HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

OTC Pediatric Acetaminophen Guidance More Flexible By Omission

This article was originally published in The Tan Sheet

Executive Summary

The guidance largely tracks a 2014 draft guidance but omits statements on discouraging use of droppers as dosing devices and changes some language to clarify where firms have some leeway in stating label information.

You may also be interested in...



Children's Single-Use Cough/Cold Vials Recalled Due To Potential Contamination

Recent recalls added to FDA database also include more than 25,000 bottles of Harmless Harvest yogurt drinks due to possible packaging defect that may cause premature spoilage; nearly 37,000 containers of Barlean's dietary supplements due to undeclared sulfites. Separately, B. cepacian and related bacteria strains linked to potential contamination of Village Company's  recall of 2,377 cases of La Bella Extreme Sport Styling Gel.

Draft Guidance Drills Down With Details To Cut Pediatric Acetaminophen Overdose Risk

FDA suggests new and repeats previous recommendations to reduce the risk of pediatric overdose with acetaminophen products due either to unsupervised ingestion or therapeutic errors. The guidance includes greater detail on delivery devices and labeling information for pediatric acetaminophen OTCs.

Beauty Packaging Producers: July Marks Registration Deadline With PRO In Three States

Companies considered producers of single-use packaging in Oregon, Colorado and California must register with Circular Action Alliance, the leading (and currently only) producer responsibility organization, by 1 July 2024 under new state recycling laws.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS123571

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