We have all used over-the-counter (OTC) drugs for one reason or another, whether it be for pain relief, nasal congestion, heartburn, cough, and the list goes on.
Let’s all be honest here, how many of us really pay attention to that ‘drug facts’ label on the side of the bottle? I would guess not too many.
You might think “I’ve taken Tylenol a thousand times, I don’t need to waste time reading all of that.” But, do you know what the maximum daily dosage is? Do you know in which cases you should not take Tylenol?
The U.S. Food and Drug Administration (FDA) provides drug facts labels on all OTC medications (even stuff like toothpaste and deodorant) and the information is standardized and listed in the same order in a way that is easy for people to understand.
Why is reading a drug facts label so important? Well, there are a few reasons you need to add this to your skill set ASAP:
- Avoid accidental overdose
- Be aware of potential side effects
- Avoid taking medications that are not going to help you
Let’s examine each section of the drug facts label and I’ll reveal some surprising facts along the way that you might not have known.
1. Active ingredient: the mojo
The active ingredient is the therapeutic substance in the medication that is meant to relieve symptoms. There may be more than one active ingredient.
Remember that the active ingredient is listed as the generic form of a drug rather than the brand name. Some common examples include ibuprofen = Advil, omeprazole = Prilosec, and polyethylene glycol = MiraLax.
Knowing the generic name of a drug is important because you might be taking more than one OTC medication for your symptoms that contain the same active ingredient.
Acetaminophen (best known as Tylenol) is actually an active ingredient in a lot of different medications used for pain, cold, allergies, and more.
Let’s say you are taking take DayQuil, Tylenol PM, and Excedrin for your cold and flu symptoms. This combination might cause you to inadvertently take way too much acetaminophen. Hello, liver failure.
Watch those active ingredients and how much you are taking.
2. Purpose: what is this substance?
What does the active ingredient do? This tells you the category of the active ingredient. For example acid reducer, pain reliever, antihistamine, or cough suppressant.
Some medications do more than one thing. For example, ibuprofen relieves pain, reduces fever, and fights inflammation. Sprained your ankle? You can kill two birds with one stone with pain and inflammation.
3. Uses: what does it do?
A medication’s uses tell you what the desired effects are after taking said medication. This may be relief or prevention of symptoms.
This should be obvious but If the symptoms you are trying to treat are not listed here, then you probably should not be taking the medication. I find that sometimes people will take medications for prevention when they are more so meant for fast treatment and vise versa.
Example: Tums are for fast relief of heartburn and Prilosec is for prevention and takes time to kick in.
4. Warnings: take heed
There is a lot of information here that you need to pay close attention to.
The warnings list information about:
- Allergies. Obviously, if you have ever been allergic to the active ingredient, you should not take the medication.
- Ask a doctor before use if... This means that if you have a condition listed here, you should not take the medication before consulting with a doctor. For example, people with glaucoma are generally advised not to take antihistamines. This section may also include other medications that you may be taking. For example, antihistamines, sedatives, and alcohol do not mix.
- Side effects. It is always important to be aware of potential side effects so that you know what to look for and can make an informed decision about whether or not this medication is right for you.
- Groups of people who should ask a doctor before taking this medication such as children or women who are pregnant or breastfeeding.
- What to do in case of overdose.
Warnings are pretty straightforward. Don’t ignore these.
5. Directions: here’s what to do
The directions contain instructions for safe, recommended use of the drug.
The directions tell you how much to take and how often. The directions often give you the maximum 24-hour dosage. You should never exceed the recommended dosage unless told otherwise by a doctor.
Also, note that the directions may differ for adults and children. Children’s medications may recommend dosage based on weight or age.
If it is a liquid medication, make sure you are dosing accurately with a correct measuring device such as a measuring spoon, cup, or syringe to avoid mistakes.
So, no, it’s not okay to take 5 ibuprofen tablets at one time when the package says 2 because you think it will work faster. That is not how this works.
6. Other information: miscellaneous stuff
This section specifies anything else you need to know, often related to storage.
Most of the time, the label will tell you the ideal temperature in which to store the medication. Did you know? It is generally not a good idea to store medications in the bathroom where the temperature is fluctuant (it gets hot from the shower).
Also, you will find that some medications are not as effective when exposed to light and need to be kept in a dark place.
7. Inactive ingredients: a misnomer
“Inactive ingredients” are the other substances in the medication that do not contribute to symptom relief (so they say).
If you do a quick Google search, you will find that these ingredients are often vaguely categorized as dyes, preservatives, fillers, and flavorings. People who have allergies to dyes or gluten should definitely pay particular attention to the inactive ingredients list.
Otherwise, you might think that the inactive ingredients don’t matter because they’re not doing anything, right? Not exactly true.
Just because an ingredient is inactive doesn’t mean that it doesn’t help you. It just means that it hasn’t (yet) been reviewed and approved by the FDA as being effective. For example, bitter orange oil is an essential oil sometimes added to topical pain creams for fragrance. It is also thought to be effective for treatment of fungal infections and possibly weight loss.
Additionally, inactive ingredients help keep a medication fresh and stable and also help your body to absorb the medication better. See, they’re not so bad.
Read more about inactive ingredients here.
8. Questions or comments: hit up the manufacturer
All OTC drug facts labels include the phone number for the manufacturer. You can call with questions or share comments about the medication.
Did you experience a weird side effect? Report it to the manufacturer. Make your voice heard.
9. What else will I find on the label?
Other things you will find on the label include:
- Expiration date. A drug that has passed its expiration date is less effective, not poisonous (as some believe). Regardless, you should toss an expired OTC medication.
- Lot code. This number helps the manufacturer identify the product.
- Name and address of manufacturer or distributor
- Net weight and quantity of product
10. Clinical pearls from your healthcare professional
Drug facts labels tell you exactly what a medication is supposed to do, who should and should not use it, and how to take it. This information is important to read and know. Ultimately, it is up to you to stay informed and use the medication safely and wisely.
Drug facts labels can change periodically based on new information. You should always read the label; it’s not a one-time deal.
Dietary supplements and vitamins are not subject to drug facts labels as they are not regulated as medications but rather as food products. A supplement label is completely different.
Many OTC products are packaged in childproof containers. Use them properly. This is a no-brainer, but keep all medications out of sight and reach of children.
If you still don’t understand something on your drug facts label, talk with your doctor or pharmacist.
Meet the Author
Shannon is a nurse practitioner with an array of clinical experience. She is particularly passionate about health promotion and disease prevention. When she's not nurse practitioner-ing or writing, she enjoys reading, cooking, and yoga. You can check out her blog at https://shannonthenp.com.