New Instructions for Tylenol-Coming Fall 2011 to a Pharmacy Near You!

Acetaminophen is one of the most commonly used medications in the United States for treating pain and fever, according to the U.S. Food and Drug Administration (FDA).

In late summer 2011, McNeil, the manufacturer of Extra Strength Tylenol, announced plans for new dosing instructions beginning in Fall 2011. The change in dosing instructions will lower the maximum daily dose recommended for Tylenol products sold in the United States. The dosing changes affect single-ingredient Extra Strength Tylenol products. The proposed change includes lowering the maximum daily dose from 4000 mg per day to 3000 mg per day, or from eight tablets per day to six tablets per day. The dosing interval will also change from two tablets every four to six hours to two tablets every six hours.

Acetaminophen, the active ingredient in Tylenol, can be found in more than 600 over-the-counter and prescription medications including Tylenol, Sudafed, NyQuil, Percocet and Vicodin, just to name a few. If taking multiple products, patients often don’t realize they contain acetaminophen and accidentally take more than the recommended dose.

Why is McNeil changing the dosing instructions?

McNeil announced these changes to ensure the appropriate usage of acetaminophen products and in an effort to decrease the risk of accidental overdose, which still remains a serious public health problem.

The Bottom Line

  • Change in dosing instructions not mandated by the FDA
  • New dosing instructions will appear on Extra Strength Tylenol packaging in the United States beginning Fall 2011
  • According to McNeil, dosing instructions will change for Regular Strength Tylenol and other McNeil products beginning in 2012
  • McNeil is working with other manufacturers of acetaminophen products in an effort to ensure consistency in dosing instructions
  • New dosing instructions will change to two tablets every six hours; maximum daily dose six tablets per day
  • Talk to your doctor or pharmacist about the medications you take, to avoid taking more acetaminophen than is recommended
  • Excess amounts of acetaminophen can cause liver damage
  • When taken as directed, acetaminophen is safe!

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