The Food and Drug Administration (FDA) is urging consumers to carefully read the labels of liquid
acetaminophen marketed for infants to avoid giving the wrong dose to their children. A less
concentrated form of the popular medication is arriving on store shelves, and giving the wrong dose
of acetaminophen can cause the medication to be ineffective if too little is given or cause serious
side effects and, possibly, death if too much is given.

In an attempt to reduce the confusion over different strengths that have been blamed for past
overdoses, some manufacturers are voluntarily offering only the less concentrated version for all
children. Until now, liquid acetaminophen marketed for infants has only been available in a
stronger concentration that doesn’t require giving the infants as much liquid with each dose.

But right now both concentrations of liquid acetaminophen are in circulation. Before giving
the medication, parents and caregivers need to know whether they have the less concentrated version
or the older, more concentrated medication. FDA is concerned that infants could be given too much
or too little of the medicine if the different concentrations of acetaminophen are confused.

Here’s what parents and caregivers need to do:

•Read the Drug Facts label on the package very carefully to identify the concentration of the
liquid acetaminophen, the correct dosage, and the directions for use. 
•Do not depend on a banner proclaiming that the product is “new.” Some medicines with the old
concentration also have this headline on their packaging. 
•Use only the dosing device provided with the purchased product in order to correctly measure
the right amount of liquid acetaminophen. 
•Consult your pediatrician before giving this medication and make sure you’re both talking
about the same concentration. 

Overdosing Has Been a Risk

An April 2011 report from FDA’s Center for Drug Evaluation and Research (CDER) found that confusion
caused by the different concentrations of liquid acetaminophen for infants and children was leading
to overdoses that made infants seriously ill, with some dying from liver failure. So to avoid
dosing errors, some manufacturers voluntarily changed the liquid acetaminophen marketed for infants
from 80 mg per 0.8mL or 80 mg per 1 mL to be the same concentration as the liquid acetaminophen
marketed for children—160 mg per 5mL. This less concentrated liquid acetaminophen marketed for
infants now has new dosing directions and may have a new dosing device in the box, such as an oral
syringe.  

But this is a voluntary change and some of the older, stronger concentrations of acetaminophen
marketed for infants are still available and may remain available. 

Why does this pose a danger?

If a pediatrician prescribes a 5 mL dose of the less concentrated liquid acetaminophen, but the
parents administer a 5 mL dose of the more concentrated liquid acetaminophen, the child can receive
a potentially fatal overdose during the course of therapy.  Conversely, if a physician prescribes a
dose based on the more concentrated liquid acetaminophen and the less concentrated medication is
used, the child might not receive enough medication to fight a fever..

FDA has issued a Drug Safety Communication with more information for consumers about how to avoid
confusion and potential dosing errors with the different concentrations of liquid acetaminophen.

What Should You Do?

Adding to the confusion is the fact that that the box and the bottle may look much the same for
both old and new versions of the medication.  Here’s what consumers need to do --- Read the Drug
Facts label to tell the difference between the two liquid acetaminophen products:

•Look for the “Active ingredient” section of the Drug Facts label usually printed on the back
of an over-the-counter (OTC) medication package.  
•If the package says “160 mg per 5 mL” or “160 mg (in each 5 mL)”, then this is the less
concentrated liquid acetaminophen.  This medication should come with an oral syringe to help you
measure the dose. 
•If the package says “80 mg per 0.8 mL” or “80 mg per 1 mL,” then this is the more
concentrated liquid acetaminophen. This product may come with a dropper. 

If the dosing instructions provided by your healthcare provider differ from what is on the label,
check with a healthcare professional before administering the medication.  Do not rely on dosing
information provided from other sources such as the Internet, old dosing charts, or family members.

It is important to understand that there is no dosing amount specified for children younger than 2
years of age.  If you have an infant or child younger than 2 years old, always check with your
healthcare provider for dosing instructions. 

Acetaminophen is marketed for infants under brand names such as Little Fevers Infant Fever/Pain
Reliever, Pedia Care Fever Reducer Pain Reliever and Triaminic Infants’ Syrup Fever Reducer Pain
Reliever. There are also store brands on the shelves.  

Every year, more than 60,000 young children end up in emergency rooms because they got into
medicines while their parent or caregiver was not looking. The Up and Away and Out of
Sight educational program was created to remind families of the importance of safe medicine
storage. To help keep children safe through proper medicine storage, Up and Away and Out of
Sight educates parents and caregivers by: reminding them about safe medicine storage;
providing them with information and tools to keep their child/children safe; and encouraging them
to take action. 

Up and Away and Out of Sight is part of the PROTECT Initiative, in partnership with
the Centers for Disease Control and Prevention (CDC) and the Consumer Healthcare Products
Association (CHPA) Educational Foundation. The National Council on Patient Information and
Education (NCPIE) is pleased to be a partner of the Up and Away and Out of Sight
educational program. 

The Agency for Health Care Research and Quality (AHRQ) has released a new toolkit to help hospitals
improve their medication reconciliation processes to reduce adverse drug events. The Medications at
Transitions and Clinical Handoffs (MATCH) Toolkit provides step-by-step instructions on how to
improve a medication reconciliation process, from planning to pilot testing, implementation, and
evaluation. A workbook is included that helps users implement the Toolkit.  

The Be Medicinewise campaign encourages all Australians to be medicine wise by asking the right
questions of trusted information sources, including NPS and their doctor or pharmacist. Tips and
resources for consumers gets people thinking and helps them better interact with their health
professionals and make better medicines decisions. 

Working with a growing coalition of public and private organizations, FDA has launched the
Preventing Surgical Fires Initiative to reduce the risk of surgical fires. For consumers
there is an "Information for Patients" page which contains 10 things patients should know about
surgical fires