FAQs About New Dosage Instructions for Extra Strength TYLENOL® Products
New Dosage Instructions
1. What are the new dosage instructions for Extra Strength TYLENOL®?
The new dosage instructions will lower the maximum daily dose for single-ingredient Extra Strength TYLENOL®
(acetaminophen) products sold in the U.S. from 8 pills per day (4,000 mg) to 6 pills per day (3,000 mg). The
new dosage instructions will also change the dosage interval from every 4-6 hours to every 6 hours. McNeil
Consumer Healthcare is working closely with other manufacturers of acetaminophen-containing products to help
ensure consistency in dosage instructions.
2. Why are you changing the label instructions for TYLENOL® and other adult acetaminophen-containing products?
McNeil Consumer Healthcare is voluntarily implementing new measures, including the label change, that are
designed to help lessen the possibility of accidental acetaminophen overdose and help encourage people who
, and other adult acetaminophen-containing products, to use them appropriately.
3. Will store brand and generic acetaminophen dosage instructions change as well?
McNeil Consumer Healthcare is working closely with other manufacturers of acetaminophen products to help
ensure consistency in dosage instructions.
Safety and Efficacy
4. Are there data showing the efficacy of 1,000 mg of acetaminophen at 6-hour dosage intervals?
Yes. 1,000 mg has been demonstrated to provide effective relief at 6 hours.
5. Can I still recommend 4,000 mg per day of Extra Strength TYLENOL® to patients?
When recommending Extra Strength TYLENOL®, it is important to discuss the new OTC label with patients,
specifically the new 6-hour dosage interval and 3,000 mg total daily dose. Healthcare providers can help
prevent overdose and liver injury by reinforcing the importance of reading and following the OTC label.
For patients whose pain or fever recurs despite the administration of a total daily dose of 3,000 mg, the
new dosing instructions allow for healthcare professionals to exercise their discretion. The efficacy and
safety of TYLENOL®
products at the maximum daily dose of 4,000 mg per day have been well established in
clinical studies and actual use. Patients should be instructed not to take more than 3,000 mg per day
unless under the direction of a healthcare provider.
Other TYLENOL® Products
6. What are the new dosage instructions for Regular Strength TYLENOL®?
Changes to the dosage instructions for Regular Strength TYLENOL®
(acetaminophen) will take place in the
upcoming year. McNeil Consumer Healthcare will be voluntarily lowering the maximum daily dose of Regular
products sold in the U.S. from 12 pills per day (3,900 mg) to 10 pills per day (3,250 mg).
7. What are the new dosage instructions for the other adult acetaminophen-containing OTC products?
McNeil will be revising the dosage instructions for other adult acetaminophen-containing OTC products and
multi-ingredient/upper respiratory OTC products in 2012. The maximum daily dose of other adult
acetaminophen-containing OTC products sold in the U.S. by McNeil with 325 mg of acetaminophen per tablet or
other dosage unit will be lowered to 3,250 mg. There are no plans to change the labeling for TYLENOL®
Arthritis Pain or TYLENOL®
8 HR at this time, and TYLENOL®
PM is already labeled for a maximum daily dose
of 1,000 mg of acetaminophen.
8. What should consumers who have purchased TYLENOL® products with the old label do with those products?
Consumers can continue to use their current TYLENOL®
products, including TYLENOL®
products on store shelves,
as labeled. This change is not being implemented because of any safety concerns inherent with the product
or current labeling. TYLENOL®
remains the brand of pain reliever that doctors recommend more than any other
and that hospitals use most.
9. Are the changes made to Extra Strength TYLENOL® related to the FDA’s announcement limiting the amount of acetaminophen in prescription combination products?
No. The U.S. Food and Drug Administration’s (FDA) January 2011 announcement pertained specifically to
prescription medications containing acetaminophen. There were no required formulation or label changes for
over-the-counter (OTC) medicines containing acetaminophen. McNeil Consumer Healthcare is voluntarily
implementing these changes to help ensure that people who use TYLENOL®
products use them appropriately.