Department www.jpedhc.

org

Pharmacology Continuing Education

Section Editors
Teri Woo, MS, RN, CPNP
Pharmacology of
University of Portland
School of Nursing, Kaiser
Permanente, Portland,
Cough and Cold
Oregon
Elizabeth Farrington,
PharmD, FCCP, BCPS
Medicines CE

University of North Carolina,

School of Pharmacy and Teri Woo, MS, RN, CPNP
North Carolina Children’s
Hospital

OBJECTIVES
After reading this manuscript, the reader should be able to:
1. Describe the mechanism of action for commonly prescribed decongestants,
cough suppressants, expectorants, antihistamines, and antipyretics.
2. State FDA dosing recommendations for the use of cough and cold medications
for children less than 2 years of age.
3. List five infant cough and cold products that have been voluntarily withdrawn
from the market.
4. State five non-pharmacologic interventions parents can implement to provide
symptom relief for cough and cold symptoms.
5. Identify risks related to multiple ingredient products and multiple caregiver
administration.

A New York Times headline runny nose, congestion, cough,

Teri Woo is Instructor, University of
Portland School of Nursing, and
Pediatric Nurse Practitioner, Kaiser
Permanente, Portland, Ore.
Correspondence: Teri Woo, MS, RN,
CPNP, University of Portland School of
Nursing, 5000 N Willamette Blvd,
Portland, OR; e-mail: woot@up.edu.
J Pediatr Health Care. (2008). 22, 73-79.
0891-5245/$34.00
Copyright © 2008 by the National Asso-
ciation of Pediatric Nurse Practitioners.
doi:10.1016/j.pedhc.2007.12.007
reads, “F.D.A. Panel Urges Ban on
Medicine for Child Colds” (Harris,
2007). Suddenly the use of cough
and cold medicines in children is
the lead story on every news chan-
nel. This month’s column will fo-
cus on the pharmacology, safety,
and effectiveness of common over-
the-counter (OTC) cough and cold
medications in infants and children.
Commonly available OTC
cough and cold medications con-
tain either singly or in combination
a decongestant, cough suppres-
sant, antihistamine, expectorant,
and antipyretic. Parents administer
cough and cold medications to
provide temporary relief from the
symptoms of upper respiratory in-
fections in children, including
and fever.
DECONGESTANTS
The decongestants found in chil-
dren’s OTC cold medication are ei-
ther pseudoephedrine or phenyl-
ephrine. Systemic decongestants are
adrenergic receptor agonists (sym-
pathomimetics) that produce vaso-
constriction within the mucosa of
the respiratory tract, temporarily re-
ducing the swelling associated with
inflammation of the mucous mem-
branes. Sympathomimetic drugs
work on the ␣ receptors in the vas-
cular smooth muscle causing vaso-
constriction and pressor effects and
on the ␤-adrenergic receptors in the
heart causing increased heart rate
and force of contraction. Because of

