How to Read an OTC Drug Facts Label

What is an over-the-counter (OTC) medicine?

Over-the-counter (OTC) medicines are medicines you can buy without a doctor’s prescription. Examples of OTC medicines include non-prescription pain relievers, allergy, and cough and cold medicines. You can typically find these medicines near the pharmacy in your local grocery stores and drug stores.

What is an OTC drug facts label?

Every OTC medicine has a drug facts label printed on the box. This label gives you important information about what the medicine does, how to safely take it and who shouldn’t take it. This is one example of a drug facts label for an OTC antihistamine (allergy) medicine:

How do I read an OTC drug facts label?

Drug facts labels always list the same information in the same order. See the list below for an explanation of what you’ll find in each section of the label. If you have questions about a medicine, ask your family doctor or pharmacist.

1. Active Ingredient. The active ingredient is the chemical compound in the medicine that works to relieve symptoms. It is always the first item on the label. There may be more than one active ingredient in a product.
2. Uses. This section lists the symptoms the medicine is meant to treat. Uses are sometimes called “indications.”
3. Warnings. This safety information will tell you if you should talk to a doctor before you take the medicine, the possible side effects of the medicine, and what other medicines, foods or situations you should avoid while taking this medicine.
4. Directions. This section tells you how much medicine you or your child should take and how often you should take it.
5. Other Information. Any other important information, such as how to store the medicine, will be listed here.
6. Inactive Ingredients. An inactive ingredient is anything in the medicine that isn’t meant to treat a symptom. This can include preservatives, binding agents and food coloring. This section is important for people who know they have allergies to food coloring or other chemicals.
7. Questions or Comments. A toll-free phone number for the manufacturer is given in case you have any questions or want to share your comments about the medicine.

Funding and support for this material have been provided by the Consumer Healthcare Products Association.