Most people play doctor without knowing the rules of the game. What we mean is that people frequently swallow pills they buy over the counter without bothering to read the instructions or the warnings. Many of these drugs were once only available by prescription. If you don’t read OTC medication labels and heed the advice, you can get into all sorts of trouble.
If It’s OTC It Must Be Safe:
Many people assume that if they can buy a drug without a prescription it must be 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. That’s probably why most people don’t thoroughly read OTC medication labels.
“Unfortunately, multiple studies suggest that less than half of consumers read the entire package labeling before taking OTC medicine.”
In one 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?
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 try to figure it out on their own. Sometimes that strategy works and sometimes it creates chaos.
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 take such products for granted. If the FDA says acetaminophen, aspirin, ibuprofen and naproxen are safe, why bother to read instructions or warnings?
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.”
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.”
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.”
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.”
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?
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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:
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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:
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?
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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Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” Read Joe's Full Bio.
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Catlin, J. R. & Brass, E. P. “The Effectiveness of Nonprescription Drug Labels in the United States: Insights from Recent Research and Opportunities for the Future,” Pharmacy, Dec. 2018, doi: 10.3390/pharmacy6040119
Cryer, B., et al., “Overuse and Misperceptions of Nonsteroidal Anti-inflammatory Drugs in the United States,” American Journal of Medical Sciences, Nov. 2016, doi: 10.1016/j.amjms.2016.08.028
Kaufman, D. W., et al, “Prevalence and correlates of exceeding the labeled maximum dose of acetaminophen among adults in a U.S.-based internet survey,” Pharmacoepidemiology and Drug Safety, Dec. 2012, https://doi.org/10.1002/pds.3350
Kaufman, D. W., et al, “Exceeding the daily dosing limit of nonsteroidal anti-inflammatory drugs among ibuprofen users,” Pharmacoepidemiology and Drug Safety, March, 2018, https://doi.org/10.1002/pds.4391
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