Guaifenesin Should Not Be Given to an 11-Month-Old Child
Do not administer 2.5 ml of guaifenesin to an 11-month-old infant, as the FDA-approved labeling explicitly states that guaifenesin is not recommended for children under 2 years of age without consulting a physician. 1
FDA Labeling Guidance
- The FDA drug label for guaifenesin clearly indicates that for "children under 2 years of age" the directive is to "consult a physician" rather than providing a specific dose. 1
- This age restriction exists because safety and efficacy data in infants under 2 years are insufficient to support routine over-the-counter use. 1
Age-Appropriate Dosing Parameters
- For children aged 2 to under 6 years, the FDA-approved dose is 2.5 to 5 mL (½ to 1 teaspoonful) every 4 hours, not to exceed 6 doses in 24 hours. 1
- An 11-month-old falls below this minimum age threshold and therefore does not have an established safe dosing regimen for over-the-counter use. 1
Pharmacokinetic Considerations in Young Children
- Pediatric pharmacokinetic studies of guaifenesin have been conducted in children aged 2 to 17 years, with age-based doses ranging from 100-400 mg, but these studies specifically excluded infants under 2 years. 2
- Oral clearance and volume of distribution increase with age due to body size maturation, suggesting that dosing extrapolated from older children may not be appropriate for infants. 2
- Allometric scaling studies indicate maturation-related changes in drug handling that make infant dosing particularly challenging without specific safety data. 2
Safety Profile and Risks
- While guaifenesin generally has a favorable safety profile in approved age groups, there is a documented case of fatal overdose in an adult, demonstrating that the drug can cause central nervous system depression and cardiac complications at toxic levels. 3
- The lack of established dosing for infants under 2 years reflects insufficient data on both efficacy and safety in this vulnerable population. 1
Clinical Recommendation
If your 11-month-old has symptoms requiring treatment (such as chest congestion), consult a pediatrician for appropriate evaluation and management rather than administering over-the-counter guaifenesin. 1 The physician can assess whether treatment is necessary and, if so, can prescribe appropriate therapy with proper dosing guidance specific to your infant's age, weight, and clinical condition. 1