Developing Consumer-Centered,

Nonprescription Drug Labeling

A Study in Acetaminophen
Jennifer P. King, MPH, Terry C. Davis, PhD, Stacy Cooper Bailey, MPH,
Kara L. Jacobson, MPH, Laurie A. Hedlund, BA, Lorenzo Di Francesco, MD,
Ruth M. Parker, MD, Michael S. Wolf, PhD, MPH

Background: In the U.S., acetaminophen overdose has surpassed viral hepatitis as the leading cause
of acute liver failure, and misuse contributes to more than 30,000 hospitalizations annually. Half to
two thirds of acetaminophen overdoses are unintentional, suggesting the root cause is likely poor
understanding of medication labeling or failure to recognize the consequences of exceeding the
recommended maximum daily dosage.

Purpose: Elicit subject feedback about active ingredient and dosing information on over-the-
counter (OTC) acetaminophen and elicit feedback on proposed plain-language text and icons.

Methods: Six focus groups, preceded by individual interviews, were conducted in April 2010 among
45 adults in two cities from two clinics and an adult basic education center. The individual interviews
evaluated knowledge of OTC pain relievers, attention to product label information and literacy level
while the group discussion elicited preference for label messages and icons. Analyses were conducted
from April to June 2010.

Results: Forty-four percent read at or below the 6th-grade level. Individual interviews revealed that
⬍50% of participants routinely examine product label information. Only 31% know acetaminophen
is in Tylenol®. The groups achieved consensus on a preferred icon for acetaminophen, desired
explicit statement of potential liver damage in the warning against simultaneous use of acetamino-
phen products, and indicated preference for an icon and wording for maximum dose.

Conclusions: With the high prevalence of OTC use, a consumer-centered approach to developing
icons and messages to promote awareness and safe use of acetaminophen could benefıt consumers.
(Am J Prev Med 2011;40(6):593–598) © 2011 American Journal of Preventive Medicine

A
cetaminophen, found in prescription and single-
ingredient or combination over-the-counter
(OTC) products, is one of the most commonly
used pain medicines in the U.S., with 25 billion doses sold
in 2008.1,2 Despite its popularity, recent attention has
focused on adverse events resulting from the misuse of
From the Health Literacy and Learning Program, Division of General
Internal Medicine, Northwestern University Feinberg School of Medicine
(King, Bailey, Hedlund, Wolf), Chicago, Illinois; the Departments of Med-
icine and Pediatrics, Louisiana State University Health Sciences Center
(Davis), Shreveport, Louisiana; the Department of Health Policy and Man-
agement, Rollins School of Public Health of Emory University (Jacobson);
and the Division of General Internal Medicine, Emory University School of
Medicine (Di Francesco, Parker), Atlanta, Georgia
Address correspondence to: Jennifer P. King, MPH, Northwestern Uni-
versity, Feinberg School of Medicine, Division of General Internal Medi-
cine, 750 N. Lake Shore Drive, 10th Floor, Chicago IL 60611. E-mail:
jenniferking@northwestern.edu.
0749-3797/$17.00
doi: 10.1016/j.amepre.2011.02.016
acetaminophen. In the U.S., acetaminophen overdose has
surpassed viral hepatitis as the leading cause of acute liver
failure, and misuse contributes to more than 30,000 hos-
pitalizations annually.2–5 Acetaminophen-related adverse
drug events have been linked to consumers exceeding the
maximum daily dosage and simultaneously using multi-
ple acetaminophen products (both prescription and
OTC).4 Notably, half to two thirds of overdoses are unin-
tentional,3–5 suggesting the root cause is likely poor un-
derstanding of medication labeling or failure to recognize
the consequences of exceeding the recommended maxi-
mum daily dosage.
In 1999, the Food and Drug Administration (FDA)
issued regulations aimed at standardizing the format and
content of OTC medication labels with the goal of facili-
tating safe and effective use by consumers.6 The FDA
stated that labeling is the most important means to ensure
that consumers have access to important warning infor-

