Over-the-Counter Drugs

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Over-the-counter (OTC) drugs are drugs you can buy without a prescription.

It is very important to read the label when using OTC drugs. It is the only way to know how to use the drug the right way.

FDA passed a law about labels on OTC drugs. The law says that all OTC products must have a new label called “Drug Facts.” This label will show people the best, safest way to use OTC drugs.

How is the new label different?

• It will use common words that are easy to understand.
• The print will be bigger, making it easier to read.
• The label will look the same, and be in the same place, on every product.

What will be on the label?

• Active ingredients—what is in the product that makes it work
• Purposes—what the drug is for
• Uses –what problems it is used to treat
• Warnings—who should not take the product, problems to watch out for
• Directions—how much to take, when to take it
• Inactive Ingredients—what else is in the product. People can see if they are allergic to something in the product.

How will the new label help me?

• It will help you compare products and choose the best one for your illness.
• The product will work its best because you can use it the right way.
• You will have all the information you need to stay away from problems.

To Learn More...

FDA Center for Drug Evaluation and Research
OTC Labeling: Questions and Answers
Phone: 1-888-INFO-FDA (1-888-463-6332)

FDA Office of Women’s Health
www.fda.gov/womens

2007