To address the growing need for more information on dietary supplements available in the market, the Office of Dietary Supplements at the National Institutes of Health has developed the Dietary Supplement Label Database. This valuable resource compiles comprehensive information obtained from the labels of dietary supplement products sold in the United States.
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.
CHPA is the home for responsible members of the consumer healthcare community. We represent leading manufacturers, and the companies that service them, in the area of OTC medicines, dietary supplements, and consumer medical devices.
The CHPA Analysis of Reportability of Changes to New Drug Application (NDA) Over-the-Counter (OTC) Product Labeling Table was developed to assess the reportability of changes to OTC products subject to new drug applications.
Due to the wide variety of changes that may be encountered after an OTC monograph drug is marketed, it is impossible to address stability requirements for all changes in this guideline. However, guidance from the examples provided here can be used in the decision-making process.
Up and Away reminds families of the importance of safe medicine storage to prevent young children from accidentally getting into medicine. It is led by the CDC and Health in Hand, in partnership with the PROTECT Initiative.
