Understand your OTC Drug Facts labels – National Consumers League

You’re taking more responsibility for your own healthcare, medicating yourself for minor ailments like colds, headaches, and stomach aches. But do you know enough about the medicines you take to make informed healthcare decisions for you and your family? Looking at your medication labels carefully – and understanding what they say – will help you use them wisely and avoid problems.

Labels: take them seriously

OTCs are available without a prescription, but they’re still medications. Take them seriously and read the labels each time you take the medication.

It’s a good habit to get into. Your life is hectic. Do you really remember the last time you read the label on your headache medication? Was it before you started taking that new daily prescription, or after? Checking the label each time you use the medication will help to ensure that you won’t have a problem.
Sometimes labels change, so check each time you buy a new OTC. You may inadvertently pick up a bottle of an OTC you’ve taken before, but not notice that the per-pill dosage is higher.

Drug Facts labels

FDA approved a regulation in 1999 requiring that all OTC drug labels contain certain information such as ingredients and doses and warnings in a standardized format. This covers 100,000+ nonprescription products, including sunscreens. In the same way that “Nutrition Facts” helped consumers understand the fat content of foods, FDA hope its “Drug Facts” label will help consumers choose and use OTCs. Here are the sections that appear in the Drug Facts label and how to understand what they mean:

Active ingredients
Active ingredients are the specific chemical ingredients that make a drug work. This section also shows the amount of active ingredient in each dose.

Explains the class of drug. For example, you might see the word antihistamine under “purpose” on a label for an allergy medication.

What you should use the drug for. Make sure you find a medication that relieves only the symptoms you need it to. Ask your healthcare provider or pharmacist for help in choosing the right medications for your symptoms. 


Do not use…
Lists when the product should not be used under any circumstances

Ask a Doctor before use if you have…
Some labels have warnings for people with chronic health problems such as high blood pressure, heart disease, glaucoma, asthma, or diabetes. People older than 65 or younger than two may not be able to take some OTCs. This section explains who should consult a health care provider before taking the medications.

Ask a Doctor or pharmacist before use if you are…
Sometimes the food you eat, other medicines you take, or tobacco can interact with medications. On this portion of the label, companies will list foods or beverages to avoid while taking the medication. Talk to your healthcare provider or pharmacist about all the medications you take, both prescription and over-the-counter. Don’t forget to mention any dietary supplements too; interact with medications.

When using this product…
For most people OTCs are safe, effective, and without complications. But some people do experience side effects. The most common side effects are listed on the label. If you have a side effect to an OTC, re-read the label. Most side effects are minor nuisances, but should be discussed with your doctor. If the side effect is severe or continues, you should stop taking the medication and call your healthcare professional.
This part of the label will also describe substances or activities to avoid while taking the medication.

Two warnings commonly found on OTCs are:

  1. Do not drink alcoholic beverages while taking this medicine. People also ignore or forget this common warning when taking OTCs, but mixing alcohol and medications can cause serious problems. For example, combining alcohol and certain OTC medications for colds, coughs, and allergies can cause excessive sleepiness, mental confusion, or breathing difficulty. Sometimes the combination makes the medicine less effective.
  2. Do not drive or operate heavy machinery. Many people ignore this warning on some OTC medications. Driving after taking some nonprescription medicines such as cold, cough, and allergy or sleep aids can cause impaired judgment and reaction time. Use the medications only as recommended. Remember that medications may affect people differently. It may take 2 or 3 doses before you know how a medication will affect you.

Stop use and ask a doctor if…
When side effects are severe or continue, you should stop taking the medication and call your healthcare professional. This section will explain the serious side effects that warrant an immediate call to your doctor.

Pregnancy/breastfeeding warning
If you are pregnant or breastfeeding, you should always consult a doctor before taking any medication.

Keep out of reach of children
This warning explains what to do incase of an overdose. 


This is where you?ll find out how much of the medication to take, when, how and how often. Do not use medications longer than the time listed on the label. The label will tell you when to consult your healthcare provider if you have not had relief from your symptoms. Persistent symptoms may signal a serious problem that requires attention and treatment by your health care provider.Inactive ingredients

Other Information

This area will include information, as necessary, on how to store the medication.

Inactive ingredients

This is the list of ingredients that are only used as additives for color, flavor, binding, or bulk.

Do you have questions about your over-the-counter medications?

Companies may list a phone number for any questions you may have about the medication.

Ask your health-care provider and/or pharmacist the following:

  • Are there any over-the-counter medicines or dietary supplements I should avoid when taking this prescription medication?
  • Is it okay to take _____ over-the-counter medication with my prescriptions?
  • Do my OTCs or dietary supplements interact with any food or beverages?