Journal of Pediatric Health Care March/April 2008 73


The use of isotonic saline nose drops and gentle
aspiration can be effective in the temporary
relief of nasal obstruction in infants.
the cardiac effects, these agents
should be used with caution in chil-
dren with congenital heart disease,
hypertension, or cardiac arrhyth-
mias without consulting the patient’s
pediatric cardiologist. Pseudo-
ephedrine (Sudafed) and phenyl-
ephrine (Sudafed PE) may have
mild central nervous system (CNS)
stimulant effects in patients sensitive
to sympathomimetics. Oral decon-
gestants also should be used with
caution in patients with hyperthy-
roidism and diabetes mellitus.
Topical decongestant products
are applied topically to the nasal
tissues via spray or drops. Topical
decongestants stimulate the ␣-ad-
renergic receptors in the arterioles
of the nasal mucosa, leading to va-
soconstriction and shrinkage of na-
sal tissues. There is minimal sys-
temic absorption if used as
directed. Therapy should not ex-
ceed 3 to 5 days because of the
development of rebound conges-
tion with ␣-adrenergic receptor
agents. If congestion persist, nor-
mal saline nose drops may be sub-
stituted for the vasoactive drugs for
3 to 5 days, then another trial of
active drug may be attempted if
necessary. Two topical deconges-
tants currently are available OTC in
the United States: phenylephrine
(Neo-Synephrine) and oxymetazo-
line (Afrin).
The use of isotonic saline nose
drops and gentle aspiration can be
effective in the temporary relief of
nasal obstruction in infants. Also
useful is the general humidification
of room air. Moisture tends to di-
lute tenacious nasal mucus so that
it is easier to remove.
COUGH SUPPRESSANTS
Dextromethorphan is the cough
suppressant found in OTC cough
74 Volume 22 • Number 2
medications, and it often is com-
bined with the expectorant guai-
fenesin. Dextromethorphan, the D
isomer of the codeine analogue
levorphanol, acts centrally in the
cough center in the medulla to
suppress cough. Drowsiness, diz-
ziness, nausea, and gastrointestinal
upset also may be seen with dex-
tromethorphan use.
Diphenhydramine, an antihista-
mine, also is marketed as a cough
suppressant for children (Pedia-
Care Children’s Long-Acting Cough).
The exact mechanism of action of
first-generation antihistamines an-
titussive effects is unknown, al-
though it is thought that the CNS
depression effects of first-genera-
tion antihistamines may depress
respiratory reflexes, thus suppress-
ing cough (McLeod et al., 1998).
EXPECTORANTS
Guaifenesin is the most com-
monly prescribed oral mucolytic
agent as an expectorant in the
United States. Its mechanism of ac-
tion is to reduce the surface ten-
sion and viscosity of the mucus,
which increases the ease of expec-
toration. Respiratory mucus re-
moval is facilitated by increased
flow of the thinned secretions via
ciliary action. Studies on the effi-
cacy of guaifenesin have failed to
demonstrate either improved pul-
Studies on the efficacy of guaifenesin have
failed to demonstrate either improved
pulmonary function or decreased sputum
viscosity. Hence, its clinical usefulness is
questionable.
monary function or decreased spu-
tum viscosity. Hence, its clinical
usefulness is questionable.
ANTIHISTAMINES
Diphenhydramine, chlorphe-
niramine, and brompheniramine
are the antihistamines found in
children’s cold and allergy formu-
las. Antihistamines, also known as
H1 receptor antagonists, compete
for and block the action of hista-
mine at the H1 receptor site on
cells in the respiratory tract, gastro-
intestinal tract, and blood vessels.
In the respiratory tract, antihista-
mines decrease congestion related
to allergies.
Naclerio and colleagues (1988)
studied the response of inflamma-
tory mediators to induced viral in-
fections. All variables except hista-
mine grew stronger in direct
relationship with the symptoms as
the cold increased in severity. This
finding indicates that antihistamines
have no role in the treatment of the
common cold; they will not shorten
the period of symptoms. They are
helpful, however, in the treatment of
the symptoms of allergic rhinitis.
Lastly, in young infants, sympatho-
mimetic-antihistamine mixtures are
particularly dangerous because they
may cause respiratory depression.
ANTIPYRETICS
Some multi-symptom cold for-
mulas contain acetaminophen or
ibuprofen as an antipyretic and
analgesic. Acetaminophen acts cen-
trally to inhibit the synthesis prosta-
glandins in the CNS and peripherally
to block pain impulse generation.
Antipyretic activity is due to its ac-
Journal of Pediatric Health Care
tion against prostaglandin E2 in the
CNS, which increases in fever
(Aronoff & Neilson, 2001). Ibupro-
fen is a cyclo-oxygenase (COX) en-
zyme inhibitor. COX is needed for
prostaglandin synthesis, and inhibit-
ing COX leads to antipyretic activity
because of decreased prostaglandin
E synthesis in the CNS.
LACK OF EVIDENCE FOR
EFFECTIVENESS OF COUGH
AND COLD MEDICATIONS IN
CHILDREN
Evidence is lacking for the ef-
fectiveness of cough and cold
