Americans LOVE Drugs. I am not talking about getting high. I am talking about pills we purchase in pharmacies, convenience stores and online. According to a study published in the journal Demography (Oct. 1, 2023), most Americans take medications for more than half their lives. And that does not include OTC remedies! Americans play doctor daily by taking huge quantities of nonprescription medications–from laxatives and pain relievers to cough remedies and heartburn medicine. Do they read OTC medication labels to learn the rules? Probably not!
If It’s OTC It Must Be Safe:
Most people believe that over-the-counter (OTC) medicines are very safe. After all, the FDA makes it clear that it only approves drugs that are 1) effective and 2) safe. So, OTC meds must be super safe. Even if the agency once required a prescription and medical oversight, it changed its mind and decided that a physician was no longer necessary to supervise the use of such products.
Does Anyone Read OTC Medication Labels?
The Food and Drug Administration makes a huge assumption. It seems to believe that people will read the labels of medications approved for OTC sale. That is probably no more than a pipe dream.
Don’t believe us? Here’s proof.
Authors writing in the journal Pharmacy (Dec. 2018) note:
“Unfortunately, multiple studies suggest that less than half of consumers read the entire package labeling before taking OTC medicine.”
The authors continue:
“Eye-tracking studies also suggest consumers spend less time viewing warnings compared to other aspects of package labeling (e.g., the brand name).”
In another study, only 26% of those surveyed even bothered to read the active ingredients on the label (American Journal of Medical Sciences, Nov. 2016). That means that most people may not even know what they are swallowing. Just knowing the brand name tells you nothing about what is in the product. For example, do you know what’s in Tylenol Cold + Flu Severe Warming Honey Lemon Liquid? Would you know what the ingredients phenylephrine, guaifenesin, dextromethorphan and acetaminophen do and what the possible side effects are for each?
The Phenylephrine Debacle:
Did your eyes glide past the ingredient phenylephrine above? We would not blame you. Most people have a hard time pronouncing drug names like phenylephrine (PE), guaifenesin or dextromethorphan.
It took the FDA until September, 2023 to admit that “PE is not more effective than placebo.” Keep in mind that we wrote that this oral decongestant was worthless 50 years ago when writing the first edition of our best selling book, The People’s Pharmacy.
You can read all about this mess at this link. By the way, the FDA admits that each year over 240 million bottles of OTC cough, cold and allergy products are sold containing PE. Americans likely spend more than $1.8 billion on these products. If you are interested in the “Pros and Perils of OTC drugs” you will want to take a few minutes to listen to our radio show # 1360 broadcast on October 24, 2023.
Are You a Label Reader?
Individuals with celiac disease read labels very carefully to avoid products with gluten. People watching their weight often pay close attention to the nutrition labels on their breakfast cereals or frozen dinners.
Do-it-yourselfers generally read all the instructions before they start to put together a piece of furniture from Ikea or begin hooking up a new computer system and router. Others turn to a YouTube video and carefully watch an expert assemble something before tackling the project themselves.
Sadly, though, many people try to figure things out on their own. That often does not end well. We admit that sometimes the strategy works, but sometimes it creates chaos. When it comes to deciding to read OTC medication labels, it wouldn’t matter if nonprescription drugs were completely harmless. Unfortunately, that is not the case!
Do You Read OTC Medication Labels with PPIs?
Let’s take acid-suppressing drugs as one example. By now you know that PPI stands for proton pump inhibitor. AstraZeneca recently agreed to settle over 10,000 claims made against the prescription heartburn drugs esomeprazole (Nexium) and omeprazole (Prilosec). The amount of the settlement was $425 million.
Although the drug company asserts that the claims “are without merit,” plaintiffs’ lawyers maintain that use of these medications led to kidney damage and chronic kidney disease.
Few consumers would associate their OTC heartburn medicine with something so serious as kidney injury. Someone who read the drug label information for Nexium 24HR would be none the wiser about potential kidney problems. Ditto for Prilosec OTC.
Do You Read OTC Medication Labels and follow Instructions?
More importantly, will people read and follow the directions? These include:
“this product is to be used once a day (every 24 hours), every day for 14 days. It may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours…do not use for more than 14 days unless directed by your doctor…you may repeat a 14-day course every 4 months. Do not take for more than 14 days or more often than every 4 months unless directed by a doctor.”
Most people who suffer from frequent heartburn may not pay attention to these directions. After all, it’s only an OTC drug.
But people who take proton pump inhibitors (PPIs) like esomeprazole, lansoprazole or omeprazole for more than two months may find it challenging to stop. Rebound hyperacidity can be uncomfortable at that point (Gastroenterology, July, 2009).
Those who end up taking PPIs long term may run the risk of other possible complications. They include C. diff infections, pneumonia, cardiovascular complications, weakened bones and osteoporosis. Such potential adverse reactions are not listed on the OTC label.
OTC Pain Relievers:
If you’re like most people and don’t bother to read OTC medication labels you could be courting disaster. Take nonprescription pain relievers for example. Many people also take such products for granted. If the FDA says acetaminophen, aspirin, ibuprofen and naproxen are safe, why bother to read instructions or warnings?
