Labeling

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The Annual Forecast for Planned Monograph Activities describes planned monograph activities that FDA intends to address over the ensuing three years.

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

Informed Consumer Decision Making

The following information on botanical ingredients should be included in either a bulk botanical raw material specification sheet (for business-to-business transactions) or finished product labeling (when selling directly to consumers).

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.

Learn about rules and regulations for structured product labeling of OTC 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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