Johnson & Johnson continues to sell Extra Strength Tylenol over-the-counter in bottles containing hundreds of pills, with each pill containing 500-mg of acetaminophen. This is concerning because the FDA has recently restricted prescription painkillers to 325-mg of acetaminophen or less, calling higher doses unsafe.
What is Tylenol Extra Strength?
Tylenol (acetaminophen) for adults comes in two doses: regular strength (325-mg of acetaminophen) and extra strength (500-mg of acetaminophen). Both are sold over-the-counter in major retail stores and online. The manufacturer, Johnson & Johnson, markets Tylenols as a painkiller and fever-reducer.
Daily Dose of Tylenol Extra Strength Limited to 3,000-mg
In response to an ongoing problem of liver damage in people who used Tylenol as directed, Johnson & Johnson voluntarily decided to limit the maximum recommended daily dose to 3,000-mg per day (six Extra Strength Tylenol) from 4,000-mg per day (8 Extra Strength Tylenol).
The FDA has warned that some people have developed liver damage from taking as little as 2,500-mg of Tylenol per day. Some people have genetic susceptibility to liver damage from Tylenol. The risk of liver damage also increases for people who consume alcoholic beverages.
Warnings Added to Tylenol Extra Strength Cap
Johnson & Johnson added prominent warnings to the caps on Tylenol Extra Strength in August 2013. The new warnings read “CONTAINS ACETAMINOPHEN” and users should “ALWAYS READ THE LABEL.” Click here to read more.
According to a statement from J&J:
“With more than 600 OTC (over-the-counter) and prescription medications containing acetaminophen on the market, this is an important step because it will help remind consumers to always read the label.”
FDA Restricts Rx Acetaminophen Dose to 325-mg Per Pill
On January 14, 2014, the FDA published a Safety Advisory to recommend that manufacturers stop selling prescription painkillers containing more than 325-mg of acetaminophen.
While most manufacturers complied, apparently the warning was not strong enough. Three months later, the FDA issued a reminder. They asked pharmacists not to fill prescriptions for higher-dose medications, and instead contact the prescribing physician to discuss prescribing a lower dose. Click here to read more.
According to the FDA:
“These products are no longer considered safe by FDA and have been voluntarily withdrawn.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.”