Detail-Document #220107

−This Detail-Document accompanies the related article published in−

PHARMACIST’S LETTER / PRESCRIBER’S LETTER
January 2006 ~ Volume 22 ~ Number 220107

Pediatric Doses for Commonly Used OTCs

— See FDA advisory concerning use of cough/cold meds in children <2 years old (http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm) —
When administering medication to infants and children, there are a number of important considerations. These include:
• Children cannot be considered “little adults.” Ideally, medication doses should be calculated based on age and weight.
• Always use a calibrated medication syringe, dropper, or cup. A kitchen teaspoon can vary between 2 mL and 10 mL and could result in significant
underdosing or overdosing of a medication.1,2 Some products come with a dose measuring device. Use the dosing device provided for the product
being used. Do not mix and match dosing devices.
• Medications should not be mixed in a bottle of milk or formula, because if the entire bottle is not consumed, the child may not get the entire dose.2
• Counsel parents that many cough and cold preparations contain a number of ingredients. Review the ingredients to make sure children are not getting
the same medication (i.e., acetaminophen) in more than one preparation.
• Use caution when recommending brand names. For example. Kaopectate formerly contained attapulgite. But, recently, the formulation was changed,
and the current Kaopectate product contains bismuth subsalicylate, the same ingredient as Pepto-Bismol.
• Use caution with dosage forms. These sometimes have differing concentrations. Parents should be advised to check the product label and follow the
directions carefully.
• Parents should be reminded not to call medications “candy.” If children come upon medications at a later time, they may consider it “candy” and ingest
it without supervision.
—For Healthcare Professional Use— —Chart last modified July 2012—
Generic Name Recommended Dose** Maximum Daily Notes
(Brand Name) (mg/kg dose should not exceed adult dose) Dose
Analgesics
Acetaminophen3,6 • Infants and children (Doesn’t apply to neonates) 75 mg/kg/day Use caution with dosage forms.1,4
(Tylenol, Tempra, 10 to 15 mg/kg PO or 10 to 20 mg/kg PR (PO/PR)13 Some infant drops are more
Panadol, others) q4 to 6h prn (Proposed max adult concentrated (80 mg/0.8 mL or
daily dose=2600 mg.)22 80 mg/1 mL) compared with children’s
OR by age (Oral) suspension (160 mg/5 mL). Some
• 0-3 months – 40 mg q4 to 6h prn 5 doses in 24h manufacturers are also switching their
• 4-11 months – 80 mg q4 to 6h prn “infant” formulations to a 160 mg/5 mL
• 12-24 months – 120 mg q4 to 6h prn strength.23
• 2-3 years – 160 mg q4 to 6h prn
• 4-5 years – 240 mg q4 to 6h prn Higher (30 mg/kg) oral loading doses
• 6-8 years – 320 mg q4 to 6h prn have been safely used to improve
• 9-10 years – 400 mg q4 to 6h prn antipyretic efficacy.5
• 11-12 years – 480 mg q4 to 6h prn
More. . .
Copyright © 2006 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
 (Detail-Document #220107: Page 2 of 5)

