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Cough and Cold Medication Use by US Children, 19992006: Results From the

Slone Survey
Louis Vernacchio, Judith P. Kelly, David W. Kaufman and Allen A. Mitchell
Pediatrics 2008;122;e323
DOI: 10.1542/peds.2008-0498

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ARTICLE

Cough and Cold Medication Use by US Children,


1999 2006: Results From the Slone Survey
Louis Vernacchio, MD, MSc, Judith P. Kelly, MS, David W. Kaufman, ScD, Allen A. Mitchell, MD
Slone Epidemiology Center, Boston University, Boston, Massachusetts
Financial Disclosure: The analyses presented in this article were funded internally by the Slone Epidemiology Center at Boston University; the center has received funding from McNeil Consumer Healthcare for
other analyses related to the pediatric use of cough and cold medications.

Whats Known on This Subject

What This Study Adds

Pediatric OTC CCMs are readily available in the United States and are widely promoted
for the treatment of childrens upper respiratory tract infections. Recent reports have
linked these products to serious adverse effects and deaths among children.

This study documents the prevalence and patterns of use of CCMs among US children
and provides a baseline against which to measure any changes in use that occur as a
result of marketing or regulatory actions.

ABSTRACT
OBJECTIVE. Pediatric cough and cold medications are widely marketed in the United States,
but the precise patterns of use among children are not known. Such information is
especially important given recent reports suggesting that these medications are responsible for previously underappreciated serious adverse events and deaths among children.
We sought to describe the prevalence and patterns of pediatric use of cough and cold
medications, with particular attention to use among young children.
METHODS. We analyzed data on the use of cough and cold medications, defined as any
oral medication that contains 1 antitussive, decongestant, expectorant, and/or
first-generation antihistamine active ingredients, among 4267 US children who were
younger than 18 years and enrolled during 1999 2006 in the Slone Survey, a
national random-digit-dial telephone survey of medication use by the US population.
RESULTS. In a given week, a cough and cold medication was used by 10.1% of US

www.pediatrics.org/cgi/doi/10.1542/
peds.2008-0498
doi:10.1542/peds.2008-0498
Key Words
cough and cold medications,
over-the-counter medications
Abbreviations
CCM cough and cold medication
OTC over-the-counter
FDAFood and Drug Administration
CI condence interval
Accepted for publication Apr 16, 2008
Address correspondence to Louis Vernacchio,

children. Exposure was highest to decongestants (6.3%; mostly pseudoephedrine)


MD, Slone Epidemiology Center at Boston
University, 1010 Commonwealth Ave, Boston,
and first-generation antihistamines (6.3%; most common were chlorpheniramine,
MA 02115. E-mail: lvernacchio@slone.bu.edu
diphenhydramine, and brompheniramine), followed by antitussives (4.1%; mostly
PEDIATRICS (ISSN Numbers: Print, 0031-4005;
dextromethorphan) and expectorants (1.5%; almost exclusively guaifenesin). MulOnline, 1098-4275). Copyright 2008 by the
tiple-ingredient products accounted for 64.2% of all cough and cold medications
American Academy of Pediatrics
used. Exposure to antitussives, decongestants, and first-generation antihistamines
was highest among 2- to 5-year-olds (7.0%, 9.9%, and 10.1%, respectively) followed by children who were younger
than 2 years (5.9%, 9.4%, and 7.6%, respectively); expectorant use was low in all age groups. The use of cough and
cold medications declined from 1999 through 2006.
CONCLUSIONS. Approximately 1 in 10 US children uses a cough and cold medication in a given week. The especially high
prevalence of use among children of young age is noteworthy, given concerns about potential adverse effects and the
lack of data on the efficacy of cough and cold medications in this age group. Pediatrics 2008;122:e323e329

