NDAORALTABLET
Approved
Dec 2002
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Data completeness
5/8 — Partial
ADVIL ALLERGY SINUS (chlorpheniramine maleate, ibuprofen, pseudoephedrine hcl) by GSK is cyclooxygenase inhibitors [moa]. Approved for these symptoms associated with hay fever, other upper respiratory allergies, the common cold: runny nose itchy and 3 more indications. First approved in 2002.
Drug data last refreshed 3h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ADVIL ALLERGY SINUS is a fixed-dose combination oral tablet containing ibuprofen (NSAID), chlorpheniramine maleate (antihistamine), and pseudoephedrine HCL (decongestant). It treats symptomatic relief of hay fever, upper respiratory allergies, and cold symptoms including congestion, sneezing, headache, and minor aches. The ibuprofen component works via cyclooxygenase inhibition to reduce inflammation and pain, while the other agents address allergic and congestion symptoms.
LOE Approaching8mo to LOE
As an OTC product approaching loss of exclusivity in early 2027, the brand team is likely focused on defending market share against generic competition and line extensions rather than growth initiatives.
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.