Important Update on Dosing and Concentration Changes for OTC Infants' Acetaminophen

June 21, 2011

Dear Healthcare Professional:

I am writing to inform you of an important industry-wide transition to a single concentration of 160mg/5mL for all OTC pediatric single-ingredient liquid acetaminophen products. With this change in single concentration to 160mg/5mL for infants' acetaminophen product, there will be new dosing directions. The infants’ acetaminophen products now will be the same concentration as the children’s acetaminophen products. This transition is consistent with an FDA Advisory Committee recommendation made in 2009.

Infants’ acetaminophen products with this new concentration are beginning to appear on store shelves now. It is important to be aware that there may be a time period when both the old and new concentrations of infants’ acetaminophen products are available in stores and in medicine cabinets. The pediatric acetaminophen products currently on the market can continue to be used as labeled.

We ask for your support in proactively discussing this change with parents and caregivers at sick and well visits. It is important that you and your staff always verify the product concentration parents and caregivers are using before providing dosing directions. As you know, the package label for infants’ acetaminophen advises parents and caregivers of children less than 2 years of age to consult a healthcare professional for dosing information. To that end, the following materials are available to download on www.tylenolprofessional.com:

• A frequently asked questions sheet for you and your staff
• Patient information sheet to assist you in providing correct infants’ acetaminophen dosing information to parents

While Infants’ TYLENOL® is not currently on store shelves, we are providing this information to help ensure you have the resources needed during this industry-wide transition. Infants’ TYLENOL® will be available for consumers as early as this upcoming cold and flu season.

To request a new infants’ acetaminophen dosing chart and other in-office materials, go to www.tylenolprofessional.com. For all other questions, please call our Consumer Care Center at 1-888-892-6100, Monday through Friday, 8:00 am to 8:00 pm ET. If you have any questions about the industry-wide transition, please visit CHPA at www.chpa-info.org/pressroom/05_05_11_PedAceConv.aspx. We greatly appreciate your continued support.

Sincerely,