NDAORALTABLET
Approved
Sep 1989
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
5/8 — Partial
ADVIL COLD AND SINUS (ibuprofen and pseudoephedrine hydrochloride) by GSK is cyclooxygenase inhibitors [moa]. Approved for these symptoms associated with the common cold, flu:. First approved in 1989.
Drug data last refreshed 1h ago · AI intelligence enriched 4h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Advil Cold and Sinus is an oral tablet combining ibuprofen (NSAID) and pseudoephedrine hydrochloride (decongestant) approved in 1989 for treating symptoms of the common cold and flu. It works via cyclooxygenase inhibition to reduce inflammation and pain while the decongestant relieves nasal congestion. This fixed-dose combination targets symptomatic relief in self-care/OTC settings.
LOE Approaching
Product is in late-stage maturity with LOE approaching; team focus likely shifting toward cost management, generic transition planning, and protecting remaining market share in OTC cold/flu category.
Mechanism of Action
Cyclooxygenase Inhibitors
Pharmacologic Class:
Nonsteroidal Anti-inflammatory Drug
Indications (2)
Clinical Trials (1)
Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets
Started Apr 2014
66 enrolled
Pain, HeadPain, AcutePain, Back+1 more
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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.