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4Consumer Health Information
T
he 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 confu-
sion over different strengths that have
been blamed for past overdoses, some
manufacturers are voluntarily offer-
ing only the less concentrated version
for all children.
Until now, liquid acetaminophen
marketed for infants has only been
available in a stronger concentration
Overdosing Has Been a Risk
that doesn’t require giving the infants
• Read the Drug Facts label on the
as much liquid with each dose.
package very carefully to identify
An April 2011 report from FDA’s Cen-
But right now both concentrations
the concentration of the liquid
ter for Drug Evaluation and Research
of liquid acetaminophen are in cir-
acetaminophen, the correct
(CDER) found that confusion caused
culation. Before giving the medica-
dosage, and the directions for use.
by the different concentrations of liq-
tion, parents and caregivers need to
• Do not depend on a banner
uid acetaminophen for infants and
know whether they have the less con-
proclaiming that the product is
children was leading to overdoses
centrated version or the older, more
“new.” Some medicines with the
that made infants seriously ill, with
concentrated medication. FDA is con-
old concentration also have this
some dying from liver failure.
cerned that infants could be given too
headline on their packaging.
So to avoid dosing errors, some
much or too little of the medicine if
• Use only the dosing device
manufacturers voluntarily changed
the different concentrations of acet-
provided with the purchased
the liquid acetaminophen marketed
aminophen are confused.
product in order to correctly
for infants from 80 mg per 0.8mL or
“Be very careful when you’re giving
measure the right amount of
80 mg per 1 mL to be the same con-
your infant acetaminophen” says Carol
liquid acetaminophen.
centration as the liquid acetamino-
Holquist, director of FDA’s Division of
• Consult your pediatrician before
phen marketed for children—160 mg
Medical Error Prevention and Analysis.
giving this medication and make
per 5mL. This less concentrated liquid
Here’s what the agency wants par-
sure you’re both talking about the
acetaminophen marketed for infants
ents and caregivers to do:
same concentration.
now has new dosing directions and
1 / F D A C o n s u m e r H e a l t h I n f o r m a t i o n / U . S . F o o d a n d D r u g A d m i n i s t r a t i o n
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