Pediatrics Medicine

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CHPA comments on the “Notice of Availability of Draft Guidance Regarding Which Children’s Products are Subject to the Requirements of CPSIA Section 108.”

Mar 24, 2009

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.

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 OTC oral health care drug products containing benzocaine alone or with phenol preparations labeled for anesthetic/analgesic indications (21 CFR 356).

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.

The CHPA Educational Foundation is dedicated to helping consumers lead happier, healthier lives by providing information and guidance on how to safely use, store, and dispose of OTC medicines, dietary supplements, and consumer medical devices.

This Proposed Safety Administrative Order addresses the GRASE status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients.

The foundation’s consumer-facing and mobile-friendly website, KnowYourOTCs.org, provides consumers with easily accessible information and guidance on how to safely use, store, and dispose of OTC products.

The Treat with Care campaign provides parents and caregivers of young children with the information they need to safely use pediatric OTC cough and cold medicines.

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