Generic Name Recommended Dose** Maximum Daily Notes

(Brand Name) (mg/kg dose should not exceed adult dose) Dose
Ibuprofen3,6 • Infants and children 40 mg/kg/24h or Use caution with dosage forms. Infant
(Motrin, Advil, 5 to 10 mg/kg q6 to 8h prn 2400 mg/day drops are more concentrated
others) OR whichever is less (50 mg/1.25 mL in the U.S. and
• 6-11 months – 50 mg q6 to 8h prn 40 mg/1 mL in Canada) compared with
• 12-23 months – 75 mg q6 to 8h prn children’s suspension (100 mg/5 mL).3
• 2-3 years – 100 mg q6 to 8h prn 4 doses in 24 hours For fever in infants/children 6 months
• 4-5 years – 150 mg q6 to 8h prn to 12 years:
• 6-8 years –– 200 mg q6 to 8h prn Temperature < 102.5°F (39°C):
5mg/kg/dose q6 to 8h prn
• 9-10 years – 250 mg q6 to 8h prn
Temperature > 102.5°F (39°C):
• 11 years – 300 mg q6 to 8h prn
10mg/kg/dose q6 to 8h prn.6
Antihistamines – OTC cough/cold products should NOT be used in children < 2 years old per FDA*17
Brompheniramine3,12 • Infants and neonates – not recommended In small children, no evidence of benefit
(often in combination • 2-6 years – 0.5 mg/kg/24h divided 6 mg/24h for treating colds other than inducing
with decongestants) q6 to 8h prn or 1 mg q4 to 6h prn sleepiness.7-10
• 6-12 years – 2 to 4 mg/dose q6 to 8h prn 12 mg/24h
21
Cetirizine • Less than 2 years – dosing information not None.
(Zyrtec, others) available
• 2-5 years – 2.5 mg once daily. Can increase to 5 mg/24h
5 mg once daily or 2.5 mg q12h
• 6 years or older – 5 mg to 10 mg once daily 10 mg/24h
3
Chlorpheniramine • 0.35 mg/kg/24h divided q4 to 6h prn In small children, no evidence of benefit
(Chlor-Trimeton, OR for treating colds other than inducing
others) • Less than 2 years – dosing information not sleepiness.7-10
available
• 2-6 years – 1 mg/dose q4 to 6h prn 6 mg/24h
• 6-12 years – 2 mg/dose q4 to 6h prn or 12 mg/24h
8 mg (sustained release) q12h prn
DiMENhydrinate3 • Less than 2 years – not recommended Should only be used in the treatment of
(Dramamine, others) • 2 years or older - 5 mg/kg/24h divided q6h prn 2-6 years – 75 mg/24h prolonged vomiting with a known
6-12 years – cause.3 These doses can also be used for
150 mg/24h motion sickness.
More. . .
Copyright © 2006 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
 (Detail-Document #220107: Page 3 of 5)

Generic Name Recommended Dose** Maximum Daily Notes

(Brand Name) (mg/kg dose should not exceed adult dose) Dose
DiPHENhydramine • 5 mg/kg/24h divided q6h prn*,3 OR 300 mg/24h3 (per some Do not use in neonates due to potential
(Benadryl, others) • Not for children < 2 years18 clinicians, 200 mg/24h) for CNS effects.3 May cause excitation
• 2-5 years – 6.25 mg q4 to 6h prn19 4 doses/day19 in young children.16 In small children,
• 6-<12 years – 12.5 mg to 25 mg q4 to 6h prn18 6 doses/day18 no evidence of benefit for treating colds
• >12 years – 25 mg to 50 mg q4 to 6h prn18 6 doses/day18 other than inducing sleepiness.7-10
Loratadine3 • Less than 2 years – dosing information not None.
(Claritin, others) available
• 2-5 years – 5 mg once daily 5 mg/24h
• 6 years or older – 10 mg once daily 10 mg/24h
Expectorants and Cough Suppressants – OTC cough/cold products should NOT be used in children <2 years old per FDA*17
Dextromethorphan6 • Less than 2 years – dosing information not well The American Academy of Pediatrics
(Benylin, Delsym, established recommends against the use of
others) • 2-6 years – 2.5 to 7.5 mg q4 to 8h prn or 15 mg 30 mg/24h dextromethorphan in children due to the
q12h prn (sustained-release suspension) lack of proven effect.11
• 6-12 years – 5 to 10 mg q4h prn or 30 mg q12h 60 mg/24h
prn (sustained-release suspension)
Guaifenesin3,12 • 6 months-2 years–12 mg/kg/24h divided q4h prn* 300 mg/24h Clear evidence of beneficial effects in
(Robitussin, others) • 2-5 years – 50 to 100 mg q4h prn 600 mg/24h children is lacking. 7-10
• 6-11 years – 100 to 200 mg q4h prn 1200 mg/24h
Decongestants – OTC cough/cold products should NOT be used in children <2 years old per FDA*17
Phenylephrine3 • Infants less than 6 months – dosing information None specified. Do not Can be used for up to three days. If the
(Neo-Synephrine, not available use longer than 3 days. 0.16% or the 0.125% solution are not
Little Noses, others) • Infants older than 6 months – 1 to 2 drops of commercially available, may dilute
0.16% solution in each nostril q3h prn* 0.25% with normal saline to achieve
• Less than 6 years – 2 to 3 drops of 0.125% desired concentration. Overuse can lead
solution in each nostril q4h prn to chronic inflammatory rhinitis.7
• 6-12 years – 2 to 3 drops or 1 to 2 sprays of
0.25% solution in each nostril q4h prn
Phenylephrine • <2 yrs-dosing information not available Use of decongestants in children has been
HCl14,15 (Oral, various • 2-<6 years − 2.5 mg q4h prn 15 mg/24h associated with irritability, hallucinations,
OTC products) 30 mg/24h hypertension, and dystonic reactions.11 Rx
• 6-<12 years − 5 mg q4h prn
dosing may differ from OTC.

