The FDA has asked doctors and pharmacists to stop selling prescription drugs containing more than 325-mg of acetaminophen due to the risk of liver damage. However, Johnson & Johnson continues to sell Extra Strength Tylenol over-the-counter with 500-mg in each tablet, often in bottles containing over 300 pills.

What is Extra Strength Tylenol?

Extra Strength Tylenol is a pain-relieving and fever-reducing drug manufactured by Johnson & Johnson. Each pill contains 500-mg of acetaminophen. In comparison, regular-strength Tylenol contains 325-mg of acetaminophen. It is sold over-the-counter in major retailers and online. Bottles of Extra Strength Tylenol contain up to 325 tablets.

Daily Dose of Acetaminophen in Tylenol Limited to 3,000-mg

In July 2011, J&J voluntarily lowered the maximum daily dose of Tylenol was lowered from 4,000-mg per day (8 Extra Strength Tylenol) to 3,000-mg (6 pills). The drug-maker was concerned because over 600 over-the-counter medications contain acetaminophen, making it easy to accidentally overdose — especially when treating multiple ailments at once, such as cold, flu, headache, back pain, and more.

J&J Adds Warnings to Extra Strength Tylenol Caps

In August 2013, J&J added warnings on the cap of Extra Strength Tylenol. The warning will make it explicitly clear that it “CONTAINS ACETAMINOPHEN” and users should “ALWAYS READ THE LABEL.” Click here to read more.

FDA Safety Warnings for Rx Painkillers with High Doses of Acetaminophen

In January 2014, the FDA advised pharmacists who receive a prescription for a combination painkiller containing more than 325-mg of acetaminophen to contact the prescriber and discuss prescribing a lower dose of acetaminophen. Click here to read more.

Apparently the warnings were not strong enough, because the FDA issued a reminder in April 2014 to make themselves clear:

“These products are no longer considered safe by FDA and have been voluntarily withdrawn. We encourage pharmacists to return them to the wholesaler or manufacturer.”