FDA Label for Azelastine Hydrochloride
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE IF YOU HAVE
- ASK A DOCTOR BEFORE USE IF YOU
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREASTFEEDING,
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS/COMMENTS
- PRINCIPAL DISPLAY PANEL
Azelastine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Allegiant Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)
Purpose
Antihistamine
Use(S)
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- nasal congestion
- runny nose
- sneezing
- itchy nose
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.
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
- 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
- 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
| adults and children 12 years and older | This product may be used either once or twice a day: |
| children 6 years to 11 years | |
| children under 6 years | do not use |
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
Inactive Ingredients
benzalkonium chloride, edetate disodium dihydrate, hypromellose, purified
water, sodium citrate (dihydrate), sorbitol, sucralose
Questions/Comments
Call 1-888-952-0050
(Monday-Friday 9 AM – 5 PM EST)
Principal Display Panel
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