EDIATRIC COUGH AND cold medications (CCMs), which typically include antitussives, decongestants, expectorants,
and/or first-generation antihistamines, are readily available over the counter (OTC) in the United States and are
widely promoted for the treatment of childrens upper respiratory tract infections. Many of these medications are also
approved for the treatment of allergic diseases and may be used for those conditions as well. Reports of adverse effects
that are associated with these products (particularly inadvertent overdose) have increased in recent years, especially
among very young children. For example, the Toxic Exposure Surveillance System documented nearly 90 000 calls
and 3 accidental deaths associated with CCM among US children in 2004,1 and 7000 annual emergency department
visits were attributed to CCM in a recent study.2 Among children who were younger than 2 years, the Centers for
Disease Control and Prevention linked CCMs to 1500 emergency department visits in 2004 2005 and 3 additional
deaths in 2005.3 The US Food and Drug Administration (FDA) recently enforced measures against unapproved
marketing of the antihistamine carbinoxamine to young children because of reports of 21 deaths that were associated
with use of this drug in children who were younger than 2 years.4 In a number of case series, CCM overdoses have
been linked to neurologic impairment, cardiovascular instability, and death among young children.59
Concerns about these toxicities, especially in light of data that CCMs have not been proved effective in treating
symptoms of cough and the common cold in young children,1016 led to the filing of a citizen petition with the FDA

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on March 1, 2007,17 which prompted an FDA review of


the safety and efficacy of CCMs for children. In October
2007, the Consumer Healthcare Products Association
announced a voluntary withdrawal of infant cough
and cold preparations targeted to children who are
younger than 2 years.18 In the meantime, the FDAs
Nonprescription Drugs and Pediatric Advisory committees voted to ban OTC CCMs that are intended for children who are younger than 6 years,19 and the FDA is
currently considering the committees advice.
Although the potential for harm has been documented, understanding the risks of CCMs to children
requires information on the prevalence and patterns of
use of these medications. It is difficult, however, to identify usage patterns for what are primarily OTC products.
Unlike prescription drugs, purchases of OTC medications
are not captured in insurance and pharmacy claims data;
in addition, data on patterns of exposure can be obtained
only directly from patients or their parents. As a result,
very few data exist on the prevalence and patterns of
CCM use among children. One US study from 1994,
relying on interview data from the Longitudinal Follow-up to the National Maternal and Infant Health Survey, found that approximately one third of 3-year-old
children had used an OTC CCM within the previous 30
days,20 and a 2007 study from England based on mail
survey data from the Avon Longitudinal Study of Parents and Children identified use of CCMs in the previous
year by two thirds of children 3.0 to 4.5 years of age and
by approximately half of children 5.5 to 7.5 years of
age.21 A national telephone survey conducted in November 2007 reported that 56% of parents of children who
were younger than 2 and 79% of parents of children
who were aged 2 to 6 years had ever given their children
a CCM, but no additional information on types of products or patterns of use was collected22; therefore, to
characterize the current prevalence and patterns of use
of CCMs by US children and to provide a baseline against
which to measure any changes in use that occur as a
result of marketing and regulatory actions, we analyzed
data from the Slone Survey, a random-digit-dial telephone survey of medication use among the US population.
METHODS
Detailed methods of the Slone Survey have been published.23 Briefly, this random-digit-dial telephone survey
targeted households in the 48 contiguous states and the
District of Columbia and was conducted continuously
between February 1998 and April 2007. Once a household was successfully contacted, 1 individual from the
household was randomly selected for interview and informed consent was obtained. All medication use (including prescription and OTC products, vitamins/minerals, and herbals/supplements) by the selected individual
within the past week was ascertained by structured interview. Medications were linked to their active ingredients through the Slone Epidemiology Centers Drug
Dictionary.24 Details of use were obtained, including
drug form (eg, tablet, liquid), duration and frequency of
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VERNACCHIO et al

