Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Pediatric Acetaminophen Panel Debates Execution Of Dosing Changes

This article was originally published in The Pink Sheet Daily

Executive Summary

Both weight-based dosing and the addition of instructions for children younger than 2 years have broad support from manufacturers and health care professionals as well as from FDA advisors.

You may also be interested in...



Potential Pediatric Acetaminophen Label Changes Resurface In Tylenol Class Action Settlement

Settlement could be another milestone in the contentious history of labeling for OTC acetaminophen single-ingredient products generally, and for infant’s and children’s products specifically. Plaintiffs alleged they were misled by J&J to pay more for Infant's Tylenol even though its formulation is the same as Children's Tylenol.

Acetaminophen Dose Labeling, More Sunscreen Information Needed, House Appropriators Tell FDA

Appropriators are "concerned that the lack of dosing information" on OTC drugs for children ages six months to 2 years "may lead to dosing errors, adverse events and inadequate treatment of fever and pain.” They also ask USDA about fraud in its National Organic Program.

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

Johnson & Johnson narrows its pediatric Tylenol tablets a single 160 mg dose and other manufacturers are expected to follow suit, in line with a US FDA panel recommendation.

Related Content

Topics

UsernamePublicRestriction

Register

PS078529

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel