NDAORALTABLET, EXTENDED RELEASE
Approved
Jul 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
2/8 — Basic
Drug data last refreshed 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MUCINEX is an oral extended-release tablet containing guaifenesin, an expectorant that helps thin and loosen mucus to make coughs more productive. It is used to relieve chest congestion caused by the common cold, bronchitis, and other respiratory conditions. Guaifenesin works by reducing mucus viscosity, making it easier to expel through coughing.
LOE Approaching
Approaching loss of exclusivity with moderate competitive pressure (30%), suggesting a mature product team focused on defensive strategies rather than growth initiatives.
Mechanism of Action
Pharmacologic Class:
Expectorant
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg Under Fasting Conditions
Started Dec 2014
80 enrolled
Healthy
Comparison Between Oxomemazine, Guaifenesin and Potassium Iodate Versus Guaifenesin Monotherapy in Acute Cough Treatment
Started Oct 2012
260 enrolled
Cough
Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Syrup in Patients Suffering a Upper Respiratory Tract Infection (URTI)
Started Mar 2012
51 enrolled
Upper Respiratory Infections
Exploratory Efficacy Study of Guaifenesin in Upper Back Pain
Started Feb 2012
78 enrolled
Upper Back Pain
The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study
Started May 2011
30 enrolled
Chronic Rhinitis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.