Finished product reference
Azelastine Hydrochloride
Spray, Metered · Nasal · 137 µg/1 puff · 20 mL
- List code
- 52819
Indications
Azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. Azelastine hydrochloride nasal spray is an H1-receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.
Dosage and administration (summary)
For intranasal use only Seasonal allergic rhinitis: Pediatric patients 5 to 11 years of age: 1 spray per nostril twice daily Adults and adolescents 12 years of age and older: 1 or 2 sprays per nostril twice daily Vasomotor rhinitis: 2 sprays per nostril twice daily in adults and adolescents 12 years of age and older Prime azelastine hydrochloride nasal spray before initial use and when it has not been used for 3 or more days Seasonal Allergic Rhinitis The recommended dosage of azelastine hydrochloride nasal spray in adults and adolescent patients 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily.
Contraindications
None. None
Warnings and precautions
Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking azelastine hydrochloride nasal spray. Alcohol and other central nervous system (CNS) depressants: Avoid concurrent use with azelastine hydrochloride nasal spray because further decreased alertness and impairment of CNS performance may occur. Somnolence in Activities Requiring Mental Alertness In clinical trials, the occurrence of somnolence has been reported in some patients taking azelastine hydrochloride nasal spray .
Storage and supply
Product: 50090-2330 NDC: 50090-2330-0 200 SPRAY, METERED in a BOTTLE, SPRAY / 1 in a CARTON
Source: Azelastine Hydrochloride (Azelastine Hydrochloride) — US FDA prescribing information, 2025-11-06, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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