Labeling

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Since existing federal laws already mandate comprehensive disclosure of all clinically relevant ingredients plus extensive post-market oversight, further state and local requirements layered on may afford minimal practical advantages.

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.

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.

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