Tylenol First To Move On Single Dosage For Children’s Acetaminophen

Johnson & Johnson narrows its pediatric Tylenol tablet line to a 160mg dose, in line with an FDA advisory panel’s recommendation and likely with other children’s acetaminophen product manufacturers to follow.

Solid-dose pediatric Tylenol products will be available only as 160mg scored chewable tablets branded Children’s Tylenol Chewables with dosing instructions for children 2 to 11 years of age, said a J&J spokesperson in a March 7 email.

According to an entry updated Jan. 17 in the National Library of Medicine’s online database of drugs marketed in the US, front-of-package labeling for Children’s Tylenol Chewables packages includes the statement “New Strength & Directions.” The product is available in grape and bubblegum flavors.

J&J previously marketed Tylenol tablets in two dosages indicated for pediatric use: 80mg Children’s Tylenol for children ages 2 to 11 and 160mg “Jr Tylenol” for children 6 to 11. The American Pharmacists Association reported recently that J&J sent letters advising pharmacists to counsel consumers on the change and that some of the 80mg dosage may remain available in stores and online.

Front-of-package labeling for Children’s Tylenol Chewables (160mg), which J&J recently made its single pediatric Tylenol dose, includes the statement “New Strength & Directions.”

National Institutes of Health’s NLM

The Consumer Healthcare Products Association says other manufacturers of children’s acetaminophen tablets and other solid oral formats already are changing the dosage to 160mg.

The change stems from an FDA joint advisory panel recommendation in 2011 to move all solid single-ingredient oral children’s acetaminophen products to a single strength. The panel maintained the more options available, the higher the risk for dosing errors. (Also see "Acetaminophen Panel Recommends Standardizing Solid Dose Strength" - Pink Sheet, 23 May, 2011.)

“Manufacturers are moving toward single dosage, but the timeline is different for each and the goal is to avoid any possible kind of consumer confusion,” said CHPA Senior VP Communications & Regulatory Affairs Anita Brikman.

Other children’s acetaminophen products include Prestige Brands Holdings Inc.’sLittle Remedies line and private label or store brand versions made by Perrigo Co. PLC and other manufacturers.

At the 2011 FDA advisory panel, J&J executives argued that a single-strength children’s chewable was not warranted because the firm received few calls on clarification of the 80mg and 160mg sizes. They said if the drug were available in an 80mg dose only, older children would need to take six tablets for an adequate dose, which would not be a good dosing behavior for children. Conversely, a larger dose would require consumers to split tablets to administer a smaller dose if needed.

The company moved forward on the recommendation anyway, following a similar approach it and other manufacturers used for liquid acetaminophen products. FDA recommended in a 2014 draft guidance that to reduce confusion over multiple pediatric formulations of acetaminophen-containing products with varying concentrations, all pediatric single-ingredient acetaminophen liquids should have a concentration of 160mg of the ingredient per 5mL. (Also see "Draft Pediatric Acetaminophen Guidance Drills Down With Details To Cut Overdose Risk" - Pink Sheet, 15 Oct, 2014.)

At that time, CHPA noted that manufacturers in 2011 standardized the concentration of OTC liquid acetaminophen products to 160mg/5mL formulations and all other concentrations had been phased out.

The 2011 FDA advisory panel also recommended weight-based dosing for children’s acetaminophen products, rather than the age-based dosing used at that time; that change has been universally implemented to products. (Also see "Pediatric Acetaminophen Panel Debates Execution Of Dosing Changes" - Pink Sheet, 25 May, 2011.)

From the editors of The Tan Sheet.