IMPORTANT: Plans for New Dosing Instructions for TYLENOL® Products

July 28, 2011

Dear Healthcare Professional:

Today more than 600 over-the-counter (OTC) and prescription (Rx) medications contain acetaminophen. Some patients exceed the recommended dose either by accidentally taking multiple acetaminophen-containing products without realizing it, or by not following 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 to 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 new dosing instructions will appear on Extra Strength TYLENOL® product packages beginning in the fall of 2011. The revised dosing instructions on the OTC label for Extra Strength TYLENOL® will advise patients to:

• take 2 caplets (1,000 mg) every 6 hours while symptoms last
  (as opposed to 2 caplets every 4-6 hours)
• not take more than 6 caplets (3,000 mg) in 24 hours, unless directed by a doctor
  (as opposed to 8 caplets in 24 hours)

For patients whose pain or fever recurs despite the administration of a total daily dose of 3,000 mg, as noted above, the new dosing instructions allow for healthcare professionals to exercise their discretion. 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. The warnings section will be modified to reflect the new daily dose.

McNeil Consumer Healthcare will also be lowering the maximum daily dose for Regular Strength TYLENOL® and other adult acetaminophen-containing products beginning in 2012. Patients 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.

We ask for your help in reminding patients to never take more than one acetaminophen-containing medication at the same time, not to exceed the recommended dose and to always read and follow the label. To assist you, McNeil has recently launched GET RELIEF RESPONSIBLY™, a national initiative designed to educate patients about the appropriate use of prescription and OTC medications, particularly those containing acetaminophen. Patient education resources can be ordered at TylenolProfessional.com. We will be reaching back out to you in the fall as Extra Strength TYLENOL® product packages with the new dosing instructions begin to appear on store shelves to provide you with additional patient education resources and support.

If you have any questions, please call our Medical Affairs Department at 1-866-948-6883 (available Monday-Friday 9:00 a.m. to 4:30 p.m. Eastern Time).

Sincerely,