use, and reason for use. For children who were younger
than 14 years, a parent/guardian was interviewed; for
children who were 14 to 17 years of age, either the child
or a parent/guardian was interviewed (82.2% of interviews in this age range were completed by a parent/
guardian). The study was approved by the Boston University Medical Campus Institutional Review Board.
This analysis used data derived from all individuals
who were younger than 18 years for the complete years
1999 2006. We included in the analysis all oral medications, both OTC and prescription, that contained 1
antitussive, decongestant, expectorant, or first-generation antihistamine active ingredients (we excluded firstgeneration antihistamines such as dimenhydrinate and
cyproheptadine that do not carry an indication for the
common cold). Response rates were calculated according to the American Association for Public Opinion Research RR3 definition.25 Estimates of the weekly prevalences of use were weighted by household size to adjust
for the probability of selection. Prevalence comparisons
were performed by 2 analysis. SAS 9.1 (SAS Institute,
Cary, NC) was used for all analyses.
RESULTS
The response rate to the survey during the period 1999
2006 was 61.9%, and 4267 individuals who were aged 0
to 17 years were enrolled. The median age was 9 years
(25th, 75th percentiles: 4, 13), and 48.9% were female
(both similar to the 2000 US census26). In terms of race/
ethnicity, 65.2% were white non-Hispanic (69.1%, census); 14.3% were Hispanic (12.5%, census); 11.7% were
black non-Hispanic (12.1%, census); 1.9% were Asian
non-Hispanic (3.6%, census); and 7.0% were of other,
mixed, or unknown race/ethnicity (2.7%, census). According to US census regions, 19.4% were from the
Northeast (18.0%, census), 25.9% from the South
(35.4%, census), 25.0% from the Midwest (23.1%, census), and 29.8% from the West (23.5%, census).
Of the 4267 children surveyed, 439 had used a CCM
in the previous week, for a weighted prevalence of use of
10.1% (95% confidence interval [CI]: 9.211.0). The
1-week prevalences of exposure to specific CCM active
ingredients are shown in Table 1; 4.1% of individuals
were exposed to antitussives (primarily dextromethorphan), 6.3% to decongestants (primarily pseudoephedrine), 1.5% to expectorants (nearly all guaifenesin), and
6.3% to a variety of first-generation antihistamines.
A summary of the 489 products used by the 439 study
subjects is shown in Table 2. Among those products, 175
(35.8%) were single-ingredient products, the most common of which were first-generation antihistamines
(19.4% of all products) and decongestants (7.2%). A total
of 314 (64.2%) products contained multiple active ingredients; those most commonly used were decongestant/
first-generation antihistamine combinations (15.5%) and
antitussive/decongestant/first-generation antihistamine
combinations (10.4%). Of note, 100 (20.4%) of the
CCM products also contained an analgesic (acetaminophen, in all but 7). We asked the reason for the use of
each medication, but many responses were not clearly

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TABLE 1 One-Week Prevalence of Exposure to Any CCM, Categories


of Active Ingredients, and Specic Active Ingredients
Among 4267 US Children: 1999 2006
Parameter

Weighted Prevalence,
% (95% CI)a

Any CCMb
Antitussives
Dextromethorphan
Codeine
Hydrocodone
Carbetapentane
Decongestants
Pseudoephedrine
Phenylpropanolamine
Phenylephrine
Expectorants
Guaifenesin
Guaiacolsulfate
First-generation antihistamines
Chlorpheniramine
Diphenhydramine
Brompheniramine
Doxylamine
Carbinoxamine
Pyrilamine
Promethazine
Hydroxyzine
Phenyltoxamine
Triprolidine
Pheniramine
Dexbrompheniramine
Phenindamine

439
174
161
8
4
1
278
214
53
21
68
67
1
271
99
83
50
14
10
9
8
5
4
3
2
1
1

10.1 (9.211.0)
4.1 (3.54.7)
3.8 (3.24.4)
0.2 (0.10.4)
0.1 (0.00.2)
0.0 (0.00.1)
6.3 (5.67.1)
4.9 (4.25.6)
1.1 (0.81.4)
0.5 (0.30.7)
1.5 (1.11.9)
1.5 (1.11.8)
0.0 (0.00.1)
6.3 (5.57.0)
2.2 (1.82.6)
2.0 (1.52.4)
1.1 (0.81.5)
0.4 (0.20.6)
0.3 (0.10.4)
0.2 (0.10.3)
0.2 (0.00.3)
0.1 (0.00.2)
0.1 (0.00.2)
0.1 (0.00.1)
0.1 (0.00.1)
0.0 (0.00.1)
0.0 (0.00.1)

a Weighted

for household size


as an oral medication that contains 1 antitussive, decongestant, expectorant, or
rst-generation antihistamine active ingredients.

