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 8h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Advil Cold and Sinus is a fixed-dose combination oral tablet containing ibuprofen (NSAID) and pseudoephedrine HCl (decongestant) approved in 1989. It treats symptoms associated with the common cold and flu by reducing inflammation and nasal congestion through cyclooxygenase inhibition and sympathomimetic action. The product targets consumers seeking multi-symptom relief in an over-the-counter setting.
LOE Approaching
As an OTC product approaching LOE with moderate competitive pressure (30/100), the brand team is likely focused on line extension and differentiation rather than growth expansion.
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.