{"active_ingredient":["Active ingredient(s) Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)"],"ask_doctor":["Ask a doctor before use if you have had recent nose ulcers or nose surgery have had nose injury that has not healed"],"do_not_use":["Do not use if you have if you have ever had an allergic reaction to this product or any of its ingredients"],"dosage_and_administration":["Directions Read the User Guide for how to: prime the bottle before first use use the spray prime bottle again if not used for 3 or more days clean the spray nozzle if it gets clogged adults and children 12 years and older This product may be used either once or twice a day: once daily: use 2 sprays in each nostril;OR twice daily: use 1 or 2 sprays in each nostril every 12 hours do not use more than 4 spraysin each nostril in a 24 hour period children 6 years to 11 years an adult should supervise use 1 spray in each nostril every 12 hours do not use more than 2 spraysin each nostril in a 24 hour period children under 6 years do not use"],"dosage_and_administration_table":["<table frame=\"border\" rules=\"all\"><col/><col/><tbody><tr><td>adults and children 12 years and older</td><td>This product may be used either once or twice a day: <list listType=\"unordered\" styleCode=\"Disc\"><item>once daily: use 2 sprays in each nostril;OR</item><item>twice daily: use 1 or 2 sprays in each nostril every 12 hours</item><item>do not use more than 4 spraysin each nostril in a 24 hour period</item></list></td></tr><tr><td>children 6 years to 11 years</td><td><list listType=\"unordered\" styleCode=\"Disc\"><item>an adult should supervise use</item><item>1 spray in each nostril every 12 hours</item><item>do not use more than 2 spraysin each nostril in a 24 hour period</item></list></td></tr><tr><td>children under 6 years</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20250502","id":"fc930f5c-a2b9-4e66-814d-ca8d68cc2d29","inactive_ingredient":["Inactive ingredients benzalkonium chloride, edetate disodium dihydrate, hypromellose, purified water, sodium citrate (dihydrate), sorbitol, sucralose"],"indications_and_usage":["Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose"],"keep_out_of_reach_of_children":["Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["ANDA216421"],"brand_name":["AZELASTINE HYDROCHLORIDE"],"generic_name":["AZELASTINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Allegiant Health"],"package_ndc":["69168-478-63","69168-478-02"],"product_ndc":["69168-478"],"product_type":["HUMAN OTC DRUG"],"route":["NASAL"],"rxcui":["1797883"],"spl_id":["fc930f5c-a2b9-4e66-814d-ca8d68cc2d29"],"spl_set_id":["3e2fdb0d-c2f5-41ab-b1cd-4fae80648112"],"substance_name":["AZELASTINE HYDROCHLORIDE"],"unii":["0L591QR10I"]},"package_label_principal_display_panel":["Principal Display Panel Azelastine hydrochloride label Azelastine hydrochloride carton Azelastine hydrochloride insert Azelastine hydrochloride insert Azelastine hydrochloride label Azelastine hydrochloride carton Azelastine hydrochloride insert Azelastine hydrochloride insert"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions/Comments Call 1-888-952-0050 (Monday-Friday 9 AM – 5 PM EST)"],"set_id":"3e2fdb0d-c2f5-41ab-b1cd-4fae80648112","spl_product_data_elements":["AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE AZELASTINE BENZALKONIUM CHLORIDE EDETATE DISODIUM HYPROMELLOSE, UNSPECIFIED WATER SODIUM CITRATE SORBITOL SUCRALOSE"],"spl_unclassified_section":["Other information store between 20°C to 25°C (68°F to 77°F). Protect from freezing keep this carton and the enclosed User Guide for important information do not use if sealed package is torn or opened"],"stop_use":["Stop use and ask a doctor if an allergic reaction, such as a skin rash, to this product occurs you have severe or frequent nosebleeds"],"version":"6","warnings":["Warnings Only for use in the nose. Do not spray in eyes or mouth. Do not use if you have if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have had recent nose ulcers or nose surgery have had nose injury that has not healed When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery you may get a bitter taste in your mouth. To help avoid this, tilt your head downward while spraying. nasal discomfort or sneezing may occur right after use do not share this bottle with anyone else as this may spread germs Stop use and ask a doctor if an allergic reaction, such as a skin rash, to this product occurs you have severe or frequent nosebleeds If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery you may get a bitter taste in your mouth. To help avoid this, tilt your head downward while spraying. nasal discomfort or sneezing may occur right after use do not share this bottle with anyone else as this may spread germs"]}