It may seem simple: You’re feeling miserable from being under the weather with the flu , so you go to your nearest drugstore to pick up over-the-counter cold and flu medicine to give you some relief from the fever, body aches and cough.
However, just because it’s sold over the counter doesn’t mean it’s automatically safe for you.
“OTC does not mean risk-free,” says Laura A. Rhodes, assistant professor at the University of North Carolina’s Eshelman School of Pharmacy.
Hidden in plain sight on the medication label is all the info you need, but only if you actually read it and understand what everything means.
“The label has the information, but it is not always easy for patients to quickly understand or compare products, particularly when they are managing multiple symptoms at once,” Rhodes says.
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The 7 Core Sections of an OTC Label (Explained)
The Food and Drug Administration mandates a standardized format for all OTC drug labels to help consumers locate the key elements about the medication they’re taking.
The standard format of the “Drug Facts” label is divided into sections to make it easier to read:
1. Active ingredients and purpose
The first and most important section is “Active Ingredients,” which lists:
— Drug: The specific drug that treats your symptoms. These are FDA-approved components that have been scientifically tested and proven to treat or provide a certain health benefit.
— Amount: The amount of the drug per unit (e.g., 500mg per table) to indicate the strength.
“The most confusing part of OTC labels for many of my patients is the active ingredient and dosing information, especially when different brand name products contain the same medication,” Rhodes says.
Next to each active ingredient is “Purpose,” which states what the drug does or what category it belongs to, such as “antihistamine,” “fever reducer” or “pain reliever.”
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2. Uses
This section specifies the symptoms or conditions the drug is approved to treat, for example, “sneezing” or “itchy throat.” When selecting an OTC drug, look here to determine if it’s the right one for your symptoms.
Some medications address multiple symptoms, but make sure you match your symptoms exactly and don’t “over-treat” if the label lists more symptoms than you have.
“Whenever possible, I encourage patients to talk with a pharmacist about choosing a combination product that fits their needs,” Rhodes says. “Combination products are where people are more likely to accidentally double up on the same medication without realizing it, which increases the risk of serious harm.”
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3. Warnings
This is one of the most crucial sections on the medication label to pay attention to, even though it still has some limitations.
“The warning section of the Drug Facts label is a helpful starting point, but it doesn’t take into account a person’s full medical history or medication list,” says Sue Ojageer, a pharmacist.
Talk to your doctor or pharmacist to review your complete medical history — including any conditions you have, your prescriptions, over-the-counter medications, vitamins and supplements — to make sure everything is safe to take together.
The warnings section is divided into several subsections:
— Do not use. This section lists contraindications to taking the medicine, such as certain medical conditions or taking other specific medications.
— Ask a doctor before use. This means the medication may or may not be safe for you to use, so you should talk to your doctor before taking it. For example, if you have a chronic condition, like high blood pressure or kidney disease, it’s important to run the OTC medication by your doctor to make sure it doesn’t worsen or conflict with your health issue.
— When using this product. This section lists side effects and actions to avoid. For example, it will state that you should not drive because the drug may make you drowsy.
— Stop use and ask a doctor. Certain rare side effects listed in this section may indicate a serious reaction, so if you experience them, stop taking the drug and call your doctor.
— Pregnant or breastfeeding. As with all medications, check with your doctor to make sure an OTC medication is safe to take while pregnant or breastfeeding.
— Keep out of reach of children. This medication may be dangerous for children, especially if taken at a large dose, so call Poison Control if they ingest it.
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4. Directions
When reading a medication label, this is probably the information most people are looking for.
The directions usually give dosage by age and/or weight, as well as how often it’s safe to take.
“I get a lot of questions about how and when to take a medication,” Rhodes says. “Many people focus on the brand name or symptom relief and miss the max daily dose or warning section.”
Safety note: Never use a kitchen spoon to measure liquid medicines, because a kitchen “teaspoon” is often not the correct measurement. Only use the provided dosing cup or syringe.
5. Other information
This section will give storage instructions, such as avoiding heat or humidity, and sometimes electrolyte content, such as sodium and magnesium.
Pro tip: Don’t store medications in the bathroom because there is often too much heat and humidity from the shower.
6. Inactive ingredients
For most people, the inactive ingredients are harmless, but they are crucial to know for those with allergies to dyes, gluten, lactose or preservatives.
“One of the biggest areas of confusion I see is understanding active versus inactive ingredients,” Ojageer says.
For people with diabetes, this section is incredibly important when looking for OTC medicines that may contain added sugar. While diabetic cough medicines are specifically formulated without added sugar or alcohol that can spike your glucose levels, be sure to check inactive ingredients to avoid these ingredients for good measure.
7. Questions or comments?
Find out how to contact the manufacturer for questions that aren’t addressed on the label, although your doctor or pharmacist should always be your go-to for medical guidance.
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3 Common Mistakes to Avoid
Even if you think you understand everything on the medication label, there are some additional safety factors to know when using OTC drugs to avoid some common mistakes.
“It’s not intentional, but comes down to not fully understanding how to read the label (or labels) as a whole,” Ojageer says.
1. The “same ingredient” trap
If you’re taking multiple OTC medications, one easy mistake to make is taking two different brands of drugs with the same active ingredient, known as “double dosing,” which many people don’t realize can be dangerous with OTC drugs.
For example, you might think about taking a multi-symptom cold medicine and a headache pill — not realizing both contain acetaminophen, which can lead to liver toxicity.
“The most concerning mistake I see is unintentional overdosing, especially with commonly used ingredients like acetaminophen or ibuprofen,” Ojageer says. “Most patients focus on the brand name or what the product is marketed to treat, but they don’t always realize that different products can contain the same active ingredient.”
This can happen even if you follow the directions on each product because the active ingredients may overlap.
“The information is there on the label, but unless you know exactly what to look for, it can be easy to overlook,” Ojageer says.
Avoid taking multiple medications with the same active ingredients; or ask the pharmacist which are safe to take together so you don’t exceed the maximum dose.
Active Ingredient Overlap: A Quick Safety Check
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2. Ignoring expiration dates
Although sometimes the expiration date is hard to find, it’s often stamped on the bottom or crimped edge of the box or bottle.
The medication is guaranteed to be safe and effective up to that date, based on stability data from the manufacturer.
“In many cases, medications do not suddenly become harmful after they expire, but they can gradually lose potency,” Ojageer says.
It is possible for some old medications to degrade in a way that can affect you, so it’s best to use medicines within their expiration date.
3. Assuming “natural” means safe
Even if a supplement or herbal product is marketed as “natural,” it’s still important to read the label. That’s because the FDA does not regulate or test these products for safety and efficacy the same way it does drugs.
“There is a common belief that ‘natural’ means safer, but that is not always true,” Ojageer says. “I always tell patients to approach natural products the same way they would any medication: Read the label carefully and check with a health care professional before using them.”
Supplements may:
— Cause side effects
— Interact with prescription medications or affect how another medication works
— Sometimes affect blood pressure or blood sugar
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How to Read an OTC Medication Label: Your Guide to the Drug Facts Box originally appeared on usnews.com