More. . .
Copyright © 2006 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
 (Detail-Document #220107: Page 4 of 5)

Generic Name Recommended Dose** Maximum Daily Notes

(Brand Name) (mg/kg dose should not exceed adult dose) Dose
Pseudoephedrine3 • Children less than 12 years – 4 mg/kg/24h divided Use caution in infants. The use of
(Sudafed, PediaCare q6h prn decongestants in children has been
Infant Decongestant OR associated with irritability,
Drops, others • Less than 2 years – 4 mg/kg/24h divided q6h prn* hallucinations, hypertension, and
• 2-5 years – 15 mg q6h prn 60 mg/24h dystonic reactions.11 Use caution with
• 6-12 years – 30 mg q6h prn 120 mg/24h dosage forms. Infant drops are more
concentrated compared with children’s
liquid.3
Antidiarrheals
Bismuth • 100 mg/kg/24h in 5 divided doses 4190 mg/24h for up to Not recommended for children less than
subsalicylate3 OR 5 days 16 years with flu-like symptoms or
(Pepto-Bismol, (doses given q30 minutes to 1h prn up to 8 doses/24h) chickenpox due to the risk of Reye’s
others) • Less than 3 years – dosing information not Syndrome. Use caution in patients with
available. renal dysfunction, gastritis, or bleeding
• 3-6 years – 87.3 mg 8 doses/24h disorders.3
• 6-9 years – 174.7 mg 8 doses/24h
• 9-12 years – 262 mg 8 doses/24h
Loperamide3 Initial day Avoid in children less than 2 years due
(Imodium, others) • Less than 2 years – dosing information not to reports of necrotizing enterocolitis.
available Do not use more than 2 mg/dose.
• 2-6 years – 1 mg q8h 3 mg/24h Discontinue in 48 hours if no
• 6-8 years – 2 mg q12h 4 mg/24h improvement. 3
• 8-12 years – 2 mg q8h 6 mg/24h
After initial day, 0.1 mg/kg/dose after each loose
bowel movement (not to exceed recommended doses
on initial day)
Laxatives – See our PL Chart, Treatment of Constipation in Children, for a list of laxatives and their pediatric doses.

*The FDA does not recommend the use of OTC cough/cold products in children < 2 years old.17 The American Academy of Pediatrics recommends
avoiding use of OTC cough/cold medicines in children <6 years old.20
**Some of these doses are not approved by the Food and Drug Administration. Use clinical judgment before using this information.
All doses are the oral dose unless otherwise specified. All doses assume normal renal and hepatic function.
Abbreviations: PO – by mouth, PR – rectally, prn – as needed, h – hours, q – every.
More. . .
Copyright © 2006 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
 (Detail-Document #220107: Page 5 of 5)

