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What over-the-counter drug labels really mean

Claims like ‘All Day,’ ‘Non-Drowsy,’ and ‘Maximum’ might not be what they seem

Published: December 2014

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Navigating the sea of labels on drugstore shelves can leave you feeling sick and confused. Words and phrases like “extra strength,” “PM,” or even “cold and flu” seem to spell relief, but what exactly they’re selling may be less clear. It pays to look closely. Knowing exactly what ingredients—and how much—each pill contains can keep you from taking the wrong medicine for your symptoms or even from an accidental overdose.

What 'extra strength' on a drug label means and why combination products are risky

The confusion exists because there’s limited government regulation of over-the-counter drug-label terms; companies don’t have to stick to standard definitions.

“The variation in the labeling terms is primarily due to marketing by OTC drugmakers and not the science behind how that drug works,” says Carmen Catizone, executive director of the National Association of Boards of Pharmacy, which works with state regulatory boards.

Terms like “extra,” “maximum,” and “ultra strength,” for example, essentially mean the same thing: that the formula has more of its active ingredients than the regular version. It’s up to the consumer to figure out exactly how much more—and how much of the product to safely take.

To get a sense of what consumers are seeing, we sent our secret shoppers to drugstores near our offices in Yonkers, N.Y. We then took a close look at the labels of the more than three dozen products they bought. We didn’t just find inconsistencies: Some product claims were basically meaningless, and some products were simply spin-offs of the original versions.

Below you’ll find the facts behind some common over-the-counter label claims, along with our advice on how to stay safe.

Over-the-counter drug labels demystified

 

Examples: Non-Drowsy Vicks QlearQuil Daytime Sinus & Congestion, Non-Drowsy Walgreens Wal-Fex 12 Hour Allergy

 

What it means: “Non-drowsy” usually indicates an absence of active ingredients that cause drowsiness, like diphenhydramine or dextromethorphan.

 

Our advice: Don’t assume that “non-drowsy” medicine will help you stay alert, even though some products contain ingredients that act as stimulants (such as the decongestant pseudoephedrine, found in Sudafed). Read the Drug Facts label so that you know what you’re getting. And if your medication contains stimulants, avoid caffeine. Otherwise, you risk increased restlessness and difficulty falling asleep.

 

Examples: Aleve PM, Motrin PM, Tylenol PM

 

What it means: Drugs with “PM” in the name usually contain an old-school antihistamine such as diphenhydramine (commonly found in Benadryl Allergy) or doxylamine, which can make you sleepy as a side effect.

 

Our advice: If you have trouble falling asleep, don’t rely on a PM drug longer than a few days. If taken too often, those drugs can worsen your sleeping problems. They can also cause daytime sleepiness, confusion, constipation, and dry mouth, especially for older people. Steer clear of PM drugs if you take blood pressure meds because in combination they may cause excessively low blood pressure. Also, don’t drink alcohol when taking PM formulas; the combo may increase the risk of side effects. And use caution if you drive the next day; you might still be drowsy.

 

Examples: Walgreens Maximum Strength Daytime/Nighttime Mucus Relief Sinus Congestion, QlearQuil Nighttime Sinus & Congestion/QlearQuil Daytime Sinus & Congestion

 

What it means: New on the shelves are day-and-night combination cold-and-flu products packaged and sold in one box. “Daytime” may mean there are no ingredients that make you sleepy; “Nighttime” can mean the product has a drug that causes drowsiness, such as diphenhydramine or doxylamine. The products might also contain a laundry list of active ingredients, which can put you at a higher risk for accidentally doubling medications, especially if you take other drugs, such as acetaminophen (found in hundreds of over-the-counter products). The Mucinex product on the facing page, for example, contains a decongestant (phenylephrine), a pain reliever/fever reducer (acetaminophen), a cough suppressant (dextromethorphan), an expectorant (guaifenesin), and an antihistamine (diphenhydramine) that can cause next-day drowsiness. Walgreens daytime/nighttime cold combo pack contains a pain reliever, two cold medications, plus an antihistamine (diphenhydramine) that causes drowsiness.

 

Our advice: Skip the multisymptom combo packs, especially if you take other over-the-counter drugs. Our medical advisers recommend using single-ingredient drugs whenever you can. (Treat a headache with acetaminophen, for example, rather than taking a pill for a headache plus congestion, fever, and other symptoms you don’t have.)

 

Examples: All Day Strong Aleve Liquid Gels , Up & Up All-Day Allergy Relief

 

What it means: These are extended-release versions of drugs that work over many hours. They may last 12 hours or 24 hours, so for some meds, one daily dose might be all you need; for others, it could be two doses.

 

Our advice: Watch out for nonspecific language that suggests 24 hours. “All Day” might refer either to the part of the day that you’re awake or to an actual day, meaning a 24-hour period. Read labels to determine how often to take the drug. For example, All Day Strong Aleve is taken every 8 to 12 hours for pain relief, and Up & Up is taken once every 24 hours for allergy symptoms.

 

Examples: Excedrin Migraine, Advil Migraine

 

What it means: You might think you’ll get a stronger medicine because migraines are often more severe headaches. But some products contain the same-strength active ingredients as the original versions with different dosage instructions.

 

Our advice: Studies suggest that OTC medicines can help some migraine sufferers with mild or infrequent pain. But read labels to make sure that you’re getting the right medicine. Excedrin Migraine and Excedrin Extra Strength contain the same strength of acetaminophen, aspirin, and caffeine, but the maximum daily dose for the migraine version is no more than two pills per day; for Extra Strength, it’s no more than eight. (One reason: Overuse of OTC pain meds for migraines can cause rebound headaches. When in doubt, consult a doctor or pharmacist.

 

The Food and Drug Administration does review terms and packaging for newly approved OTC drugs, but it doesn’t check label claims like “Max” and “All Day” for drugs already considered safe—that is, those marketed before May 1972, such as acetaminophen. When we contacted the agency to ask whether the lack of standard definitions could be confusing or even dangerous for consumers, a spokesperson referred us to the Drug Facts label (usually on the back of a container) and said that safety concerns and other issues could be reported at fda.gov/safety/medwatch.

 

The surest way to know exactly what you’re getting is to “skip the hype or the promotional wording on the package,” says Marvin M. Lipman, M.D., Consumer Reports’ chief medical adviser. “Pay attention only to the list of active ingredients and the directions for use on the drug container itself.”

For more information check our advice for what OTC drug to take for 12 of the most common ailments.

Extra, Max, Ultra: How much more?


If you take Tylenol Extra Strength, Gas-X Softgels Ultra Strength, or another similarly labeled drug, you probably assume that you’re getting a stronger dose. But there’s no telling exactly how much stronger.


For example, Tylenol Extra Strength contains 54 percent more acetaminophen than the regular strength. Maximum Pepcid AC and Tums Ultra 1000 have 100 percent more of the active ingredient than regular Pepcid AC and Tums Regular Strength.


Here’s why a close read is so crucial: With Pamprin Max Formula, per pill, you’d actually get half the amount of acetaminophen (250 mg) that you would with Pamprin Multi-Symptom (500 mg). The Max version also delivers 250 mg of aspirin and 65 mg of caffeine, while the Multi-Symptom has a diuretic and an antihistamine that could make you drowsy.


Editor's Note:

This article also appeared in the February 2015 issue of Consumer Reports magazine. This article and related materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).


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