED PE(®) nasal decongestants; and ZYRTEC® and ZYRTEC-D®12-HOUR®.

CONSUMER INQUIRIES:
1-877-414-7711

Web Site: http://www.tylenol.com/getreliefresponsibly

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