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™, 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™, 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®.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of McNEIL-PPC, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; trends toward health care cost containment; and increased scrutiny of the healthcare industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 2, 2011. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither McNEIL-PPC, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
*The third-party trademarks used herein are registered trademarks of their respective owners and not McNEIL-PPC, Inc.