Key takeaways:
Over-the-counter (OTC) medicine labels, also known as “Drug Facts” labels, contain a lot of information. And it’s easy to feel overwhelmed when looking at one. As long as you read carefully and know what to look for, you shouldn’t miss any important details.
All parts of an OTC medicine label are important. But you should pay special attention to the warnings section. It will tell you if it’s safe for you to take, or if you should talk to your healthcare provider or pharmacist first.
Your healthcare provider or pharmacist can clear up any questions you have about the information on an OTC medicine label.
If you’ve ever felt under the weather, odds are that you’ve taken an over-the-counter (OTC) medication to help get you back to normal. OTC products have many different uses, such as relieving cold symptoms or treating heartburn. But before you start taking one, you should make sure to read through the label first.
An OTC medicine label, also known as a “Drug Facts” label, may seem a little overwhelming at first. That’s because it contains a lot of information, and you may be unsure where to start.
But all OTC medicine labels must have the same key sections. And once you know what to look for on one label, you can apply that knowledge to others. Below we’ll provide a breakdown of the elements that make up an OTC medicine label — active ingredients, warnings, and more.
The active ingredient section is located at the very top of an OTC medicine label. It lists the part(s) of the medication that has an effect on your body. It also indicates how much of each active ingredient is in each unit (such as a capsule or tablet).
Many OTC medications only have one active ingredient. One example is Tylenol, which contains acetaminophen. But combination products for multi-symptom relief (like cold and flu products) will have more than one listed in this section.
This section will also indicate the purpose of each active ingredient. For example, acetaminophen’s purpose in Tylenol is to work as a pain reliever/fever reducer. Ask your healthcare provider or pharmacist if you’re not sure what an active ingredient does.
Keep in mind: It’s important not to overlook the active ingredients if you tend to buy OTC products based on the brand name. Sometimes, the brand name is associated with a line of products, not a specific ingredient. Checking this section can help ensure you’re taking the right ingredients. It can also help you to avoid doubling up on ingredients.
The uses section tells you what symptoms the medication can be used to treat or prevent. One example is a runny nose or sneezing from seasonal allergies.
Some medications only have one or two listed uses, while others have several. For example, Pepto-Bismol (bismuth subsalicylate) can treat a variety of symptoms, including upset stomach, diarrhea, and heartburn. Make sure to look at the uses of a medication to see if they match up with your symptoms.
The warnings section tells you if there are any risks associated with the medication. It might also have information about who shouldn’t use the medicine, or who should use it with caution. Sometimes, medication-specific warnings will be listed first. For example, any aspirin products will have a warning for Reye’s syndrome. This is a rare but serious illness linked to aspirin use that most commonly happens in kids under 19 years old.
Following any medication-specific warnings, this section is often split into multiple parts. We’ve detailed some of the specific warnings you might find on your medicine label below.
When using this product. Not all labels will have this information. But this part may include potential side effects to know about, like drowsiness. Information about avoiding certain substances or activities while taking the medication may also be included.
Do not use. This part of the warnings section describes situations where the OTC medication isn’t appropriate for you. For instance, you shouldn’t use a medication if you’re allergic to one of the active ingredients.
Ask a doctor before use. This can alert you to risk factors that can make serious side effects more likely. For example, Tylenol can cause liver damage. So, you should check with your healthcare provider before taking it if you have liver disease.
Ask a doctor or pharmacist before use. This is meant to highlight information such as serious interactions with other medications. For example, Tylenol can interact with the blood thinner warfarin and increase the risk of bleeding. So, you should talk to your provider or pharmacist before starting Tylenol if you’re taking warfarin.
Stop using and ask a doctor. This part gives examples of when you should contact your healthcare provider after you’ve been taking the medication. Typically, it will include duration of use (e.g., more than 3 days) and/or symptoms (e.g., fever) that warrant a call to your provider.
If pregnant or breast-feeding. If you’re pregnant or nursing, most labels will say to talk to your provider before taking an OTC medication. That’s because some medications can harm a fetus if you’re pregnant. And others can even pass through the breastmilk if you’re nursing.
Keep out of reach of children. Young children should only have access to medications when a parent is watching. That’s because children could mistake a medication for candy and accidentally take more than they should.
Overdose warning. As with prescription drugs, it’s possible to take too much of an OTC medication. Following the directions (discussed below) can help prevent this. Not all OTC medications have this section. But it will direct you to get medical help or call Poison Control if you think you or a loved one has taken too much.
The directions section tells you exactly how to take the medication. Most labels will tell you how much you can take at a time. It should also tell you how often you can take it, and the total amount you can take in a 24-hour period.
Some OTC medications are safe for both adults and children to take. But the directions may be different based on age, body weight, or other factors. It’s important to read the directions closely to make sure you’re taking (or giving) the right dose. Ask your pharmacist or pediatrician if you have any questions about giving the medication to your child.
Keep in mind: Some versions of OTC medications are made for adults, while others are made for children. For example, Children’s Tylenol liquid and chewables are only meant for children under 12 years old. And the directions are based on a child’s body weight. Other Tylenol products are meant for adults, or people ages 12 and older. Read the label to make sure you have the right product for your needs.
This section of the OTC medicine label has any additional information that you’ll need. For example, it may tell you where or how you should store the medication in your home. This information is important because improper storage (such as a bathroom cabinet) can affect your medications.
Ingredients like sodium, calcium, or potassium are required to be listed in this section. This is also the case for specific artificial sweeteners. One example is phenylalanine, which can be harmful for people with certain health conditions.
Inactive ingredients are those that don’t have a therapeutic effect on your body. They typically have many purposes. For example, some are added to color the medication or give it a flavor. And most importantly, some inactive ingredients hold everything in the medication together or keep it stable on the shelf.
It’s also important not to overlook the inactive ingredients section, especially if you’re allergic to any substances (like artificial dyes).
Keep in mind: Some medications are made by a few different manufacturers. So, they may look a little different due the inactive ingredients that are used. But the active ingredient(s) will still be the same.
In addition to the OTC medicine label, there’s additional information on the container or packaging that you may need to know.
The expiration date. After the expiration date, medications may not be as effective and may be harmful to take. Check this date before taking a medication. If it has expired, there are many ways for you to safely get rid of it.
The lot or batch number. The manufacturer assigns this number to each batch of medication that’s made. It’s usually located on the medication container. And it’s especially important if the medication is recalled, so you can check if your product has been affected.
Manufacturer information. The manufacturer information tells you what company made the medication, along with its contact information. The label may also have the company that distributed the medication.
The net quantity. This is the quantity of medication that’s in the package (such as total number of capsules). You can typically find this information on the front of the container or packaging.
Before you buy or take an OTC medication, it’s important to look at the label first. Each label has a lot of information, and it might feel overwhelming at first glance. But taking it section by section will help prevent you from missing important details.
Talk to your pharmacist or healthcare provider if you have any questions about an OTC medicine label. They can help you understand how to take the medication, what it’s used to treat, and more.
Code of Federal Regulations. (2023). Subpart C – labeling requirements for over-the-counter drugs.
MedlinePlus. (2022). Storing your medicines.
U.S. Food and Drug Administration. (2017). The over-the-counter medicine label: Take a look.
U.S. Food and Drug Administration. (2023). Medicine and pregnancy.
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