Important update – Pediatric solid dose change

Many manufacturers and retailers of pediatric acetaminophen solid dose medicines including Johnson & Johnson Consumer Inc., the makers of Children’s TYLENOL®, are transitioning to a single strength of 160 mg chewables in the United States.

This transition is consistent with a 2011 FDA Advisory Committee recommendation that the FDA consider a single strength for solid pediatric acetaminophen products. It is intended to help minimize the potential for medication errors due to confusion between multiple strengths.

Important points related to this topic for you to be aware of:

  • Currently the marketplace includes pediatric acetaminophen chewable products available in both 80 mg and 160 mg strengths. These are commonly referred to as “Children’s” and “Jr” respectively.

  • Many manufacturers and retailers will be transitioning to one 160 mg strength to be named “Children’s”. This dosage strength aligns with the most common single ingredient pediatric liquid acetaminophen medicine concentration (160 mg/5mL).

  • As manufacturers and retailers make this transition, there will still be some solid dose chewable products labeled as “Children’s” available in the marketplace and in medicine cabinets at the 80 mg strength as well as product labeled as “Junior” at the 160 mg strength.

  • The pediatric acetaminophen products currently on the market can continue to be used as labeled.

  • The in-store transition to the single strength 160 mg acetaminophen chewable products will begin in early 2017 and is anticipated to continue throughout 2017. However, the transition within any caregivers’ medicine cabinet may take considerably longer.

What you can do to help your patients:

  • Always verify the product strength a parent or caregiver is using before providing dosing directions.

  • Remind caregivers to always read and follow the Drug Facts label dosing directions of the specific medication that they are using.

Tools to help you communicate these important messages to your HCP networks:

Resources to guide your communications