FDA Label for Children Astepro Allergy
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Children Astepro Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Bayer Healthcare Llc.. 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.
Other
Drug Facts
Otc - Active Ingredient
Active ingredient
Azelastine HCl 205.5 mcg (equivalent to 187.6 mcg azelastine)
Otc - Purpose
Purpose
Antihistamine
Uses
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- nasal congestion
- runny nose
- sneezing
- itchy nose
Warnings
Warnings
Only for use in the nose. Do not spray in eyes or mouth.
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Otc - Ask Doctor
Ask a doctor before use if you
- have had recent nose ulcers or nose surgery
- have had a nose injury that has not healed
Otc - 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
Otc - 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
Directions
Read the User Guide for how to:
- prime the bottle before first use
- prime bottle again if not used for 3 or more days
- use the spray
- 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 sprays in 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 sprays in 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
Other information
- 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 tape printed with “sealed for your protection” on top and bottom carton flaps is not intact
Inactive Ingredient
Inactive ingredients
benzalkonium chloride, edetate disodium, hypromellose, purified water, sodium citrate, sorbitol, sucralose
Questions Or Comments
Questions or comments?
1-800-317-2165 (Mon-Fri, 9AM-5PM EST)
Package Label.Principal Display Panel
Azelastine HCl 205.5 mcg per spray
ANTIHISTAMINE NASAL SPRAY
FULL PRESCRIPTION STRENGTH
STEROID FREE
UP TO 24 HOUR RELIEF OF
Nasal congestion
Runny nose
Sneezing
Itchy nose
* Please review the disclaimer below.