© 2011 American Journal of Preventive Medicine • Published by Elsevier Inc. Am J Prev Med 2011;40(6):593–598 593
594 King et al / Am J Prev Med 2011;40(6):593–598
mation each time a drug product is purchased and used.
In 2009, in an effort to prevent unintentional acetamino-
phen overdose, the FDA ruled that the term acetamino-
phen must appear prominently on the front panel of OTC
products to enhance consumer awareness of the active
ingredient.7 Additionally, a specifıc warning message was
required on both the outer and immediate container to
alert consumers that taking too much acetaminophen can
potentially cause liver injury.7
A framework has been proposed for OTC label de-
velopment that includes (1) identifying key messages
to be communicated to consumers via the label;
(2) development and testing of hypotheses of how
messages can best be communicated; and (3) perform-
ing a label comprehension study.8 A priori key mes-
sages that the research team intended labels to commu-
nicate include (1) acetaminophen is the active
ingredient; (2) simultaneous use of multiple acetamin-
ophen products can cause liver damage; and (3) the
maximum daily dose of the product. Although health
literacy research has emphasized the importance of
plain, concise language, a number of studies also have
found the use of icons or pictures to be helpful in
drawing attention to and supporting patient compre-
hension and recall of medication information.9 –11
The present study sought to identify patient-centered
icons and messages to convey important information for
the safe use of acetaminophen. In addition, how consum-
ers approach and think about OTC medications, specifı-
cally their attention to labels and current knowledge of
key messages surrounding the active ingredient, was
explored.
Methods
The current study used a qualitative research design used previ-
ously, using multiple focus groups with data on each participant
collected via structured interview prior to the start of each discus-
sion.12 The study was conducted in Chicago IL and Atlanta GA
during April 2010. The methods were reviewed and approved by
Northwestern University, Emory University, and Grady Memorial
Hospital IRBs.
Subjects
Individuals were eligible to participate if they were aged ⬎18 years,
English-speaking, and without a severe visual, hearing or cognitive
impairment. Six focus groups were conducted with 45 participants
from three different sites. As patients with limited literacy are more
likely to have diffıculty reading and interpreting OTC medication
labels, populations expected to have a higher prevalence of limited
literacy were selected for the majority of the focus groups.
In Chicago, individuals were recruited by convenience sampling
from a private, university-based general internal medicine clinic
and a nonprofıt adult literacy and education program. In the clinic,
flyers were used to recruit interested individuals. At the adult
education program, teachers described the study to students and
referred those interested to a research coordinator. Finally, a con-
venience sample of individuals from one outpatient clinic in At-
lanta were approached and recruited while they were waiting for an
appointment. All individuals were screened for eligibility prior to
beginning the focus groups.
Focus Group Structure and Content
Prior to each focus group, structured, individual interviews were
conducted by a trained research assistant. The interview included
verbal consent followed by questions regarding attention and ad-
herence to OTC medication instructions, sociodemographics, and
an assessment of literacy using the Rapid Estimate of Adult Literacy
in Medicine (REALM).13,14 The two initial focus groups revealed
anecdotal evidence of gross misunderstanding of active ingredients
in many OTC products. Consequently, participants in the fınal
four groups were asked, in the individual interview, to match
images of name-brand, pain medicine box fronts to the main
ingredient in each medicine so as to quantitatively assess their
knowledge of active ingredients.
All six focus groups were led by two moderators using a semi-
structured guide developed by the research team. Questions
probed individuals’ thoughts about current OTC labels and under-
standing of “active ingredient,” and that overdose and potential
liver failure may result from taking OTC acetaminophen.
Handouts including warning messages about simultaneous use
of acetaminophen products and maximum dose were shown to
participants. The handouts included both current label wording
and alternative messages created by the research team, developed
using health literacy principles.10,15,16 Participants were asked
questions such as Looking at these messages—which is the most
helpful? Which is most clear? and Is it enough to say not to take
another medicine that has acetaminophen? Or is it important for you
to know why?
The process was repeated using handouts with a set of six icons
for identifying acetaminophen and separate handouts with six
icons for maximum daily dose. Participants were asked questions
such as Which icon do you like best? Why? and Do you think any of
these would make you more likely to look at the messages? All icons
were created by graphic artists as part of a separate, iterative re-
search process that included consumer feedback on color, shape,
clarity, and meaning. Bottles with example icons and messages
integrated into current Drug Facts labeling (FDA-required labeling
on all OTC drugs) also were shown and participants were asked,
How does the acetaminophen information on this bottle compare to
the current bottles we showed you at the beginning? Is it better? More
clear? All focus groups were audio-taped, and participants received
$40 in cash or a grocery store gift card as compensation for their
time.
Data Analysis
During debriefıng sessions immediately after each focus group,
broad themes were noted by research staff members who were
present during the focus groups. Audio tapes were transcribed
verbatim by research staff and reviewed for any additional themes
not previously noted. Codes identifying themes were created, re-
vised, applied to text sections using Atlas TI software, and queried
to identify patients’ remarks and opinions associated with each
code. Descriptive statistics (frequency, M, SD) were obtained for
the results of the one-on-one interviews. Analyses were conducted
from April to June 2010.
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 King et al / Am J Prev Med 2011;40(6):593–598 595
Table 1. Sociodemographic characteristics of focus group participants, % unless otherwise indicated