medications in children. A recent
Cochrane review of the use of de-
congestants to treat nasal conges-
tion associated with the common
cold found a small (6%) but statis-
tically significant improvement in
congestion in adults (Taverner &
Latte, 2007). The review found in-
sufficient evidence in the literature
regarding the effectiveness of de-
congestants to treat the common
cold in children and recom-
mended that decongestants not be
used in children younger than 12
years (Taverner & Latte). A Co-
chrane review of the use of cough
medications for acute cough in
children found a lack of evidence
for the use of OTC cough medica-
tions in children, including antitus-
sives, expectorants, and antihista-
mines (Schroeder & Fahey, 2004).
The American College of Chest
Physicians evidence-based prac-
tice guidelines note limited effi-
cacy of cough suppressants in pa-
tients with cough due to the
common cold and do not recom-
mend the use of cough suppres-
sants for upper respiratory infec-
tions (Bolser, 2006). This guideline
is consistent with the American
Academy of Pediatrics (AAP) pol-
icy, which states there are no well-
controlled scientific studies regard-
ing the efficacy and safety of
antitussives in children (AAP Com-
mittee on Drugs, 1997).
Journal of Pediatric Health Care
SAFETY OF OTC COUGH
AND COLD MEDICATIONS IN
INFANTS AND CHILDREN
Concerns regarding the safety
of cough and cold medications can
be found in the scientific literature
for at least 15 years. Case reports of
infants presenting to the emer-
gency department with OTC cold
medication toxicity appear in Pedi-
atrics as early as 1992, with the
authors noting that in 1990, 1 in 15
calls to the Maryland Poison Cen-
ter were regarding cough and cold
medications (Gadomski & Horton,
1992). During 2004 and 2005, an
estimated 1519 children younger
than 2 years were treated in emer-
gency departments for either over-
dose or other adverse event asso-
ciated with cough and cold
medications (Centers for Disease
Control and Prevention [CDC],
2007).
In the past 5 years, multiple
studies pointing to OTC cold med-
ications as the cause of death in
infants have been published. The
Montgomery County Ohio Coro-
ner reported a series of 10 infant
deaths in 8 months with toxicology
findings confirming the presence
of ingredients found in OTC cold
medications (Marinetti et al., 2005).
The authors note toxicology re-
ports confirm that combination
cold products were administered
by parents or caregivers in nine of
the 10 infant deaths (Marinetti et
al.). The Philadelphia Medical Ex-
aminers Office reported on a series
of 15 deaths of infants and toddlers
between February 1999 and June
2005 in which pseudoephedrine
was present in the blood or tissues
of all the cases (Wingert, Mundy,
Collins, & Chmara, 2007). Pseudo-
ephedrine was confirmed to have
contributed to or caused the death
in eight of the 15 infants, with high
levels of pseudoephedrine present
in two other cases, with the pri-
mary cause of death listed as pneu-
monia in one case and undeter-
mined cause in the second
(Wingert et al.). A survey of 15
medical examiners from 12 states
by the National Association of
Medical Examiners identified three
infant deaths in 2005 associated
with cold medications, specifically
pseudoephedrine that was found
in high levels on postmortem tox-
icology reports of all three infants
(CDC, 2007).
A consistent finding in the re-
ports of infant deaths is the high
levels of medication found during
postmortem toxicology reports.
Several possible reasons for this
finding are suggested in the litera-
ture, including lack of dosing
guidelines for infants and toddlers,
product labeling that is confusing
to parents, multiple active ingredi-
ents in products that lead to acci-
dental overdosing, and multiple
caregivers administering medica-
tion to children, leading to acci-
dental overdose.
Lack of FDA Dosing
Guidelines for Children
Younger Than 2 Years
There are no Food and Drug Ad-
ministration (FDA) approved dosing
recommendations for the use of
cough and cold medications in chil-
dren younger than 2 years (CDC,
2007). Safety and efficacy studies
have not been conducted in this age
group; therefore, the dosages in
which cough and cold medications
cause illness and death in children
younger than 2 years is not known.
In a recent CDC study of three infant
deaths, pseudoephedrine levels
were nine to 14 times what should
have been found with recom-
mended dosing based on children
age 2 to 12 years (CDC). Cough and
cold product labeling clearly states
that parents should consult their pe-
diatric provider prior to administer-
ing the medication to young infants,
yet when a product is labeled for
“infants,” parents may disregard the
product labeling. Box 1 lists prod-
ucts that have been voluntarily with-
drawn from the market with confus-
ing labeling messages.
The wide variety of product
forms available confuse parents,
with drops, elixirs, chewable tab-
March/April 2008 75
 BOX 1. Infant cough and cold medications voluntarily withdrawn from the market