Bayer Aspirin:
Products like regular-strength aspirin, acetaminophen (Tylenol), or ibuprofen come with dosing information that is probably familiar.
The makers of Bayer Aspirin offer this:
“adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours.”
Tylenol:
The directions that come with regular-strength (325 mg) Tylenol tablets state:
“take 2 tablets every 4 to 6 hours while symptoms last; do not take more than 10 tablets in 24 hours, unless directed by a doctor.”
Advil:
The dosing information that comes with Advil is a bit different but also allows for 2 tablets at a time:
“1 tablet/caplet/gel caplet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet/caplet/gel caplet, 2 may be used. Do not exceed 6 tablets/caplets/gel caplets in 24 hours unless directed by a doctor.”
Aleve:
Now look at the Aleve (naproxen) dosage.
This NSAID is similar to ibuprofen, but the instructions are quite different:
“Take one tablet, caplet, gelcap or liquid gel every 8 to 12 hours while symptoms last. For the first dose, you may take 2 pills within the first hour. Do not exceed more than 2 tablets, caplets, gelcaps or liquid gels in 12 hours, and do not exceed 3 tablets, caplets, gelcaps or liquid gels in 24 hours. The smallest effective dose should be used. Drink a full glass of water with each dose.”
People who assume that Aleve and Advil are similar and can be taken the same way could end up overdosing on naproxen. That’s because the maximum number of ibuprofen pills in 24 hours is six vs. three for naproxen. Anyone who thinks that Aleve can be taken the same way as aspirin could quadruple the allowable dose.
Truth or Consequences: Do You Know the Limits of Use?
Researchers have found that people routinely take more acetaminophen, ibuprofen and naproxen than is recommended on the label (Pharmacoepidemiology and Drug Safety, Dec. 2012; American Journal of Medical Sciences, Nov. 2016; Pharmacoepidemiology and Drug Safety, March, 2018).
Many OTC products also come with limits on use. People are supposed to stop pain relievers like acetaminophen, aspirin, ibuprofen or naproxen and consult a doctor if pain “lasts more than 10 days.”
As mentioned above, acid-suppressing drugs like Nexium 24HR, Prevacid 24HR and Prilosec OTC come with this caution:
“do not use for more than 14 days unless directed by your doctor; you may repeat a 14-day course every 4 months; do not take for more than 14 days or more often than every 4 months unless directed by a doctor.”
Do you read OTC medication labels and follow such instructions? What about side effect information? Do you routinely check for potential adverse reactions before taking any OTC medicine? Would it do you any good?
Side Effect Information for Rx vs. OTC Drugs:
If a doctor were to prescribe ibuprofen she would see the following black box warning:
“Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction [MI or heart attack] and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
“NSAIDS cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.”
Other warnings for ibuprofen include:
“NSAIDs including IBU tablets, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV [cardiovascular] events.
“…NSAID use increased the risk of MI, hospitalization for heart failure, and death. Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. Use of ibuprofen may blunt the CV effects of several therapeutic agents used to treat these medical conditions [e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers (ARBs)]
“NSAIDs, including IBU tablets, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs.”
“Long-term administration of NSAIDs has resulted in renal [kidney] papillary necrosis [death of tissue] and other renal injury.
There are also warnings about serious allergic and skin reactions. Doctors are told not to prescribe ibuprofen or other NSAIDs late in pregnancy. We recognize that most people zone out after a few such sentences. That’s just a fraction of what doctors see if they look at the official prescribing information for ibuprofen.
If You Read OTC Medical Labels for NSAIDs:
Contrast the official prescribing information for ibuprofen with what you will see on the OTC label for Advil or other OTC ibuprofen products:
“WARNINGS
Allergy alert:
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Heart attack and stroke warning:
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.”
Why You Should Read OTC Medication Labels!
Even though we only provided a fraction of the prescribing information for ibuprofen, you can see for yourself that it is much more extensive than if you just read OTC medication labels. There is also a black box warning for doctors. That means it stands out and grabs their attention. That is not as obvious on the OTC ibuprofen label. Nevertheless, the OTC information is very important and reveals a lot about nonprescription NSAIDs.
Here is a link to an article we have written on NSAIDs:
What Do You Really Know About Scary Ibuprofen Side Effects?
and PPIs:
Why Popular Heartburn Drugs PPIs Are Linked to Premature Deaths
We would very much like to know whether you read OTC medication labels. Please be honest. Do you check out the active ingredients on the label? Do you know what they do? Do you always follow dosing instructions? Do you check for side effect information? Do you read and follow recommendations, especially when there is a limit to the number of days you can take an acid-suppressing drug or a pain reliever like naproxen?
Can you even read the small print? OTC drug labels are supposed to be legible…but we have had difficulty reading the print on some labels. Don’t forget drug interactions. Do you check with the pharmacist to make sure your OTC meds are safe alongside your Rx drugs?
There is a comment section at the bottom of this page. Please let us know about your label-reading behavior so we can share this information with the FDA. Of course your submission will remain anonymous!
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