Azelastine Hydrochloride
205.5 ug · Spray, Metered
- Available without prescription
- Histamine-1 Receptor Antagonist
- Active substance
- Azelastine Hydrochloride
- Made by
- Aurohealth LLC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2026-08-20
Antihistamine
- Nasal congestion
- Runny nose
- Sneezing
- Itchy nose
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
Full directions ↓If you have ever had an allergic reaction to this product or any of its ingredients
All warnings ↓- Sold without a prescription
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- nasal congestion
- runny nose
- sneezing
- itchy nose
From the official label · 2026-08-20 · DailyMed
How it works
From the US prescribing label for the same active substance (Azelastine). It describes the substance, not this exact product.
Azelastine hydrochloride, a phthalazinone derivative, exhibits histamine H 1 -receptor antagonist activity in isolated tissues, animal models, and humans.
Azelastine HCl Nasal Spray is administered as a racemic mixture with no difference in pharmacologic activity noted between the enantiomers in in vitro studies.
Azelastine is oxidatively metabolized to the principal active metabolite, desmethylazelastine, by the cytochrome P450 enzyme system.
Approximately 75% of an oral dose of radiolabeled azelastine hydrochloride was excreted in the feces with less than 10% as unchanged azelastine.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-03-26
Do not take it if
if you have ever had an allergic reaction to this product or any of its ingredients
Quoted from the official label, section “OTC — Do Not Use”.
How to take it
These directions are for this exact strength and form. Another one is different.
- 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 sprays in 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 sprays in each nostril in a 24 hour period
- children under 6 years
- do not use
Quoted from the official label, section “Dosage & Administration”.
Ask a doctor first if
- you
- have had recent nose ulcers or nose surgery
- have had a nose injury that has not healed
Quoted from the official label, section “OTC — Ask Doctor”.
Stop and get help if
- an allergic reaction, such as a skin rash, to this product occurs
- you have severe or frequent nosebleeds
Quoted from the official label, section “OTC — Stop Use”.
Other warnings
- Only for use in the nose. Do not spray in eyes or mouth.
- 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
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Keep away from children
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Quoted from the official label, section “OTC — Keep Out of Reach of Children”.
How to store it
- store between 20° to 25°C (68° to 77°F). Protect from freezing. keep this carton and the enclosed User Guide for important information
- do not use if seal printed with “sealed for your protection” on top and bottom carton flaps is not intact.
Quoted from the official label, section “Storage and Handling”.
What kind of medicine it is
Antihistamine
Quoted from the official label, section “OTC — Purpose”.
Other ingredients
Relevant if you react to a dye, a preservative, lactose or gluten.
- benzalkonium chloride, edetate disodium, hypromellose, purified water, sodium citrate (dihydrate), sorbitol and sucralose.
- Questions or comments? 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by:
- AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code:
- AP/DRUGS/04/2016
Quoted from the official label, section “Inactive Ingredients”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
- Sugar alcohols
sorbitol
Sorbitol and similar can upset the stomach and matter with fructose intolerance.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (8)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 8 of 8
- Azelastine HydrochlorideThis oneWithout prescriptionAurohealth LLCSugar alcohols
- Azelastine HydrochlorideWithout prescriptionAllegiant HealthSugar alcohols
- Azelastine HclWithout prescriptionAmneal Pharmaceuticals NY LLCSugar alcohols
- Astepro AllergyWithout prescriptionBayer HealthCare LLC.Sugar alcohols
- Children Astepro AllergyWithout prescriptionBayer HealthCare LLC.Sugar alcohols
- Azelastine HydrochlorideWithout prescriptionCVS PHARMACY, INCSugar alcohols
- Azelastine HydrochlorideWithout prescriptionWalgreensSugar alcohols
- Azelastine HydrochlorideWithout prescriptionYYBA CorpSugar alcohols
Details
| Made by | Aurohealth LLC |
|---|---|
| Active substance | Azelastine Hydrochloride |
| Used in | Breathing, airways, allergies and cough |
| Strength | 205.5 ug |
| Form | Spray, Metered |
| Route | Nasal |
| Packs | 1 BOTTLE, SPRAY in 1 CARTON / 200 SPRAY, METERED in 1 BOTTLE, SPRAY · 1 BOTTLE, SPRAY in 1 CARTON / 60 SPRAY, METERED in 1 BOTTLE, SPRAY |
| NDC | 58602-020 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
21 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Spray, Metered14 products
1 mg/mL2
1 mg/mL · 2 companies
205.5 ug5
205.5 ug · 5 companies
- Allegiant Health
- Aurohealth LLC · this page
- CVS PHARMACY, INC
- Walgreens
- YYBA Corp
- Solution/ Drops7 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.