ZYRTEC-D 12 HOUR
LOE Approachingcetirizine hydrochloride and pseudoephedrine hydrochloride
NDAORALTABLET, EXTENDED RELEASE
Approved
Aug 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
ZYRTEC-D 12 HOUR (cetirizine hydrochloride and pseudoephedrine hydrochloride) by Aurobindo Pharma. Approved for these symptoms due to hay fever, other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose and 2 more indications. First approved in 2001.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYRTEC-D 12 HOUR is a combination oral antihistamine and decongestant containing cetirizine hydrochloride and pseudoephedrine hydrochloride in extended-release tablet form. It treats upper respiratory allergy symptoms including hay fever, nasal congestion, sneezing, and itchy/watery eyes by blocking histamine receptors and reducing nasal passage swelling. The product provides 12-hour symptom relief and temporarily restores nasal breathing.
LOE Approaching
As a mature OTC product approaching loss of exclusivity, the brand team faces declining revenue and likely workforce reduction; focus shifts to cost optimization and generic transition management.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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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.