Literacy organization Public hospital

Characteristic Overall (N⫽45) Private clinic (n⫽12) (n⫽15) (n⫽18)

Age (years; M [SD]) 48.3 (12.7) 39.8 (14.4) 53.6 (11.7) 49.6 (9.6)
Female 51 58 53 44
Education
Less than high school 9 0 27 0
Some high school 36 0 60 39
High school graduate 18 0 13 33
Some college/college grad 38 100 0 28
Race
African-American 73 17 87 100
Caucasian 27 83 13 0.0
a
Income ($)
⬍10,000 44 8 60 56
10,000–24,999 27 8 33 33
25,000–50,000 7 17 0 6
⬎50,000 16 58 0 0
Health literacy level
Low (ⱕ6th grade) 44 8 73 44
Marginal (7th–8th grade) 20 0 20 33
Adequate (ⱖ9th grade) 36 92 7 22
a
Percentages do not sum to 100 because of don’t know/refused responses.

Results the focus group transcripts produced three large catego-

Characteristics of focus group participants are detailed in
Table 1. The groups were largely homogenous by site.
Nearly three-quarters of the participants were recruited
from the adult education program and the public teach-
ing hospital and tended to have a lower income and lower
literacy level.
Participants’ knowledge of active ingredients in
common OTC pain medicines, assessed at the begin-
ning of the individual interviews, varied from 75% to
19% (Table 2). Thirty-one percent correctly identifıed
acetaminophen as the active ingredient in Tylenol®.
Only 41% of participants indicated that they always look
at the active ingredient information when purchasing
OTC medicines. When asked, Before you take over-the-
counter pain medicines, how often do you read the instruc-
tions for use? with response options of always, often,
sometimes, rarely, or never, about half (48%) of partici-
pants indicated they always read the instructions. About
16% of participants specifıcally mentioned their prior
experience with taking OTC pain relievers as a reason for
failing to consistently read the directions. The analysis of
ries of responses: (1) understanding “active ingredient”;
(2) value of active ingredient icon; and (3) value of max-
imum daily dose icon.
Understanding “Active Ingredient”
Overall, participants demonstrated limited knowledge of
the concept of active ingredient. Some had heard of acet-
aminophen and ibuprofen but “couldn’t tell you the dif-
ference.” Few participants in the lower-literacy groups
had heard of acetaminophen. In general, patients paid
attention to the active ingredient in the medicine only if
they knew of a contraindication for one of their other
medicines, and relatively few participants mentioned this
as a factor.
Most participants, even those who had heard of acet-
aminophen, generally expressed surprise in learning that
acetaminophen, or what they knew as Tylenol, can cause
liver damage. While examining a current bottle of medi-
cine during the focus group, a participant commented, “I
have never noticed this before, where it says ‘do not use
with other medicines containing acetaminophen.’ And

