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Reporting a Medication Error

Extra Strength Tylenol Package is Confusing

Published March 1, 2024

Tylenol (acetaminophen) is a common over-the-counter (OTC)medicine used for pain and fever. It comes in many strengths (e.g., 325 mg, 500mg), dosage forms (e.g., tablets, caplets, gelcaps, liquid), and package sizes (e.g.,24 tablets, 100 caplets). For example, regular Tylenol is 325 mg per tablet while Extra Strength Tylenol is 500 mg per tablet. We recently received a report about confusion because of the way an Extra Strength Tylenol package is labeled.

The package of Extra Strength Tylenol contained 325 caplets (Figure 1). But the strength (500 mg) was not clear. In the bottom right corner of the package, it listed the package size (325 caplets) above the strength (500 mg) of each caplet. It could easily be mistaken that each caplet contains325 mg instead of 500 mg. Luckily, the correct dose of Tylenol was taken, so the person was not harmed.

ISMP contacted the manufacturer and asked them not to make packages containing quantities that were the same as the product strength.

Here's what you can do: To prevent errors with Extra Strength Tylenol products that may have confusing labels, do the following:

· Before taking any medicine, read the package carefully. Look at the Drug Facts label to know how much acetaminophen is in each tablet. (Please visit Reading the “Drug Facts” Label for more information.)

· Follow the directions on the Drug Facts label.

· If you, a family member, or friend have a product that has a confusing label, consider throwing it away and buying a new one.

For more safety tips on acetaminophen, go to: Acetaminophen-containing products.

Figure 1. The information that is circled could be confusing because regular strength Tylenol has 325 mg in each caplet. This package has 325 caplets of Extra Strength Tylenol which has 500 mg per caplet.

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