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Children's Astepro Allergy


SPL UNCLASSIFIED SECTION

Drug Facts


OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Azelastine HCl 205.5 mcg (equivalent to 187.6 mcg azelastine)


OTC - PURPOSE SECTION

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 SECTION

Warnings

Only for use in the nose. Do not spray in eyes or mouth.


OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.


OTC - ASK DOCTOR SECTION

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 SECTION

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 SECTION

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 SECTION

If pregnant or breast-feeding, ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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:

adults and children 12 years and olderThis product may be used either once or twice a day:once daily: use 2 sprays in each nostril; ORtwice 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 yearsan adult should supervise use1 spray in each nostril every 12 hoursdo not use more than 2 sprays in each nostril in a 24 hour period
children under 6 yearsdo not use
  • 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

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 SECTION

Inactive ingredients

benzalkonium chloride, edetate disodium, hypromellose, purified water, sodium citrate, sorbitol, sucralose


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