CHPA Q&A: Update on OTC Children's Pain Relievers and Fever Reducers
Understand how CHPA’s member companies are working to replenish supply quickly by directing products where they are needed most. This document also includes information about where parents can find these medicines and additional self-care options to aid in comfort and relief.
The members of the stakeholder selection committee respectfully submit these candidates to serve as the non-voting industry representative and alternate (as needed) for the FDA Pediatric Advisory Committee.
CHPA requests that FDA publish a statement of enforcement policy expressly permitting manufacturers of single-ingredient acetaminophen OTC drugs subject to the ongoing internal analgesic, antipyretic, and antirheumatic monograph proceedings to including labeling on products that provide instructions for use in children aged six months to two years.
CHPA comments on the “Notice of Availability of Draft Guidance Regarding Which Children’s Products are Subject to the Requirements of CPSIA Section 108.”
Under a voluntary program which began in November 2007, manufacturers of OTC oral pediatric cough and cold medicines should take the following steps in the labeling, packaging, and promotion of these medicines.
This Proposed Safety Administrative Order addresses the GRASE status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients.
Understand how CHPA’s member companies are working to replenish supply quickly by directing products where they are needed most. This document also includes information about where parents can find these medicines and additional self-care options to aid in comfort and relief.
As a direct result of the PROTECT initiative, CHPA developed a voluntary guideline for industry suggesting ways to standardize volumetric measures in dosing directions and dosing devices for oral pediatric liquid drug products.
