For the more than 50 million Americans who live with chronic pain, over-the-counter (OTC) pain relievers may be right up there with “phone, wallet, keys” on the checklist of items to keep with them at all times.

Many people rely on these medications—almost a quarter of American adults use acetaminophen weekly, according to the Protecting Access to Pain Relief (PAPR) Coalition, a multi-stakeholder advocacy coalition that receives part of its financial support from the pharmaceutical industry. Many OTC drugs are generally safe to use, some on an ongoing basis (although it is always important to consult a health care provider about each person’s specific circumstances and possible long-term effects). But it’s not always clear from the labels exactly how to use these medications properly.

Issues include a lack of detailed instructions, too-small fonts, a lack of dosing guidelines for children under the age of 2, little to no information in any language other than English, and few or no visual instructions like diagrams or linked video for people who take in information better that way.

The U.S. Department of Agriculture (USDA) recently overhauled food nutrition labels in an effort to make them easier to understand is: There is talk of doing something similar for OTC medicines, says Ethan Jorgensen-Earp, policy advisor for the PAPR Coalition. “Labeling and the information on it is certainly an access issue” when it comes to safe and effective OTC pain relief, he says.

The lack of uniform labeling standards on these products leaves a lot of room for error when it comes their use, including:

Legibility and clearness of directions

Most dosing instructions appear in tiny, difficult-to-read print. Food and Drug Administration (FDA) guidelines specify the use of 6-point font on labels, which can be too small for some visually impaired or older individuals to read, according to an analysis by the National Institutes of Health (NIH).

The NIH notes that an analysis of 40 OTC products’ label language found the grade level and ease of reading were beyond the average consumer’s capabilities. Beyond that, “none of the products I know of have instructions in other languages,” says pharmacist Jeff Fudin, PharmD, FCCP, FASHP, FFSMB, adjunct associate professor of pharmacy practice and pain management at Albany College of Pharmacy & Health Sciences. Instructions with larger fonts, pictures, videos, or a QR code you can scan with your phone to access instructions in other formats or languages would help.

Measurements and dosages that make sense

Since many Americans don’t use the metric system, “people don’t know that 5 milligrams is equal to one teaspoon,” Fudin says. Some medications come with a dosing cup, but that’s easy to misplace, and consumers are left trying to do conversions to figure out dosage.

Additionally, adult dosages calculated based on a “standard” body weight may not always be accurate. For some medications, the optimal dose won’t be the same for someone who weighs 120 pounds and someone who weighs 240 pounds, says Fudin.

Clear instructions for kids—and dosing guidelines for children under 2

Weight-based dosing for children isn’t always listed on labels. Even when it is, it can be fraught with complications, especially when recommended dosages are given in terms of both age and weight. Which instructions should be followed, for instance, when a seven-month-old baby weighs more than the weight range for that age listed on the dosage chart?

Additionally, some products that are formulated specifically for children may be concentrated to make administering the medicine easier (because there’s less to swallow), but that can also cause confusion.

Drug interactions and safety

OTC pain relievers fall into one of two major categories: acetaminophen (Tylenol), and non-steroidal anti-inflammatory drugs, or NSAIDs, such as ibuprofen (Advil or Motrin) and aspirin. But products that contain both also exist. Certain populations, such as organ transplant recipients, shouldn’t take acetaminophen, and these combination products can be tricky for people who just grab a familiar brand name off the shelf without scanning the ingredients.

OTC medications can interact negatively with prescription drugs, alcohol, or certain foods. They can also have long-term effects, especially among people with pre-existing conditions. “It’s okay to use NSAIDs chronically if recommended by your doctor,” says Fudin. “The issue is if you have a patient who has a high risk for, say, heart problems or kidney dysfunction, and they take NSAIDs beyond their recommended time. Their safety profile isn’t going to be the same as someone without those conditions.”

OTC drug labels also sometimes lack detailed instructions about proper storage. Extreme temperatures or excessive humidity can affect their viability.

Where to go from here

Historically, label modification has been difficult because of the complex regulatory environment for these products, says Jorgensen-Earp. He hopes to see relevant agencies, including the FDA, make this process easier over the next few years. The best way forward is education. “Making people, such as members of Congress, aware of issues that affect you with regard to safe and effective OTC use is helpful,” he says. Advocacy groups like the PAPR Coalition and others can sometimes help amplify specific concerns, too.

In the meantime, someone using an OTC medication for pain relief should always read the instructions thoroughly and investigate potential interactions. Until the labels for OTC pain relievers improve, there is one resource available to alleviate any doubt or confusion about how to take them, and it doesn’t cost a dime or require an appointment, says Fudin: “Ask a pharmacist.” 

Jill Waldbieser