Over-the-Counter Drug Fact Labels

Here's how to decipher your OTC med's drug facts label.

Source: AARP.org | March 16, 2006

Ever had a cold? Headache? Heartburn? Suffer from allergies? If you answered “yes” to any of these questions, chances are that you have reached for an over-the-counter, or OTC, medicine for relief. According to research from Roper Starch Worldwide, 77% of Americans take OTC products to treat common, everyday ailments like these.

OTC medicines help people feel better, get back to work, and be more productive. They are staples in American medicine cabinets. In fact, there are more than 100,000 OTC products available today.

While you can buy them without a doctor’s prescription, it is important to remember that OTC medications are serious medicines and must be used with care. Consider this: less than 30 years ago, more than 700 of today’s OTC medicines were available only with a doctor’s prescription!

The Drugs Fact Label

With so many OTC options available and so many consumers taking an active role in their own healthcare, knowing about your medicines is even more vital. “Carefully reading and following the OTC Drug Facts label is more important than ever before,” according to Linda A. Suydam, D.P.A., president of the Consumer Health Education Center. “It is the best way to get the most benefit from these potent medications and to do so safely.”

The U.S. Food and Drug Administration (FDA) developed the label to make sure users have all the information necessary to choose the right medicine and to use it safely and effectively. The label explains:

what is in the medicine;
how, when, and when not to take or use the medicine;
how to store it; and
when to talk to a healthcare professional.

In addition, every OTC medicine with the label lists this information in exactly the same order, starting with the medication’s active ingredient or ingredients.

Understanding the Terminology

Active Ingredient: The substance that makes the product work, that helps your fever go down for example. Some medicines have more than one active ingredient. And many different medications—both prescription and OTC—may contain the same active ingredient, so be careful not to take two medicines with the same active ingredient unless a doctor specifically tells you to.

Purpose: The type, or category, of medicine, such as an antacid or antihistamine.

Uses: The symptoms or illnesses the product treats. This helps you know if the medicine is right for your condition.

Warnings: Possible side effects, when not to use a medicine, and when to talk to a healthcare professional.

Directions: How and when to take (or give) a medicine. These instructions should be followed exactly as written, unless under a doctor’s specific advice.

Other Information: How to store the product and additional information that is required by FDA about certain ingredients, such as the amount of calcium, potassium, or sodium a product contains.

Inactive Ingredients: Substances (such as flavors or colors) in the medicine, which can be very important if you or someone you care for has an allergy.

Putting it All Together

Millions of Americans rely on OTC medications every day. Despite their convenience, it is important to remember these are real medicines. “They have real benefits when used correctly, but real risks when misused,” cautions Suydam.

While each Drug Facts label contains a great deal of information specific to a particular medication, some general guidelines can help you safely take OTCs or give them to your family.

Pay close attention to the active ingredient. This is especially important if you are taking more than one prescription or OTC medicine, since many drugs contain the same active ingredients. Taking too much of an active ingredient can be dangerous.
Choose those products that treat only the symptoms you actually have.
Never take more of an OTC medicine, or for longer than directed on the label, unless a doctor specifically tells you to do so.
Read and follow the “warnings” and “directions” sections carefully.
Talk to a doctor or pharmacist if you have any questions.