Labeling

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CHPA supports efforts to reduce medication errors, including those that encompass errors in information acquisition by the consumer, who is the principal end user of self care products, and by health professionals as well.

Jul 26, 2002

Request for agency exercise of enforcement discretion regarding the addition of new Warning language to Drug Facts labeling for Over-the-Counter benzocaine liquid/gel products indicated for relieving oral discomfort.

Oct 12, 1012

Product Safety & Integrity

CHPA members agree voluntarily to market products containing kava with the following dosage and labeling.

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.

FDA Announcement of a proposed safety-based Administrative Order that proposes to add a skin allergy warning to labeling requirements for acetaminophen-containing drug products.

FDA Announcement of a proposed safety-based Administrative Order to update the pregnancy warning labeling for NSAID-containing drug products.

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