● Dimetapp Decongestant Plus Cough Infant Drops

● Dimetapp Decongestant Infant Drops
● Little Colds Decongestant Plus Cough
● Little Colds Multi-Symptom Cold Formula
● Pediacare Infant Drops Decongestant (containing pseudoephedrine)
● Pediacare Infant Drops Decongestant & Cough (containing pseudoephedrine)
● Pediacare Infant Dropper Decongestant (containing phenylephrine)
● Pediacare Infant Dropper Long-Acting Cough
● Pediacare Infant Dropper Decongestant & Cough (containing phenylephrine)
● Robitussin Infant Cough DM Drops
● Triaminic Infant & Toddler Thin Strips Decongestant
● Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough
● Tylenol Concentrated Infants’ Drops Plus Cold
● Tylenol Concentrated Infants’ Drops Plus Cold & Cough
Data from Consumer Healthcare Products Association, 2007.

lets, and medicated strips avail-
able. Adding to the misunder-
standing is the graphic on labels,
which may depict a toddler-aged
child, even though the labeling
states not to give the product to
children younger than 2 years.
Medication-impregnated strips that
dissolve when placed on the
tongue are marketed to parents to
make medication administration
easier. The concern for these prod-
ucts is that they are dosed for chil-
dren age 6 to 12 years, yet devel-
opmentally, it is usually children
younger than 6 years who refuse to
take medication. Night Time Tri-
aminic Thin Strips Cough and Cold
packaging depicts a child who ap-
pears to be significantly younger
than age 6 years, yet the product
dosing information fine print states
parents should consult their pro-
vider for dosing in children
younger than 6 years (Novartis
Consumer Health, 2007). Similar
graphics and dosing information is
found on Triaminic Softchews
Cough and Runny Nose (Novartis
Consumer Health). Sudafed PE
Quick Dissolve Strips are labeled
for use in children 12 years or
older and adults (McNeil-PPC,
2007). The Sudafed PE strips label
depicts an ageless head with si-
nuses highlighted, which is less
misleading for parents, yet the
product can easily be inappropri-
ately used in children by parents
seeking an easier method of ad-
ministering decongestants.
Multiple Ingredient Products
Parents may be confused by
product labeling and not understand
that many cough and cold products
contain multiple ingredients. They
may give a “cough” formula and a
“runny nose” formula based on the
symptoms their child is experienc-
ing, not understanding that they
may be doubling the dose of the
active ingredients. This is a concern
not only for cough and cold medi-
cations but also for antipyretics, be-
cause many products labeled
“cough and cold” also contain either
acetaminophen or ibuprofen. Acet-
aminophen above therapeutic levels
was documented in one infant death
reported by the Philadelphia Medi-
cal Examiners Office (Wingert et al.,
2007). As noted previously, combi-
nation cold products were adminis-
tered by parents or caregivers in
nine of the 10 infant deaths in the
Parents may be confused by product labeling
and not understand that many cough and cold
products contain multiple ingredients.
Montgomery County study (Mari-
netti et al., 2005).
Multiple Caregivers
Administering Medication
A problem unique to young
pediatric patients is that their
medication is administered by a
caregiver. Working parents and
multiple caregivers increase the
risk of accidental overdose if
caregivers do not communicate
with each other when medica-
tions are administered.
RECOMMENDATIONS FOR
USE OF COUGH AND COLD
MEDICATIONS
Pediatric nurse practitioners
(PNPs) need to be familiar with the
safety and efficacy of cold medica-
tions in children, including appro-
priate dosing for different aged chil-
dren. Parents need to be educated
regarding the appropriate use of
cough and cold medications in chil-
dren. Establishing a culture of safety
around the use of OTC cough and

76 Volume 22 • Number 2 Journal of Pediatric Health Care

 TABLE 1. Dosing of common cough and cold medications
Drug Age of child Dosing Maximum/24 h

