NDAORALCAPSULE
Approved
May 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
ADVIL COLD AND SINUS (ibuprofen, pseudoephedrine 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. First approved in 2002.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Advil Cold and Sinus is an oral capsule combining ibuprofen (a nonsteroidal anti-inflammatory) and pseudoephedrine hydrochloride (a decongestant) approved in 2002. It treats common cold and flu symptoms including headache, fever, sinus pressure, nasal congestion, and minor body aches. The ibuprofen component works by inhibiting cyclooxygenase enzymes to reduce inflammation and pain, while pseudoephedrine acts as a nasal decongestant.
LOE Approaching
As LOE approaches, the brand team will likely shift focus toward lifecycle extensions, cost optimization, and preparation for generic competition in the OTC cold/sinus relief category.
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.