b Dened

related to cough, cold, or allergy (eg, sleep, pain) or


were difficult to classify specifically (eg, runny nose,
congestion, sinus). For the 489 products used, the
stated reason for use was cough in 116 (23.7%); cold in
106 (21.7%); allergy in 96 (19.6%); and not related to
cough, cold, or allergy or unclear in 171 (35.0%). The
forms of the products used stratified by age are shown in
Fig 1. Among children who were younger than 2 years,
94.6% were liquid preparations, a frequency that decreased with age to 23.3% among adolescents.
The 1-week prevalences of use of specific active ingredients stratified by age are shown in Fig 2. Exposure
to antitussives, decongestants, and first-generation antihistamines was highest among 2- to 5-year-olds (7.0%,
9.9%, and 10.1%, respectively) followed by children
who were younger than 2 years (5.9%, 9.4%, and 7.6%,
respectively). Expectorant use was relatively low in all
age groups.
Among all ages combined, the 1-week prevalence of
use of any CCM declined significantly throughout the
course of the study, from a high of 12.3% in 1999 2000
to a low of 8.4% in 20052006 (P .003 for trend; Fig
3). The prevalence of exposure to antitussive and expectorant active ingredients did not change significantly
over time (P .3 and P .2 for trend, respectively). In
contrast, decongestant use declined from 7.2% in 1999
2000 to 5.1% in 20052006 (P .03 for trend), with a
steep decline in phenylpropanolamine use, from 2.8% in
1999 2000 to 0.3% in 20052006 (P .0001 for trend).
In addition, first-generation antihistamine use declined
from 8.5% in 1999 2000 to 5.3% in 20052006 (P
.002 for trend). The use of antihistamines did not vary
significantly according to season, but antitussives, de-

TABLE 2 List of 489 Cough and Cold Product Types Used by 439 Study Subjects
Product Type

n (%) of All
Products

First-generation antihistamine
Decongestant rst-generation antihistamine
Antitussive decongestant rst-generation antihistamine
Antitussive decongestant rst-generation antihistamine analgesic
Decongestant
Antitussive expectorant
Decongestant analgesic
Antitussive
Expectorant
Decongestant second-generation antihistamineb
Antitussive decongestant
Decongestant rst-generation antihistamine analgesic
Antitussive decongestant analgesic
Antitussive decongestant expectorant
First-generation antihistamine analgesic
Decongestant expectorant
Antitussive rst-generation antihistamine
Antitussive analgesic
Antitussive decongestant expectorant analgesic
Antitussive decongestant expectorant rst-generation antihistamine
Expectorant rst-generation antihistamine

95 (19.4)
76 (15.5)
51 (10.4)
36 (7.4)
35 (7.2)
28 (5.7)
24 (4.9)
23 (4.7)
22 (4.5)
20 (4.1)
18 (3.7)
17 (3.5)
9 (1.8)
8 (1.6)
8 (1.6)
7 (1.4)
4 (0.8)
4 (0.8)
2 (0.4)
1 (0.2)
1 (0.2)

Reason for Usea


Cough

Cold

Allergy

Other

4
15
21
10
1
22
2
10
11
0
7
1
2
5
0
2
2
0
0
0
1

3
25
14
13
8
2
7
6
6
1
8
4
6
0
0
0
2
0
1
0
0

52
15
3
0
3
1
1
0
0
17
0
3
0
0
0
0
0
0
0
1
0

36
21
13
13
23
3
14
7
5
2
3
9
1
3
8
5
0
4
1
0
0

a Reason for use was reported by the patient or parent; other includes responses that were not specically related to cough, cold, or allergy (eg, sleep, pain), or were difcult to classify specically
(eg, runny nose, congestion, sinus).
b Indicated for allergic diseases only, not common cold.

