Daily Maximum Dosage of Tylenol will Reduce from 4,000 mg to 3,000 mg
Earlier today, McNeil Consumer Healthcare- a Johnson & Johnson company-announced that in an effort to decrease the risk of an accidental overdose, the daily recommended dose of Tylenol (active ingredient is acetaminophen) has been lowered. The maximum recommended daily dose of 500 mg Extra Strength Tylenol tablets will be reduced from 4,000mg per day to 3,000 mg per day (i.e., from 8 to 6 per day).
Acetaminophen (also known as paracetamol) is a commonly available, over-the-counter (OTC) analgesic and antipyretic drug used by people for headaches, minor aches, and pain. Many cold and flu medications commonly have it in their composition. When used in combination with opioid analgesics, acetaminophen can also be used to relieve severe pain.
Over 600 OTC and prescription drugs including Vicodin, Percocet, NyQuil, and Tylenol contain acetaminophen in their composition. Each week, over 50 million people in the USA use acetaminophen.
Vice President of OTC Medical Affairs and Clinical Research at McNeil Consumer Healthcare, Edwin Kuffner, M.D , said:”Acetaminophen is safe when used as directed. But, when too much is taken (overdose), it can cause liver damage. Some people accidentally exceed the recommended dose when taking multiple products at the same time, often without realizing they contain acetaminophen or by not reading and following the dosing instructions. McNeil is revising its labels for products containing acetaminophen in an attempt to decrease the likelihood of accidental overdosing in those instances.”
The company told the FDA that new dosing instructions for Extra Strength Tylenol are expected to appear on product packages in the last quarter of 2011. Lower daily maximum recommendations for other Tylenol products, including Regular Strength will be included in the packaging next year.
The company has recommended that the users follow current label instructions. Although most people identify acetaminophen as an effective pain and fever reliever, there are very few who understand the risks associated with drug overdose. Overdose or misuse of acetaminophen have resulted in acute liver failure and occasionally even death in people. These serious adverse events have been caused by an accidental overdose in a vast majority of cases.
In an article featured in the June 2011 issue of the American Journal of Preventive Medicine, lead author, Jennifer King wrote: “(our study) . . . has demonstrated that consumers have very poor understanding of active ingredients and simultaneously offers a patient-centered strategy for packaging that uses icons and plain language to increase awareness of active ingredient and safe use. Standard plain-language messages and icons designed to help consumers more quickly identify the active ingredient and maximum dose on traditionally text-heavy labels received positive feedback among a diverse group of consumers.”