desloratadine and pseudoephedrine sulfate

FDA Drug Profile — CLARINEX-D 12 HOUR

Drug Details

Generic Name
desloratadine and pseudoephedrine sulfate
Brand Names
CLARINEX-D 12 HOUR
Application Number
NDA021313
Sponsor
Organon LLC
NDC Codes
1
Dosage Forms
TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
DESLORATADINE, PSEUDOEPHEDRINE SULFATE

Indications and Usage

1 INDICATIONS AND USAGE CLARINEX-D 12 HOUR is a combination product containing a histamine-1 (H1) receptor antagonist and an alpha adrenergic agonist indicated for: Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. ( 1.1 ) 1.1 Seasonal Allergic Rhinitis CLARINEX-D ® 12 HOUR Extended Release Tablets is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. CLARINEX-D 12 HOUR Extended Release Tablets should be administered when the antihistaminic properties of desloratadine and the nasal decongestant properties of pseudoephedrine are desired [see Clinical Pharmacology (12) ].