Oral decongestants
Pseudoephedrine ⬍2 y Not recommended
2-5 y 15 mg q 6 hⴱ 60mg/24h
6-12 y 30 mg q 6 h 120mg/24h
⬎12 y 60 mg q 6 h 240mg/24h
Phenylephrine (Sudafed PE) ⬍2 y Not recommended
2-5 y 5 mg q 4 hⴱ
6-12 y 10 mg q 4 h
⬎12 y 10-20 mg q 4 h
Topical decongestants
Phenylephrine (Neo-Synephrine) 6-12 y 2-3 drops each nostril or 1-2 sprays of 0.25%
solution q 4 h
⬎12 y 2-3 drops each nostril or 1-2 sprays of 0.25%
or 0.5% solution q 4 h
Oxymetazoline (Afrin) ⬎6 y 2 sprays each nostril q 12 h
Cough suppressants
Dextromethorphan ⬍2 y Not recommended
⬎2-6 y 2.5 to 7.5 mg q 4 to 8 hrs* 30mg/24h
7-12 y 5-10 mg q 4 h or 15 mg q 6 to 8 h 60mg/24h
⬎12 y 10-30 mg q 4 to 8 h 120mg/24h
Expectorants
Guaifenesin ⬍2 y Not recommended
2-5 y 50-100 mg q 4 h 600mg/24h
6-11 y 100-200 mg q 4 h 1.2gm/24h
⬎12 y 200-400 mg q 4 h 2.4gm/24
q, Every.
*Cough and cold medications should be used with caution in children younger than age 6 years.

cold medications will encourage ap-
propriate use and decrease the like-
lihood of accidental overdose.
Prescribing Cough and Cold
Medications
Evidence is lacking regarding
the effectiveness of cough and
cold medications in children;
therefore, PNPs need to rethink
their prescribing practice if they
currently recommend these prod-
ucts. Understanding the rationale
for following FDA labeling recom-
mendations is crucial for patient
safety. An understanding of the
risks and benefits of prescribing
these medications and providing
parents with the correct dose for
their child will improve safety
when cough and cold medications
are prescribed.
Off-label prescribing. Off-la-
bel prescribing is the practice of
prescribing medications outside of
the FDA-approved label recom-
mendations. To pass through the
FDA labeling process, drug manu-
facturers need to provide pharma-
cokinetic, safety, and efficacy data
for all populations they want the
product label to reflect. Histori-
cally, a large number of pediatric
medications have been prescribed
off-label in children because stud-
ies were never done in this popu-
lation. Adult data were extrapo-
lated to determine pediatric dosing
with little attention to the develop-
mental pharmacokinetic differ-
ences in children. The FDA Mod-
ernization Act of 1997 and the Best
Pharmaceuticals for Children Act
of 2003 encourages pharmaceuti-
cal companies to perform pediatric
studies on medications, awarding
a 6-month extension on the patent
if pediatric studies are done. These
acts allowed the FDA to issue a
request to pharmaceutical compa-
nies for medications that may be
used in children. As a result, 138
medications have had pediatric
pharmacokinetic, safety, and effi-
cacy data updated and have been
relabeled. The first medication to
have labeling changes to add pre-
scribing information for 2- to
6-year-olds was ibuprofen suspen-
sion (Advil, Motrin) in 1998. The
only cough or cold products that
have gone through this relabeling
process as of November 2007 are
Advil Cold and Motrin Cold suspen-
sions (ibuprofen/pseudoephedrine).
Off-label prescribing is not il-
legal because the FDA only ap-
proves drugs to enter the market
and relabels when drug manufac-
tures submit additional data.
When choosing to prescribe out-
side the FDA approved label,
providers need to reflect on
whether there is strong evidence
in the literature supporting off-
label use of medications. Using
current prescribing references
such as The Harriet Lane Hand-
book, Micromedex, or Lexicomp’s
Pediatric Dosage Handbook will
determine the community stan-
dard of practice regarding off-la-
bel prescribing of specific medi-
cations, recognizing that even in
the Harriett Lane Handbook,

Journal of Pediatric Health Care March/April 2008 77

 BOX 2. Parent education regarding cough and cold medications

Pathophysiology of cough and upper respiratory infections

Symptomatic treatment for cough
● Warm fluids for coughing spasms
● Children aged 1 to 4 years: Corn syrup, ½ to 1 tsp for coughing spasms
● Children ⬎4 years: cough drops or hard candy to coat and sooth irritated throat and calm cough

