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 CHPA Educational Foundation today released findings from a study examining the common attitudes and behaviors of parents when administering pediatric over-the-counter (OTC) liquid medicines to young children.
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CHPA comments on the “Notice of Availability of Draft Guidance Regarding Which Children’s Products are Subject to the Requirements of CPSIA Section 108.”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.
FDA Announcement of a proposed safety-based Administrative Order (AO) to address dosage strengths of oral, single ingredient, pediatric acetaminophen products. This AO proposal includes the addition of weight and age-based dosing for children under age 12.
Lawmakers should support the centralized progress made on ingredient evaluation, labeling, and packaging protections by specialized national children’s health agencies instead of allowing jurisdiction confusion that ultimately hinders healthcare advancement for all ages.
