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 17h ago · AI intelligence enriched 20h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Advil Congestion Relief is an oral tablet combining ibuprofen (NSAID) and phenylephrine hydrochloride (decongestant) approved in 2010 to treat cold and flu symptoms including headache, fever, sinus pressure, nasal congestion, and minor body aches. The ibuprofen reduces inflammation and pain via cyclooxygenase inhibition, while phenylephrine temporarily shrinks nasal passage swelling to restore breathing.
LOE Approaching
Product approaching loss of exclusivity signals defensive positioning; commercial team focus likely shifting to line extensions, reformulations, or adjacent OTC products to maintain market presence.
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.