Cough suppressants
● Generally not recommended for coughs in children
● If dry, hacky cough interferes with sleep, cough suppressants may be used in children ⬎2 years with clear guidelines for
use
● Cough suppressants are not to be used for wet, productive coughs
● Symptomatic treatment of congestion from upper respiratory infections
● Clear secretions from infant and toddler’s nose with a bulb syringe as needed
● Use saline drops to loosen dried nasal secretions for children of all ages at least four times a day and whenever children
cannot breathe through nose because of congestion
● Encourage fluid intake to keep secretions loose

Decongestants
● Systemic decongestants not recommended in children younger than 2 years
● Use with caution in children age 2 to 6 years
● Avoid multi-symptom products
● Provide parents with accurate dosing information
● Educate regarding use of topical decongestants
● Discourage use of sibling’s medications for younger children

Recording medication administered

● Encourage parents to make a written note of when medication was administered
● Parents and other caregivers need to communicate regarding what medications are administered and when to prevent
accidental overdose

more than 25% of the medica-
tions in the formulary lack FDA
labeling recommendations (No-
vak & Allen, 2007). In the case of
children’s cough and cold medi-
cations, the literature is clear re-
garding lack of evidence regard-
ing efficacy of these medications,
BOX 3. Adverse event
reporting
with clear recommendations
from the FDA and national orga-
nizations against use of cough
and cold medications in infants
and young children.
Appropriate dosing in pedi-
atric patients. With the myriad of
cough and cold formulas available,
if a provider chooses to prescribe
them for children, it is critical to
accurately dose the medication,
whether writing a prescription or
educating parents about medica-
tions. I recommend that PNPs fol-
low the FDA and AAP recommen-
dations that cough and cold
medications not be prescribed to
children younger than 2 years.
There is some concern by pediatric
experts regarding the safety of
these medications in children
younger than 6 years, and while

Report adverse events that may be

related to the use of cough or cold
medicines in children younger than It is clear from the literature that the use of
2 years to the FDA Med Watch
program. cough and cold medications in infants and
Online: young children is not recommended. Evidence
http://www.fda.gov/medwatch
is lacking for effectiveness in the treatment of
Phone:
1-800-FDA-1088
cough and congestion due to the common cold,
Mail: with real concerns for the safety of using these
FDA Med Watch 5600 Fishers medications in children younger than 2 years.
Lane, Rockville, MD 20852-9787

