Drug Labeling & Ingredient Review

Whenever you use an over-the-counter (OTC) medicine, reading the drug product’s labeling is important for taking care of yourself and your family. The label tells you what the medicine is supposed to do, who should or shouldn’t take it, and how to use it. The labeling of OTC medicines has always contained usage and safety information for consumers. With the introduction of the “Drug Facts” label, the information is more uniform and easier to read and understand.

In the Federal Register of March 1999, the Food and Drug Administration published the OTC Drug Facts Label regulation. This regulation required most OTC drug products to comply with the new format and content requirements by May 2002.

The OTC labeling rule applies to more than 100,000 OTC drug products.

Before simplifying the OTC label, the FDA conducted extensive research on how consumers use OTC drug product labels. One major problem has been the readability of the labels, especially for older Americans, who purchase almost 30 percent of the OTC drugs sold in the United States. The FDA also found that consumers thought words like “indications,” “precautions,” and “contraindications” were confusing and not easily understood.

“FDA Registration Assistance” can help you make sure your OTC Product Label is up to date and following all the FDA Guidelines to begin please CONTACT US.