June 2011
596 King et al / Am J Prev Med 2011;40(6):593–598
Table 2. Percentage of participants correctly identifying
active ingredient in common nonprescription pain
relieversa

Drug
name % correct (n⫽32)b Active ingredient

Bayer® 75 Aspirin
Motrin® 47 Ibuprofen
Tylenol® 31 Acetaminophen
Aleve® 19 Naproxen sodium
Advil® 19 Ibuprofen
Figure 2. (A, B) Most-preferred icons and (C) message for
All correct 6 maximum dose
a
Participants were shown images of the front panels of the boxes for
each of the medicines next to a list of active ingredients and
instructed to please name the active ingredient that goes with each
name brand medicine.
two products containing acetaminophen and include that
b
Only participants from final four focus groups completed this task. possible liver damage is the reason. The majority also felt
that liver damage would be easily understood by most
the warnings where it says that it could cause liver dam- people, and that liver damage was not a particularly com-
age in case of overdose.” In another group, after the plex medical term. “For people like us that can’t read well,
facilitator explained the potential for liver damage from we still all know ‘liver.’ I don’t know what easier term you
overdose, a participant responded, “I didn’t know that. could put in there.”
And I have taken a lot of Tylenol®.”

Value of Active Ingredient Icon Value of Maximum Daily Dose Icon

Participants liked having an icon to identify products
that contain acetaminophen: “I believe that this [icon]
is a good idea for those who can’t read or understand
what this big word [acetaminophen] is.” When given
examples of icons, most preferred a hexagon shape
enclosing “Ac” (Figure 1a) for identifying acetamino-
phen. Participants said that the shape drew their atten-
tion while also cueing them to be cautious. However,
several participants noted that unless there was consis-
tency and adoption of the same icon by all manufac-
turers of acetaminophen products, the use of the icon
would not be meaningful.
In the written message accompanying the icon, most
participants wanted the word acetaminophen to be high-
lighted (Figure 1b). All participants felt it was important
to explicitly state that it is not safe to simultaneously take
Figure 1. (A) Most-preferred icon and (B) warning message
for acetaminophen
Participants were in favor of using an icon to highlight the
maximum number of pills that can be safely taken in 1
day. “If you have something like this [icon], it draws your
eyes right there.” Most preferred Figure 2a because “the
stop sign indicates caution, stop” and “the red catches
your eye.” A few other participants preferred a second
design that had “Stop at 6” and “in 24 hours” (Figure 2b).
“That [icon] is pretty universal— everyone can under-
stand that one—‘Stop at 6 in 24 hours.’”
There was some variation in patients’ preference for
the message accompanying the icon. Several preferred
“Do not exceed 6 caplets in 24 hours unless directed by
a doctor” because they felt the phrase “unless directed
by a doctor” provided a secondary warning implying
that if you are still in pain after taking the maximum it
is important not only to stop but also to see the doctor.
Other participants indicated the phrase was superflu-
ous: “Your doctor is not going to recommend more, so
that is not necessary.” Some suggested that the extra
phrase may actually lead to individuals taking more
than the maximum: “You might think it is ok to just go
ahead and take one more until you can get a hold of
[the doctor].” In addition, the word exceed was consid-
ered by some to be diffıcult to understand and pro-
nounce. Most participants wanted to keep it “clear,
simple, straight to the point” preferring the statement
“Do not take more than 6 pills in 24 hrs” (Figure 2c).