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100%

2.7%
2.7%

0.7%

7.6%

Other/unknowna
Tablet/capsule
Liquid

2.3%

0.7%

90%
33.8%

80%
70%

74.4%

60%
50%

94.6%

91.7%

40%
65.4%

30%
20%

23.3%

10%
0%
<2 y

25 y

611 y

1217 y

FIGURE 1
Form of cough and cold products used by children, stratied according to age group.

congestants, and expectorants each were used less frequently in the summer and more frequently in the winter (data not shown).
We examined the overall use of CCM stratified by the
childs gender and race/ethnicity, parental education,
household income, census region, and household size
and found no appreciable differences (data not shown),
except for a borderline higher prevalence of use among
individuals from the South and Midwest compared with

the Northeast (odds ratio for South: 1.5 [95% CI: 1.1
2.0]; odds ratio for Midwest: 1.5 [95% CI: 1.12.0]).
We also examined the duration of use of CCMs on at
least 1 day per week among study subjects. As shown in
Fig 4, the majority of CCM use was for 1 week. For
antitussives and expectorants, 15% of use was for 1 to
4 weeks, with virtually no use lasting 4 weeks. In
contrast, 22.9% of first-generation antihistamine use
was for 1 week (including 12.2% for 4 weeks), and

12%
Under 2 years
2-5 years

10%

6-11 years
12-17 years

8%

6%

4%

2%

0%
Antitussives

Decongestants

Expectorants

First-generation
antihistamines

FIGURE 2
Prevalence of exposure to antitussive, decongestant, expectorant, and rst-generation antihistamine active ingredients according to age group. Bars represent 95% CIs.

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VERNACCHIO et al

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14%
12%
Any cough/cold
medication
Antitussives

10%
8%
FIGURE 3
Prevalence of exposure to any CCM and specic active
ingredients according to 2-year intervals.

Decongestants

6%

Expectorants

4%

First-generation
antihistamines

2%
0%
1999-2000

22.5% of decongestant use was for 1 week (including


10.4% for 4 weeks). Of the 56 individuals who used a
CCM for 4 weeks, 22 used a first-generation antihistamine alone, 14 used a decongestant plus a secondgeneration antihistamine, and 9 used a decongestant
plus a first-generation antihistamine; the majority took
them on a daily basis. The reasons for using a CCM for
4 weeks included allergies in 37 (66.1%), sleep in 4
(7.1%), cough in 2 (3.6%), cold in 1 (1.8%), and other
reasons in 12 (21.4%). Among those who took a CCM
for 4 weeks, there were 11 children who were younger
than 6 years. Four of them used a first-generation antihistamine alone; 4 used a decongestant plus first-gener-

>4 wk, 1.1%

>4 wk, 10.4%

14 wk,
14.3%

14 wk,
12.1%

1 wk,
77.5%
1 wk,
84.6%

>4 wk, 12.2%

>4 wk, 1.5%

14 wk,
10.8%

14 wk,
14.9%

1 wk,
77.1%
1 wk,
83.6%

FIGURE 4
Duration of use on at least 1 day per week for antitussive (A), decongestant (B), expectorant (C), and rst-generation antihistamine (D) active ingredients.

2001-2002

2003-2004

2005-2006

ation antihistamine; and 1 each used a decongestant


alone, a decongestant plus a second-generation antihistamine, and a first-generation antihistamine plus an analgesic.
DISCUSSION
This study documents that CCMs are used widely by US
children for the treatment of coughs, colds, allergies, and
a variety of other reasons, with 1 in 10 children, or just
over 7 million individuals, exposed to at least 1 CCM in
a given week. Our estimate of the weekly prevalence of
exposure is consistent with a monthly prevalence of
approximately one third among 3-year-olds in the only
other published US study to examine this issue.20 We
found exposure to be particularly high among young
children, raising a potential safety concern because
nearly all published reports of CCM-associated serious
adverse events and deaths have involved very young
children.1,39 Although the high prevalence of use together with the relatively small number of reported serious adverse events may suggest that the absolute magnitude of risk associated with pediatric CCM use is small,
the important clinical and public health question is
whether any serious risk is justified by the benefits of
treatment. Despite widespread parental belief that pediatric CCMs are effective for treating coughs and colds,22
there are no data supporting the efficacy of CCMs for
such uses in young children; the few available randomized, controlled trials have found no significant benefits
in this age group.1016
In addition to lack of evidence of efficacy for cough
and the common cold, CCM use in young children is
fraught with the potential for dosing errors. First, because of the lack of clinical and pharmacologic studies of
children, most pediatric dosages are extrapolated from
adult data, and many CCMs lack formal dosing recommendations for young children.27,28 Second, concentrations and dosages for young children are not standardized across products, dosage delivery devices differ from
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ents can have similar names. Finally, as our data point


