New Dosing on Infants' Concentrated Acetaminophen Drops

An industry-wide transition is set to occur on concentrated acetaminophen infants' drops this year. This transition is in accordance with an FDA Advisory Committee's recommendation in an effort to reduce instances of overdose and create uniform dosing instructions.

OLD Concentration of Acetaminophen Infants' Drops: 80mg/0.8mL

NEW Concentration of Acetaminophen Infants' Suspension: 160mg/5mL

This transition is CURRENTLY happening. The OLD concentration is NO longer being produced; eventually it will not be found in the marketplace.

The reason why a change is needed with these drops is to help minimize the potential for dosing errors due to confusion between infants' and children's acetaminophen containing products. The adopting of a single concentration is the FDA Advisory Committee's recommendation to eliminate this confusion and protect patients from accidental overdose.

How does this change help to reduce risk? The concentration change is key to this transition. The amount of acetaminophen to be delivered is the same, but the volume that the medicine is contained in is increased. This increase in volume improves accuracy in measuring, and can help to prevent dosing errors.

McNeil, the makers of Tylenol®, state that the OLD infants' drops can still be used, but reminds caregivers to follow the appropriate dosing instructions.

REMEMBER: Many medications utilize acetaminophen as an active ingredient; check to see what you may be taking for your symptoms, it may contain acetaminophen.  Check with your primary care physician if you are taking multiple sources of acetaminophen, and verify that you are taking a safe dosage.



Jeremy KW Spiewak, CPhT, MA RPhT, BA Chemistry, Doctor of Pharmacy Candidate at Massachusetts College of Pharmacy and Health Sciences

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Kuffner, Edwin K. VP OTC Medical Affairs and Clinical Research. McNeil Consumer Healthcare Division 2011

Tylenol. Drug Facts and Comparisons® eAnswers [online]. 2010. Available through Wolters Kluwer Health, Inc. Accessed August 10, 2010

Additional Resources:

If you have any questions McNeil has made their Medical Affairs Department available at 1 (866) 948-6883 Monday-Friday 9:00am to 4:30pm EST

Original Published:August 2010

Revised:August 2010