Drug labels provide key details for safely and effectively taking medication. But that information is frequently ignored and, research shows, often misunderstood even when it is read.
The Drug Facts label on over-the-counter medications, which is regulated by the Food and Drug Administration, is supposed to be consumer friendly, but can still be a challenge to comprehend. But whether you’re purchasing an OTC medication or picking up a prescription at the pharmacy, it’s worth the extra effort to understand what you’re taking.
Also, even if you’ve taken a drug before, you should continue to read labeling information, since that can change over time as more is learned about a drug and reactions to it.
OTC labels are typically broken up into at least six sections:
This details the ingredient that has an effect on the body or is active in treating a symptom or preventing disease. This also details how much of the drug is in each dose of medication, and what the medication is used for, such as to relieve pain or treat a cough.
Before taking a new medication, you’ll want to know if you’re taking anything else that has the same active ingredient, says Erin Selby, an executive resident at the National Community Pharmacists Association. For instance, acetaminophen – or brand-name Tylenol – is in lots of drugs. Among other risks, taking too much can damage the liver.
The symptoms the medication aims to treat, relieve or prevent are covered here. Typically, it’s best to stay within the uses listed, Selby says. If it’s not clear whether the medication is right for what ails you, speak with a pharmacist or your doctor before taking that first dose.
Commonly the longest section on the label, this outlines medication side effects, and other cautions. That includes when to stop taking a medication, when to call your doctor, and substances to avoid while on the drug, such as alcohol or certain medications.
The warnings also spell out who might not be a good candidate for a drug; for instance, in some cases, women who are pregnant or breastfeeding, or older individuals.
Follow to the letter – and dose. Dosing is based on an individual’s age and sometimes weight, particularly for children. The FDA also advises that adults who weigh less than 95 pounds use children’s OTC medicines and follow that dosing chart.
More is not better. Taking a higher-than-recommended dose only increases the risk for harm. If you want a drug to be safe as well as effective, it’s imperative that you follow the directions closely.
This mainly details how to store the drug; most OTC medications are stored at room temperature. So keeping them in your car is probably not OK when it’s really cold or really warm outside, says Dan Degnan, a clinical assistant professor of pharmacy practice at the Purdue University College of Pharmacy.
Since heat, humidity, and moisture can damage drugs, you might also rethink storing medications in your bathroom.
Less commonly, dyes and preservatives can be problematic for people allergic to them. So it’s worth considering all ingredients, not just the active drug.
Unlike with OTC drugs, you won’t find all of the FDA-approved prescription labeling on the side of the bottle. Rather, the prescribing information is contained in a package insert that provides details and directions geared toward healthcare providers rather than patients.
The pages-long material helps doctors and pharmacists counsel patients. Primarily for professional reference, it’s typically not written in consumer-friendly language, and the FDA doesn’t require that pharmacies provide it to users (though some do). Still, the information is publicly available. You can find complete, up-to-date prescription labeling information at DailyMed.
In speaking with your doctor or pharmacist about a new prescription, make sure you understand how to take your medication and any special instructions – including for storage. Also, check that you’re not taking any other drugs that could be unsafe to use with it.
As with OTC meds, don’t assume you know everything about a prescription you’ve been taking for some time. New information regarding serious risks can lead to a boxed warning, commonly called a black box warning, being added. This is the most significant advisory of its kind.
Some of the most commonly prescribed drugs with a black box warning are antidepressants such as Zoloft (sertraline hydrocholoride) and Prozac (fluoxetine hydrochloride) to warn about an increase in suicidal thoughts and behaviors; powerful pain medications such as OxyContin (oxycodone) highlighting the potential for addiction; and a class of antibiotics called fluoroquinolones, for increased risk of tendinitis and tendon rupture.
Along with checking for updated drug warnings, enter the name of your medication into the F.D.A.'s Recalls, Market Withdrawals and Safety Alerts database to make sure it hasn't been recalled. And always remember to read the full drug label, even if it sometimes seems easier to ignore it.
So always remember to read drug labels, even if it seems easier to ignore them.
Michael Schroeder is a freelance health writer and editor based in Westfield, Indiana.
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