out, well over half of pediatric CCM use involves multiple-ingredient products (with as many as 5 separate
active ingredients), a situation that increases the risk for
a child inadvertently receiving 1 product with the
same active ingredient.
The prevalence of use of any CCM among children
declined somewhat over the years of the study, with the
decline most notable for decongestants and first-generation antihistamines. The decline in decongestant use
seems largely attributable to the removal of phenylpropanolamine from the market in 2000 2001 because of
its association with hemorrhagic stroke in adults.29 We
speculate that pseudoephedrine use may likewise decline in the coming years as a result of the 2005 Combat
Methamphetamine Act, which requires pseudoephedrine-containing products to be kept behind pharmacy
counters.30 More broad, the prevalence and patterns of
pediatric CCM use are likely to change substantially
given the media attention being paid to the issue of CCM
safety, the Consumer Healthcare Products Associations
voluntary recall of CCMs that are marketed for children
who are younger than 2 years,18 and any regulatory
changes that the FDA may make in response to its advisory panels recommendations. It will be important to
track secular trends in pediatric CCM use as these
changes take effect.
Not surprising, we found that the duration of use of
CCMs varies substantially by components. Antitussives
and expectorants are used almost exclusively for brief
periods of time, whereas decongestants and first-generation antihistamines are more commonly used for extended durations. Most long-term use is for allergic diseases, and the predominant products used long-term are
antihistamines or decongestant-antihistamine combinations, which are indicated for allergies as well as the
common cold. Still, we identified a small number of
children, including a few who were younger than 6
years, who were given other combination CCMs regularly for extended periods of time, and the risks that are
associated with such long-term exposure are unknown.
Our data suggest that CCM use is not strongly associated with personal and demographic factors such as
gender, race/ethnicity, region, parental education,
household income, or household size. That use is so
widespread among US children suggests that efforts focused on educating the public about safe use of CCMs
should be broadly targeted.
Our study has several potential imitations. First, there
is the possibility of response bias. Although our response
rate was relatively high for a random telephone survey
and our distributions of age, gender, and race/ethnicity
approximate the 2000 US census data, our sample somewhat underrepresents children from the South and
overrepresents those from the West. We cannot determine whether CCM exposure among nonresponders or
undersampled populations differs from that of survey
participants. A second potential limitation is the accuracy of the drug exposure information collected in the
survey. We relied on parent (or patient) reports of products used, but we made significant efforts to ensure that
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VERNACCHIO et al

such information was compete and accurate. Individuals


were asked to gather all relevant bottles and packages
and to read medication names directly from the label;
these were matched in real time to drug codes from the
Slone Epidemiology Center Drug Dictionary, an electronic compendium of prescription, OTC, vitamin, and
herbal/supplement medications.24 Because only very recent use (within the previous 7 days) was elicited, the
possibility of recall errors was reduced. In most cases,
parents acted as reporters of their childrens medication
use, which may have led to underreporting of use in
adolescents who may have obtained and used CCMs
independently. Finally, our survey was not designed to
capture illicit drug use or intentional misuse.
CONCLUSIONS
This study demonstrates that CCM use is common
among US children despite a lack of demonstrated efficacy for treatment of cough and the common cold. Of
particular concern are high rates of exposure among
young children, for whom dosing recommendations are
largely extrapolated from adults and the risk for adverse
events is greatest. Regulatory changes (which are currently under consideration by the FDA) as well as efforts
aimed at educating parents and caregivers about the safe
use of CCMs may be needed to reduce inappropriate
exposure to these medications and thereby minimize
risks to children.
ACKNOWLEDGMENTS
We greatly appreciate the contributions of Theresa
Anderson, study coordinator; Marie Berarducci and
Marilyn Wasti, study supervisors; Gene Sun, information systems; and the interviewing staff.
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PEDIATRICS Volume 122, Number 2, August 2008

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e329

Cough and Cold Medication Use by US Children, 19992006: Results From the
Slone Survey
Louis Vernacchio, Judith P. Kelly, David W. Kaufman and Allen A. Mitchell
Pediatrics 2008;122;e323
DOI: 10.1542/peds.2008-0498
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