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Mucinex (guaifenesin)
Guaifenesin (Mucinex) is the only FDA-approved OTC expectorant, available since the 1950s. Found in hundreds of cold/flu products. Available generically.
At a glance
| Generic name | guaifenesin |
|---|---|
| Also known as | Mucinex, Robitussin (component) |
| Sponsor | Generic (multiple manufacturers) |
| Drug class | Expectorant [EPC] |
| Target | Vagal gastric reflex → increased respiratory secretions |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1952-01-01 (United States) |
Approved indications
- Allergic rhinitis
- Common cold
- Cough
- Fever
- Headache disorder
- Influenza-like symptoms
- Nasal congestion
- Nasal discharge
- Rhinitis
- Sinus headache
Common side effects
Key clinical trials
- Efficacy of Two Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment (Phase 4)
- A Phase I, Open-label, Single-dose, Randomized, 2-way Cross-over Study Designed to Examine the Relative Bioavailability of Guaifenesin When a Mucinex Extended Release 600 mg Bi-layer Tablet is Taken U (Phase 1)
- A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough (FORTITUDE) (Phase 4)
- Ph-III Randomized, Multicentric, Controlled , Non-inferiority Trial to Evaluate the Safety and Efficacy of Mupirocin Gel 20 mg/g Versus Mupirocin Ointment 20 mg/g and Placebo in the Treatment of Impet (Phase 3)
- A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of a 12-week Add-on Treatment With LT-02 vs. Placebo in Subjects With Ulcerative Colitis Refractory to Standard Treatmen (Phase 3)
- The Effect on Thirst, Nausea-Vomiting, Hemodynamic Parameters, and Comfort Levels of Menthol Lozenge Applied After Extubation to Patients to Undergoing Cardiovascular Surgery (NA)
- Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule 300mg" as an Antitussive Agent in Acute Cough Patients. (Phase 3)
- Randomized , Placebo-controlled, Clinical Trial of Efficacy and Safety Evaluation of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improving the Signs and Symptoms of Infecti (Phase 3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |