Important: Transition to Single Concentration — Pediatric Liquid Acetaminophen Products

May 4, 2011

Dear Healthcare Professional:

I would like to inform you about an industry-wide transition to a single concentration of 160mg/5mL for all single-ingredient OTC pediatric liquid acetaminophen products. McNeil Consumer Healthcare will transition the concentration of Infants’ Concentrated TYLENOL® Drops (80mg/0.8mL = 100mg/mL) to the same concentration as Children’s TYLENOL® Suspension (160mg/5mL = 32mg/mL). The purpose of this transition is to help minimize the potential for medication errors due to confusion between infants’ and children’s acetaminophen products having different concentrations. This upcoming transition is consistent with an FDA Advisory Committee recommendation in 2009.

Although Infants’ TYLENOL® will not be available for your patients until the upcoming cold and flu season, we want to proactively inform you about this industry-wide transition. The following are some important points related to this topic for you to be aware of at this time:
  • As announced by the OTC trade organization, Consumer Healthcare Products Association (CHPA), other manufacturers also intend to transition to the same single concentration (160 mg/5mL) for all single-ingredient OTC pediatric liquid acetaminophen products. This transition of other manufacturers’ infants’ products to the children’s product concentration may begin as early as this summer and is anticipated to continue into 2012.
  • The pediatric acetaminophen products currently on the market can continue to be used as labeled.
  • With this change to a single concentration of 160mg/5mL, there will be new dosing directions for the infants’ acetaminophen products. The infants’ products will include a dosing device (e.g. syringe) appropriate for infants.
  • It is important to be aware that there may be a time period when both the current and new concentrations of infants’ acetaminophen products are available in stores and in medicine cabinets. We ask your support in proactively discussing this change with parents and caregivers and ask that you and your staff always verify what product concentration parents and caregivers are using before providing dosing directions.

Although Infants’ TYLENOL® is not currently available, McNeil is committed to supporting parents, caregivers, you and your staff through this important transition. We will be in touch with you over the coming months as this industry-wide transition is implemented.

Please always verify the product concentration a parent or caregiver is using before providing dosing directions.

If you have any questions pertaining to Infants’ and Children’s TYLENOL®, please call our Healthcare Professional line at 1-866-948-6883, Monday through Friday, 9:00 am to 4:30 pm ET. If you have questions about the industry-wide transition, please contact CHPA at
www.chpa-info.org/pressroom/05_05_11_PedAceConv.aspx. We greatly appreciate your continued support.

Sincerely,

Edwin K. Kuffner Signature
Edwin K. Kuffner, MD
Vice President, OTC Medical Affairs & Clinical Research
McNeil Consumer Healthcare, Division of McNeil-PPC, Inc.