Recommendations for the Use of OTC Cough and Cold Medications in Children

Ann McMahon Wicker, PharmD, BCPS; Brice A. Labruzzo, PharmD


US Pharmacist. 2009;34(3):33-36. 

In This Article


Antihistamines are reversible H1-receptor antagonists that block histamine activity in the respiratory tract, gastrointestinal (GI) tract, and blood vessels. They may help prevent and treat nasal and ocular itching, rhinorrhea, and sneezing associated with the common cold, but they have not been proven to prevent colds, cure them, or shorten the course. Side effects of antihistamines include drowsiness, nervousness, insomnia, dry mouth, and dizziness. OTC cold and allergy formulas for children contain first- or second-generation antihistamines. There is no FDA-approved dosing of antihistamines for colds; however, dosing for allergic rhinitis is given. The two classes differ mainly in their sedative effects, with first-generation antihistamines causing more sedation.[3,4,5,6]

First-generation antihistamines include chlorpheniramine, diphenhydramine, and brompheniramine. Appropriate dosing of chlorpheniramine in children aged 2 to 6 years is 0.35 mg/kg/day divided every four to six hours, with a maximum daily dose (MDD) of 6 mg. Recommended diphenhydramine dosing in children aged 2 to 6 years is 5 mg/kg/day divided six hours as needed, with an MDD of 300 mg. Diphenhydramine should not be used in neonates owing to possible central nervous system effects. Dosing of brompheniramine in patients aged 2 to 6 years is 1 mg every four to six hours.[2] Brompheniramine is not available OTC as a single-active-ingredient product, but it is found in combination with other active ingredients in pediatric cough and cold medications.

Second-generation antihistamines available OTC include cetirizine and loratadine. Appropriate cetirizine dosing in children is as follows: age 6 to 12 months, 2.5 mg/day; age 12 to 23 months, initial dosing 2.5 mg/day (may be increased to 2.5 mg twice/day); age 2 to 5 years, initial dosing 2.5 mg/day (may be increased to 5 mg/day in single or divided doses). The usual dose of loratadine for children aged 2 to 5 years is 5 mg once/day.[2]

Antihistamines should not be used to sedate children, and manufacturers of certain antihistamine products are making voluntary labeling changes that warn parents not to use the product with the intention of making a child sleepy.[1] Parents should avoid using antihistamines in children with glaucoma, breathing disorders, liver disease, or seizure disorders unless directed otherwise by their primary health care provider.[3,4,5,6]