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U.S. Food and Drug Administration
FDA Consumer magazine
July-August 2002
Table of Contents

New OTC Drug Facts Label

Whenever you use an over-the-counter (OTC) medicine, reading the drug label is important for taking care of yourself and your family. The label tells you what a medicine is supposed to do, who should or shouldn't take it, and how to use it. OTC medicine labels have always contained usage and safety information for consumers, but now the information will be more uniform and easier to read and understand.

Most OTC drug manufacturers were required to begin using the new, standardized label on the products beginning on May 16, 2002. The OTC regulation was finalized in March 1999, and manufacturers were given until the May 2002 effective date to change product labels. Manufacturers may still distribute products bearing older labels until their product inventories are exhausted.

The OTC labeling rule applies to more than 100,000 OTC drug products. Most OTC medicines manufactured after May 2002 will carry the new Drug Facts label. But certain OTC products, such as sunscreens, aren't required to use the format until 2005. Many manufacturers voluntarily used the new OTC label before the effective date, and the Food and Drug Administration estimates that a large number of medicines with the new labeling are already on store shelves.

Before simplifying the OTC label, the FDA conducted extensive research on how consumers use OTC drug labels. One major problem has been the readability of OTC drug labels, especially for older Americans, who purchase almost 30 percent of the nonprescription drugs sold in the United States. The FDA also found that consumers thought words like "indications," "precautions" and "contraindications" were too technical and confusing.

Previously, information about product directions, warnings and approved uses has 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 new 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 medication.
• The uses (indications) for the drug.
• 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. The warnings section also describes side effects that could occur and substances or activities to avoid.
• Dosage instructions addressing when, how, and how often to take the medication.
• The product's inactive ingredients, which is important information for those with specific allergies.

Along with the standardized format, the new drug 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 eliminated. The new 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.

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