OTC Drug for Productive Cough
For productive cough with phlegm, guaifenesin is the recommended over-the-counter expectorant, though evidence for its effectiveness is limited and conflicting. 1, 2
Adult Dosing
- Guaifenesin: 10-20 mL (200-400 mg) every 4 hours, maximum 6 doses per 24 hours 3
- The dosing range allows flexible titration to increase plasma concentrations as needed 2
- Multiple daily doses are required to maintain 24-hour therapeutic effect with immediate-release formulations 2
- Extended-release formulations are available for 12-hourly dosing convenience 2
Pediatric Dosing
- Children 6 to under 12 years: 5-10 mL (100-200 mg) every 4 hours 3
- Children 2 to under 6 years: 2.5-5 mL (50-100 mg) every 4 hours 3
- Children under 2 years: Consult a physician 3
- Maximum 6 doses in 24 hours for all pediatric age groups 3
Evidence Quality and Clinical Considerations
Limited Efficacy Data
- The ACCP guidelines state that mucokinetic agents (including expectorants) show no consistent favorable effect on cough in acute bronchitis and are not recommended (Grade I recommendation) 1
- In adults with acute cough, one larger study found 75% of guaifenesin users reported the medicine was helpful versus 31% in placebo (p<0.01), but a second study showed no statistically significant differences 4
- Guaifenesin has demonstrated clinical utility primarily in chronic respiratory conditions where mucus hypersecretion is more stable, rather than acute infections 2
Mechanism of Action
- Guaifenesin acts by loosening mucus in the airways and making coughs more productive 2
- It remains the only legally marketed expectorant in the US per OTC Monograph 2
Safety Profile
- Guaifenesin has a well-established and favorable safety profile in both adult and pediatric populations 2
- It is considered safe and effective for mucus-related symptoms in stable chronic bronchitis and acute upper respiratory tract infections 2
Important Clinical Pitfalls
- Green or yellow sputum suggests bacterial infection requiring medical evaluation 5
- Persistent cough beyond 3 weeks requires full diagnostic workup rather than continued symptomatic treatment 6
- For children, over-the-counter cough medicines lack strong efficacy evidence and can delay diagnosis of more serious underlying conditions 7
- Ensure patients are not taking multiple products simultaneously to avoid unintentional overdosing on combination ingredients 5