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 King et al / Am J Prev Med 2011;40(6):593–598
Discussion
Despite regulations in place since 1999, which require
active ingredient information to be listed fırst in Drug
Facts on all OTC products,6 the present study found that
few participants knew acetaminophen is the active ingre-
dient in Tylenol. Poor recognition of which products,
both OTC and prescription, contain acetaminophen is
not uncommon and has been found in other studies17,18
among patients seeking medical attention for a complaint
of pain. Americans commonly identify OTC pain reliev-
ers by brand name rather than generic (or active ingredi-
ent) name.19 Recognition of the brand name instead of
the active ingredient has the potential for serious conse-
quences for consumers with the large number of products
containing acetaminophen available today yet marketed
under different brand names.
The fınding that many individuals self-reported fail-
ing to routinely look at OTC labeling presents a chal-
lenge to OTC manufacturers in communicating risks
and instructions to ensure the safe use of their prod-
ucts. Several participants offered prior experience with
the medicine as a reason for failing to read labeling,
indicating that new information appearing on the label
has to be unique or appear different to draw their
attention. Icons, in particular, may hold promise as
visual aids to attract consumer attention to key active
ingredient, risk, and maximum dose information lo-
cated on text-heavy product labels.
Prior studies have emphasized the benefıt of designing
icons to increase attention to key medication information
as well as to improve patient comprehension. Webb and
colleagues12 applied a patient-centered approach similar
to this study to develop auxiliary warning icons and mes-
sages for prescription labels. The icons were found to
improve attentiveness and comprehension, with the
greatest improvement seen among consumers with lower
levels of literacy.10 To our knowledge, a similar process to
develop icons for OTC medications has not been per-
formed. In this study, icons preferred by consumers for
identifying acetaminophen and its maximum daily dose
in products were identifıed.
Study limitations include the inclusion of only English-
speaking individuals because of criteria for the REALM
assessment. In the U.S., there is limited availability of
OTC packaging in languages other than English. Future
studies should evaluate the effıcacy of these icons among
consumers with limited English profıciency. In addition,
although it is acknowledged that the results of this study
may not be generalizable because of the high proportion
of individuals with low literacy levels, it was felt that
gaining input from this population is important, as pa-
tients with limited literacy are more likely to have diffı-
June 2011
597
culty interpreting OTC labels. Finally, this study de-
scribes only the development and not the testing of
potential patient-centered icons and messages for
acetaminophen.
With the high prevalence of OTC medication use, it is
possible a large number of adults will greatly benefıt from
the use of simple, explicit messages and icons as a more
effıcient manner of identifying acetaminophen medica-
tions and their maximum dose. Additionally, partner-
ships among health services researchers, industry, and
government should be formed to identify optimal ways to
improve product labeling and educate the public on the
meaning of icons and the importance of safe use of these
medicines.
This work was supported by an unrestricted research grant
from McNeil Consumer Healthcare. The funder did not
contribute to the study design, data collection, or interpre-
tation of fındings. Rather, discussions with the investigators
and funder were held primarily on implications of fındings,
not on the decision to publish or prohibit the release of any
data.
JPK has worked on projects funded by unrestricted re-
search grants from McNeil Consumer Healthcare. TCD has
received unrestricted research grant funding from McNeil
Consumer Healthcare and Abbott Foundation, and has
served as a paid consultant to McNeil Consumer Healthcare
and Abbott Laboratories. She owns stock in Pfızer, Abbott,
and Johnson & Johnson. SCB has worked on an unrestricted
research grant funded by McNeil Consumer Healthcare and
has served as a paid consultant to Abbott Laboratories. RMP
has received unrestricted research grant support from Mc-
Neil Consumer Health, Johnson & Johnson, Abbott Founda-
tion, and McKing Consulting. None of this support is a
source of a conflict of interest. MSW has received unre-
stricted research grant funding from McNeil Consumer
Healthcare and Abbott Foundation, and has served as a paid
consultant to McNeil Consumer Healthcare, Abbott Labora-
tories and Earthbound LLC.
No other fınancial disclosures were reported by the authors
of this paper.
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