Users of this document are cautioned to use their own 13. Personal communication. Carol Taketomo (Ed).
professional judgment and consult any other necessary Pediatric Lexi-Durgs. June 5, 2006.
or appropriate sources prior to making clinical 14. Scolaro KL. Disorders related to cold and allergy.
judgments based on the content of this document. Our In: Berardi RR, et al, Ed. Handbook of
th
Nonprescription Drugs. 15 ed. Washington, DC:
editors have researched the information with input from American Pharmacists Association, 2006.
experts, government agencies, and national 15. FDA. Cold, cough, allergy, bronchodilator, and
organizations. Information and Internet links in this antiasthmatic drug products for over-the-counter
article were current as of the date of publication. human use (final monograph, 21CFR341). April 1,
2001. http://www.accessdata.fda.gov/scripts/cdrh
Project Leader in preparation of this Detail- /cfdocs/cfCFR/CFRSearch.cfm?CFRPart=341.
(Accessed November 3, 2006).
Document: Neeta O’Mara, Pharm.D., BCPS 16. Taketomo C, Ed. Childrens Hospital Los Angeles:
th
Pediatric Dosing Handbook & Formulary. 18 ed.
References Los Angeles, CA:Lexi-Comp, Inc., 2006-2008.
1. Madlon-Kay DJ, Mosch FS. Liquid medication dosing 17. FDA. FDA recommends that over-the-counter (OTC)
errors. J Fam Pract 2000;49:741-4. cough and cold products not be used for infants and
2. Pagliaro AM. Administering drugs to infants, children children under 2 years of age. January 17, 2008
and adolescents. In: Pagliaro LA, Pagliaro AM, (eds). (update October 2008).
Problems in Pediatric Drug Therapy. 4th ed. http://www.fda.gov/Drugs/DrugSafety/PostmarketDru
American Pharmaceutical Association, Washington, gSafetyInformationforPatientsandProviders/DrugSafe
DC, 2002. tyInformationforHeathcareProfessionals/PublicHealth
3. The Harriet Lane Handbook. 17th ed. Gunn VL, Advisories/ucm051137.htm. (Accessed February 4,
Nechyba C, eds. Mosby Inc. Philadelphia, PA. 2005. 2008).
4. American Academy of Pediatrics. Acetaminophen 18. Product information for Children’s Benadryl.
toxicity in children. Pediatrics 2001;108:1020-24. www.benadryl.com. (Accessed July 15, 2008).
5. Treluyer JM, Tonnelier S, d'Athis P, et al. Antipyretic 19. Compendium of Pharmaceuticals and Specialties,
efficacy of an initial 30 mg/kg loading dose of online version (e-CPS). Canadian Pharmacists
acetaminophen versus a 15-mg/kg maintenance Association, 2008. http://www.e-therapeutics.ca.
dose. Pediatrics 2001;108:E73. (Accessed July 15, 2008).
6. Pediatric Lexi-Drugs Online 2006. Lexi-Comp, Inc. 20. American Academy of Pediatrics. Withdrawal of cold
Hudson, OH. http://www.lexi.com. (Accessed medicines: addressing parent concerns (2008).
January 9, 2006). http://practice.aap.org/content.aspx?aid=2254.
7. Kelly LF. Pediatric cough and cold preparations. (Accessed October 8, 2008).
Pediatr Rev 2004;25:115-23. 21. Product information for Zyrtec. McNeil Consumer
8. Schroder K, Fahey T. Over-the-counter medications Healthcare. http://www.zyrtec.com. (Accessed July
for acute cough in children and adults in ambulatory 10, 2010).
settings. (Cochrane review). In: The Cochrane 22. FDA. Acetaminophen overdose and liver injury-
Library, Issue 2, 2004. Oxford: Update. background and options for reducing injury. May
9. DeSutter AIM, Lemiengre M, Campbell H, Mackinnon 2009.
HF. Antihistamines for the common cold (Cochrane http://www.fda.gov/downloads/AdvisoryCommittees/
review). In: The Cochrane Library, Issue 3, 2003. CommitteesMeetingMaterials/Drugs/DrugSafetyandR
Oxford: Update. iskManagementAdvisoryCommittee/UCM164897.pdf.
10. Arroll B. Non-antibiotic treatments for upper- (Accessed July 29, 2010).
respiratory tract infections (common cold). Respir 23. FDA. FDA drug safety communication: addition of
Med 2005;99:1477-84 another concentration of liquid acetaminophen
11. American Academy of Pediatrics. Use of codeine- marketed for infants. December 22, 2011. http:
and dextromethorphan-containing cough remedies in //www.fda.gov/drugs/drugsafety/ucm284741.htm.
children. Pediatrics 1997;99:918-20. (Accessed July 13, 2012).
12. Hochadel MA (ed). Clinical Pharmacology 2006.
Gold Standard Multimedia Inc., Tampa, FL.

Cite this Detail-Document as follows: Dosing of OTC products in the pediatric population. Pharmacist’s
Letter/Prescriber’s Letter 2006;22(1):220107.

Evidence and Advice You Can Trust…

3120 West March Lane, P.O. Box 8190, Stockton, CA 95208 ~ TEL (209) 472-2240 ~ FAX (209) 472-2249
Copyright © 2006 by Therapeutic Research Center

Subscribers to Pharmacist’s Letter and Prescriber’s Letter can get Detail-Documents, like this one, on any
topic covered in any issue by going to www.pharmacistsletter.com or www.prescribersletter.com