78 Volume 22 • Number 2 Journal of Pediatric Health Care

official statements have not been
issued, caution should be taken
when prescribing for children ages
2 to 6 years. Table 1 provides dos-
ing information for commonly
used cough and cold products. If
making recommendations to par-
ents, a dose in milligrams (mg)
with clear instructions regarding
dosing interval will decrease the
likelihood of accidental overdose.
The differences between formula-
tions such as infant drops, elixirs
or suspensions, chewable tablets,
and quick dissolve strips should be
discussed, and it should be recom-
mended that parents look at the
strength of each medication before
administering it. To encourage safe
use of medications, it is important to
encourage parents to contact the
provider (or advise nurse) before
administering any new OTC med-
ication to their child.
Educating Parents
Parent education should begin
with the underlying pathophysiology
of cough and colds. Education regard-
ing the natural progression of a viral
upper respiratory illness (URI) and the
expected duration of illness is essen-
tial. Parents often do not understand
that cough and cold medications are
for symptom relief, mistakenly think-
ing the medication is going to shorten
the duration of or cure the cold. A trip
to the drugstore with many feet of
shelf space dedicated to cough and
cold medicine may imply that these
medications are the expected treat-
ment for a URI. Educating parents re-
garding nonpharmacologic symptom-
atic care for colds, such as removing
secretions with a bulb syringe in in-
fants and toddlers, the use of saline
nose drops, and the use of a humidi-
fier will give them tools to use when
their child is uncomfortable because
of URI symptoms. Offering a “home-
made” cough syrup of corn syrup to
children older than 12 months gives
parents an alternative to OTC cough
medication when their child is cough-
ing (use of corn syrup in children
Journal of Pediatric Health Care
younger than 12 months is discour-
aged because of botulism concerns).
Encouraging parents to contact the
provider before administering any
OTC products to their child will de-
crease the likelihood of inappropriate
use. Box 2 discusses key parent edu-
cation that should occur regarding
cough and cold medication use in
children.
SUMMARY
It is clear from the literature that
the use of cough and cold medica-
tions in infants and young children
is not recommended. Evidence is
lacking for effectiveness in the
treatment of cough and congestion
due to the common cold, with real
concerns for the safety of using
these medications in children
younger than 2 years. PNPs should
review their practice regarding rec-
ommending OTC cough and cold
medications to determine if their
practice aligns with the standard of
practice set by the AAP. PNPs
should report suspected overdose
or adverse events from cough and
cold medications to the FDA Med
Watch program (Box 3). Proac-
tively educating parents regarding
the safety and efficacy of these
products in infants and young chil-
dren will counter pharmaceutical
advertising to parents. Offering
nonpharmacologic symptom con-
trol techniques will encourage par-
ents to hold off on reaching for
cough and cold medications, yet
still provide them with “something
to do” for URI symptoms. These
steps will ensure that OTC cough
and cold medications are used ap-
propriately in pediatric patients.
REFERENCES
American Academy of Pediatrics Committee on
Drugs. (1997). Use of codeine- and dextro-
methorphan-containing cough remedies in
children. Pediatrics, 99, 918-920.
Aronoff, D. M., & Neilson, E. G. (2001). Antipy-
retics: Mechanisms of action and clinical
use in fever suppression. The American
Journal of Medicine, 111, 304-315.
Bolser, D. C. (2006). Cough suppressant and
pharmacologic protussive therapy:
ACCP evidence-based clinical practice
guidelines. Chest, 129(Suppl. 1),
238S-249S.
Centers for Disease Control and Prevention
(2007). Infant deaths associated with
cough and cold medications—two
states, 2005. MMWR: Morbidity & Mor-
tality Weekly Report, 56, 1-4.
Gadomski, A., & Horton, L. (1992). The
need for rational therapeutics in the use
of cough and cold medicine in infants.
Pediatrics, 89, 774-776.
Harris, G. (2007, October 20). F.D.A panel
urges ban on medicines for child colds.
Retrieved January 16, 2008, from
http://www.nytimes.com/2007/10/20/
washington/20fda.html?_r⫽1&scp⫽
4 & sq ⫽ cold ⫹ medications ⫹ and ⫹
children&oref⫽slogin.
Marinetti, L., Lehman, L., Casto, B., Harsh-
barger, K., Kubiczek, P., & Davis, J. (2005).
Over-the-counter cold medications-post-
mortem findings in infants and the relation-
ship to cause of death. Journal Of Analytical
Toxicology, 29, 738-743.
McLeod, R. L., Mingo, G., O’Reilly, S.,
Ruck, L. A., Bolser, D. C., & Hey, J. A.
(1998). Antitussive action of antihista-
mines is independent of sedative and
ventilation activity in the guinea pig.
Pharmacology, 57, 57-64.
McNeil-PPC. (2007). Sudafed PE Quick Dis-
solve Strips. Retrieved November 25,
2007, from http://www.sudafed.com/
products/pe_quickstrips.html
Naclerio, R. M., Proud, D., Kagey-Sobotka,
A. Lichtenstein, L. M., Hendley, J. O.,
Gwaltney, J. M., et al. (1988) Is hista-
mine responsible for the symptoms of
rhinovirus colds? A look at inflammatory
mediators following infection. Pediatric
Infectious Disease Journal, 7, 215-242.
Novak, E., & Allen, P. J. (2007). Prescribing
medications in pediatrics: Concerns re-
garding FDA approval and pharmacoki-
netics. Pediatric Nursing, 33, 64-70.
Novartis Consumer Health. (2007). Tri-
aminic: The medicine of motherhood.
Retrieved November 26, 2007, from
http://www.triaminic.com/us_en/
product_all.shtml
Schroeder, K., & Fahey, T. (2004). Over-the-
counter medications for acute cough in
children and adults in ambulatory set-
tings. Cochrane Database Of System-
atic Reviews (Online), 4, 1-21.
Taverner, D., & Latte, J. (2007). Nasal de-
congestants for the common cold. Co-
chrane Database Of Systematic Re-
views (Online)(1), CD001953.
Wingert, W. E., Mundy, L. A., Collins, G. L.,
& Chmara, E. S. (2007). Possible role of
pseudoephedrine and other over-the-
counter cold medications in the deaths
of very young children. Journal of Fo-
rensic Sciences, 52, 487-490.
March/April 2008 79