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U.S. Department of Health and Human Services

Drugs

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OTC Drug Facts Label

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. Manufacturers may continue to use old-format labels until their inventories are exhausted.

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.

Previously, information about product directions, warnings, and approved uses appeared in different places on the label depending on the OTC product and brand. Finding information about inactive ingredients has also been a challenge for those who may be allergic to an ingredient in a drug product.

Patterned after the Nutrition Facts food label, the Drug Facts label uses simple language and an easy-to-read format to help people compare and select OTC medicines and follow dosage instructions. The following information must appear in this order:

  • The product's active ingredients, including the amount in each dosage unit.
  • The purpose of the product.
  • The uses (indications) for the product.
  • Specific warnings, including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist. This section also describes side effects that could occur and substances or activities to avoid.
  • Dosage instructions--when, how, and how often to take the product.
  • The product's inactive ingredients, important information to help consumers avoid ingredients that may cause an allergic reaction.

Along with the standardized format, the label uses plain-speaking terms to describe the facts about each OTC drug. For example, "uses" replaces "indications," while other technical words like "precautions" and "contraindications" have been replaced with more easily understood words and phrases. The label also requires a type size large enough to be easily read and specific layout details--bullets, spacing between lines, and clearly marked sections--to improve readability.

If you read an OTC medicine label and still have questions about the product, talk to your doctor, pharmacist, or other health care professional.

DrugFactsLabel