Over-the-Counter (OTC) drugs can be bought without a prescription and used by consumers to self-treat certain conditions. As Americans participate more in their own health care and more prescription drugs are converted to OTC drugs, the use of OTC drugs is growing. They are widely available in supermarkets, drug stores, and other types of stores. Common examples include aspirin, and many cough and cold medicines. Over-the-counter drugs can be safely used without the help of a doctor or another health care practitioner as long as the directions on the package and the label are followed. Pharmacists can help consumers determine which OTC drug to buy. A doctor should be consulted, however, before buying an OTC drug for children.

As of April 1999, there were more than 100,000 OTC drugs on the market, in more than 80 product classes. The Food and Drug Administration (FDA) regulates OTC drugs to ensure that their benefits outweigh their risks and that they are properly labeled. FDA must approve new OTC drugs and new ingredients in OTC drugs before they can be put on the market. Most OTC drugs were developed and marketed before the law required proof of their safety and effectiveness. FDA is evaluating the ingredients and labeling of these older OTC drugs as part of "The OTC Drug Review Program." For each class of OTC drugs, FDA is developing a monograph (kind of like a recipe book) with information about acceptable ingredients, doses, formulations, and labeling. Products that follow the monographs can be marketed without going through a separate FDA review process. This will ensure that these products are safe and effective and help consumers understand how best to use them.

On March 27, 1999, FDA published a final rule to require a new label format on nearly all over-the-counter drug labels. The new format makes the main messages of the labeling more prominent, includes easier-to-read type, presents information in a standard order, and includes other requirements to make it easier to read labels. The new labels were required starting April 16, 1999.