Robitussin Pediatric Dosing (Guaifenesin)
For pediatric patients, guaifenesin dosing is age-based: children 6 to under 12 years should receive 5-10 mL (100-200 mg) every 4 hours, children 2 to under 6 years should receive 2.5-5 mL (50-100 mg) every 4 hours, and children under 2 years require physician consultation before use, with a maximum of 6 doses in 24 hours. 1
Age-Specific Dosing Guidelines
The FDA-approved dosing for guaifenesin follows a structured age-based approach 1:
- Ages 12 years and older: 10-20 mL (200-400 mg) every 4 hours 1
- Ages 6 to under 12 years: 5-10 mL (100-200 mg) every 4 hours 1
- Ages 2 to under 6 years: 2.5-5 mL (50-100 mg) every 4 hours 1
- Under 2 years: Physician consultation required before administration 1
Do not exceed 6 doses in any 24-hour period regardless of age. 1
Clinical Considerations and Safety Profile
Evidence for Efficacy
The clinical evidence for guaifenesin in pediatric populations is limited. While guaifenesin is marketed as an expectorant to loosen mucus and make coughs more productive, objective studies have not consistently demonstrated antitussive effects 2. However, subjective patient reports suggest potential benefits in reducing sputum thickness (96% vs 54% with placebo, p=0.01) and quantity 2.
Safety and Adverse Events
Guaifenesin has a well-established favorable safety profile in pediatric populations. 3 A large surveillance study of cough and cold medications found an overall adverse event rate of only 0.573 cases per 1 million units sold 4. Importantly:
- No fatalities involved therapeutic doses of any cough/cold medication ingredient including guaifenesin 4
- Most adverse events (67.1%) resulted from accidental unsupervised ingestions, not therapeutic use 4
- Single-ingredient, pediatric liquid formulations were most commonly involved in reported cases 4
Critical Safety Warnings
The most important risk factor is accidental overdose from unsupervised access. 4 Store medications securely out of children's reach, as 67.1% of adverse events involved accidental ingestions 4.
Medication errors accounted for 13% of adverse events, emphasizing the need for careful dose measurement using appropriate measuring devices rather than household spoons 4.
When to Seek Medical Attention
For infants under 2 years or any child with concerning symptoms, physician evaluation is necessary before administering guaifenesin 1. Specific indications for medical attention include:
- Respiratory symptoms persisting beyond 48-72 hours without improvement 5
- Fever, especially in infants under 3 months 5
- Signs of respiratory distress including rapid breathing, retractions, or cyanosis 5
- Decreased feeding or activity level 5
Alternative Management Strategies
For infants under 2 years, non-pharmacologic interventions are preferred over cough medications. 5 These include: