When to give cough and cold medications to children?

When to Give Cough and Cold Medications to Children

Over-the-counter cough and cold medications should not be given to children under 4 years of age due to lack of proven efficacy and potential for serious adverse effects including death. 1, 2

Age-Based Recommendations

Children Under 4 Years

• Do not use OTC cough and cold medications 1, 2
• The FDA explicitly warns against using products containing antihistamines or decongestants in children younger than 2 years 3
• Major manufacturers voluntarily removed these products for children under 2 years from the market in 2007 4, 1
• FDA drug labels for dextromethorphan and diphenhydramine specifically state "do not use" for children under 4 years 5, 6

Children 4 to 6 Years

• Generally avoid OTC cold medications 1
• The FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended against use in children under 6 years 4, 1
• Between 1969-2006, there were 54 deaths from decongestants and 69 deaths from antihistamines in children under 6 years, with the majority occurring in infants under 1 year 4, 1

Children 6 Years and Older

• May use OTC cold medications according to package directions, though benefits remain limited 1
• Dextromethorphan dosing: 5 mL every 12 hours for ages 6-12 years, not exceeding 10 mL in 24 hours 5
• Diphenhydramine dosing: 10 mL (25 mg) every 4-6 hours for ages 6-12 years 6

Why These Medications Should Be Avoided in Young Children

Lack of Efficacy

• Controlled trials demonstrate that antihistamine-decongestant combinations are not effective for upper respiratory tract infection symptoms in young children 4, 1
• Systematic reviews conclude OTC cough medications have little to no benefit in symptomatic control of acute cough in children 1, 7
• Dextromethorphan is no different than placebo in reducing nocturnal cough or sleep disturbance 7

Safety Concerns

• Common causes of adverse events include using multiple products containing the same ingredients, leading to unintentional overdose 4, 1
• Studies show 8-11% of children receive excessive doses 2
• OTC drugs are among the most common unintentional ingestion medications in children under 5 years 1, 2
• The overall adverse event rate is 0.573 cases per 1 million units sold, with accidental unsupervised ingestions accounting for 67.1% of cases 8

Safe Alternatives for Cough Management

First-Line Treatment

• Honey (for children over 12 months): Provides more relief than no treatment, diphenhydramine, or placebo 4, 7, 2
• Never give honey to infants under 12 months due to botulism risk 7, 2

Supportive Care

• Adequate hydration and environmental humidification help thin secretions 2
• Nasal saline irrigation can reduce symptom severity 9
• Vapor rub may improve symptoms 9

Medications to Strictly Avoid

• Codeine-containing medications: Risk of serious side effects including respiratory distress 4, 7, 2
• In 2018, FDA restricted prescription opioid cough medicines to adults 18 years and older 1, 2

When to Consider Specific Treatments

For Chronic Cough (>2-4 weeks)

• Re-evaluate for emergence of specific etiological pointers 4, 7
• If asthma risk factors are present: Consider a 2-4 week trial of inhaled corticosteroids (400 mg/day beclomethasone equivalent) 4, 7
• Always re-evaluate after treatment trial, as resolution may be spontaneous 7

For Suspected Bacterial Infection

• High fever (≥38.5°C) persisting >3 days: Consider beta-lactam antibiotics 7
• Persistent nasal discharge or confirmed sinusitis: 10-day antimicrobial course (though number needed to treat is 8) 7
• Acute cough from common colds: Antimicrobials provide no benefit 7

Common Pitfalls to Avoid

• Do not prescribe OTC medications due to parental pressure despite lack of efficacy 7, 2
• Do not assume all cough represents asthma and treat with bronchodilators without evidence of airflow obstruction 1, 7
• Do not use topical decongestants for more than 3 days due to risk of rhinitis medicamentosa (rebound congestion) 4
• Do not fail to re-evaluate children whose cough persists despite treatment 7

Second-Generation Antihistamines: The Exception

For allergic rhinitis (not acute cough/cold), second-generation antihistamines are safe in children 6 years and older:

• Cetirizine, desloratadine, fexofenadine, levocetirizine, and loratadine have excellent safety profiles 4, 1
• These are well-tolerated with minimal cognitive and antimuscarinic side effects 1
• Intranasal corticosteroids are the most effective medication class for allergic rhinitis symptoms 4