Children’s TYLENOL® Chewables

Simplifying the Children’s TYLENOL® dosage for caregivers

1. Why are you making this change to the Children’s TYLENOL® dose?

This transition is consistent with a 2011 FDA Advisory Committee recommendation that the FDA consider a single strength for solid pediatric acetaminophen products. The decision to only offer the 160 mg strength was based upon a number of factors: 1) The 160 mg is currently the most widely used solid oral dosage form; 2) this dosage strength aligns with the most common single ingredient pediatric liquid acetaminophen medicine concentration (160 mg/5mL); and 3) the need to take fewer tablets per dose is likely to improve dosing compliance, especially for older children, who are more likely to use the solid dosage forms.

2. Why are you making this change now?

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division is eager to simplify dosing and has taken the time needed to gain support from several key professional and retail organizations to make this change in 2017.

3. Is it still safe to use the 80 mg product?

Please always read and follow the label. Check the expiration date on the bottle. Unexpired product is safe to use according to the label instructions. Any medication that is beyond its expiration date should be discarded.

4. What is the dosing for this 160 mg Chewable TYLENOL®?

The 160 mg Children’s TYLENOL® Chewables provides age and weight-based dosing for children ages 2 through 11 years. Please always read and follow the label.

5. Is there a difference between the Children’s TYLENOL® Liquid and Children’s TYLENOL® Chewables?

Children’s TYLENOL® Suspension (Liquid) and Children’s TYLENOL® Chewables differ by dosage form and by available flavors. Both products are safe and effective for use in children ages 2-11 years when used as directed and provide the same doses of acetaminophen when used according to the label.

6. Are other manufacturers making the same change, and if so, when will they transition?

Each individual manufacturer ultimately has to decide on its own on whether to make the change to manufacture only the 160 mg strength pediatric acetaminophen product.

7. Will this be the same in both the US and Canada?

Children’s TYLENOL® solid oral dose acetaminophen is already offered only as a 160 mg strength in Canada. Johnson & Johnson Consumer Inc. will be marketing all 160 mg pediatric dosage forms (including the Oral Suspension) as Children’s TYLENOL®.

8. How do I recommend dosing if I don’t know what product the caregiver/parent has or will purchase?

Please always verify the acetaminophen dosage strength (80 mg or 160 mg) a parent is using before providing dosing directions. Always remind caregivers/parents to read and follow the label dosing information and to always keep the tablets in the original container. Children’s TYLENOL® Chewables are only available as 160 mg.

9. How easy is it to break the product to give my child the appropriate dose?

The Children’s TYLENOL® Chewables Grape and Bubblegum products both have a score, or a “break” line, to indicate the ½ tablet for dosing. Breaking the product in half to achieve the appropriate dose can be done using that score line. Some consumers may use a pill splitter to divide the tablet cleanly along the score line, but Children’s TYLENOL® Chewables should break along the score line just using your fingers.

10. Isn’t 160 mg a stronger dose of acetaminophen meant specifically for older Children? I thought that Jr TYLENOL® was for ages 6 to 11 years?

Beginning February 2017, all solid-dose pediatric TYLENOL® products are available only as 160 mg scored chewable tablets named Children’s TYLENOL® Chewables, with dosing instructions from 2-11 years of age. This transition will provide a consistent product strength across the Children’s TYLENOL® line. In the past, 80 mg acetaminophen chewable tablets for children ages 2-11 years were available under the name Children's TYLENOL® MELTAWAYS® and 160 mg chewable tablets for children ages 6-11 years were available under the name named Jr TYLENOL® MELTAWAYS®.