NDAORALTABLET
Approved
May 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
ADVIL CONGESTION RELIEF (ibuprofen, phenylephrine hydrochloride) by GSK is cyclooxygenase inhibitors [moa]. Approved for these symptoms associated with the common cold, flu: headache fever sinus pressure nasal congestion minor body aches, pains reduces swelling of the nasal passages temporarily restores freer breathing through the nose. First approved in 2010.
Drug data last refreshed 43m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Advil Congestion Relief is an oral tablet combining ibuprofen (a cyclooxygenase inhibitor) and phenylephrine hydrochloride (a decongestant) for symptomatic relief of cold and flu symptoms. It targets headache, fever, sinus pressure, nasal congestion, and minor body aches by reducing inflammation and temporarily restoring nasal airflow. This is a combination OTC product designed for short-term symptomatic management in otherwise healthy adults.
LOE Approaching
As an OTC product approaching loss of exclusivity with moderate competitive pressure (30/100), the brand team likely focuses on line extensions and consumer marketing rather than sales force expansion.
Mechanism of Action
Cyclooxygenase Inhibitors
Pharmacologic Class:
Nonsteroidal Anti-inflammatory Drug
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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.