Mometasone Furoate Spray, Metered
FDA Label NDC 58602-522

Mometasone furoate monohydrate (glucocorticoid) 50 mcg

Allergy symptom reliever

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

      ■  nasal congestion

      ■  runny nose

      ■  sneezing

      ■  itchy nose

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

■  in children under 2 years of age

■  to treat asthma

■  if you have an injury or surgery to your nose that is not fully healed

 ■  if you have ever had an allergic reaction to this product or any of the ingredients

■  have an eye infection

■  have or had glaucoma or cataracts

■  medicine for HIV infection (such as ritonavir)

■  a steroid medicine for asthma, allergies or skin rash

 ■  ketoconazole pills (medicine for fungal infection)

■  the growth rate of some children may be slower

■  stinging may occur for a few seconds right after use

■  you may start to feel relief within 12 hours and full effect after several days of regular, once-a-day use

■  do not share this bottle with anyone else as this may spread germs

■  remember to tell your doctor about all the medicines you take, including this one

■  you have, or come into contact with someone who has chickenpox, measles or tuberculosis

■  your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection.

■  you get a constant whistling sound from your nose. This may be a sign of damage inside your nose.

■  you get an allergic reaction to this product. Seek medical help right away.

■  you get new changes to your vision that develop after starting this product

■  you have severe or frequent nose bleeds

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Read insert (inside package) for how to:

         ■  prime the bottle

         ■  use the spray

         ■  clean the nozzle

■  shake well before each use

■  use this product only once a day

■  do  not use more than directed

Adults & children 12 years of age and older

■  2 sprays in each nostril once daily while sniffing gently

Children 2 to 11 years of age

■  the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year.

■  an adult should supervise use

■  1 spray in each nostril once daily while sniffing gently

Children under 2 years of age

■  do not use

■ do not use if sealed carton is torn or opened

■ keep package and insert. They contain important information.

■ store between 20° to 25°C (68° to 77°F)

benzalkonium chloride, citric acid monohydrate, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, sodium citrate (dihydrate)

Call toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Mometasone Furoate Nasal Spray

50 mcg per spray

24HR ALLERGY

A GETTING STARTED

Mometasone Furoate Nasal Spray works best at relieving your allergy symptoms when you get a full dose. Here’s how to get started, in five easy steps.

1 SHAKE

Figure (Mometasone Fig1)

Shake spray bottle well.

Figure (Mometasone Fig2)

Remove cap.     
                   
2 PRIME 

Do this when:

• Starting a new bottle                                           
• Bottle has not been used in one week
• Just cleaned nozzle

Otherwise go to step 3 

 



Figure (Mometasone Fig3)




Aim away from face. Grasp spray bottle as shown. Pump until fine mist appears.

Pumped ten times and still no mist?




Spray nozzle may be clogged. See KEEP IT CLEAN, other side.

NOTE:  There is enough medicine in the bottle to allow for priming sprays plus the number of sprays labeled on the bottle.

3 BLOW




Figure (Mometasone Fig4)


Blow nose gently to clear nostrils.

4 AIM



Figure (Mometasone Fig5)


Close one nostril and put tip of spray nozzle in other nostril.




Figure (Mometasone Fig6)


Put just the tip into your nose.




Figure (Mometasone Fig7)


Aim slightly away from center of nose.

5 BREATH AND SPRAY



Figure (Mometasone Fig8)


While sniffing gently, press down on spray nozzle once or twice (according to dosing instructions). You’ll feel a light mist in your nose. Breathe out through your mouth.

Repeat in other nostril.

Wipe spray nozzle with clean tissue and replace cap.
 
B DIRECTIONS FOR USE

Mometasone Furoate Nasal Spray works best when you use it daily. Here’s how to get started.

Children age 2 to 11



Figure (Mometasone Fig9)


An adult should supervise use
Use one spray in each nostril once daily.

Check with your child’s doctor
if child needs to use Mometasone Furoate Nasal Spray for longer than two months a year.

Users age 12 or older





Figure (Mometasone Fig10)


Use two sprays in each nostril every day.     




Figure (Mometasone Fig11)


 WARNING: 
Do not spray in your eyes. Only for use in your nose.  
                                                 
Other important information for use
•    Do not use more than directed.
•    If you forget a dose, do not double the next dose.
•    Do not spray into eyes or mouth.
•    If you get the spray in your eyes, rinse well with water.
•    If allergy symptoms do not improve after one week, stop using and talk to a doctor.  
•    Do not share this bottle with anyone else as this may spread germs.


C KEEP IT CLEAN
A clean spray nozzle helps ensure a full dose.
Clean it weekly, or if it’s clogged. Don’t try to unblock nozzle with pin or sharp object – that can damage it.




Figure (Mometasone Fig12)


Remove spray nozzle by grasping at base and pulling up.                                                                                        



Figure (Mometasone Fig13)


Rinse under running tap water, and dry at room temperature.




Figure (Mometasone Fig14)


Aim away from your face and gently, but firmly, replace spray nozzle.                                         




Figure (Mometasone Fig15)


If spray nozzle is clogged, soak in warm water. Then repeat steps 2 and 3.

Questions or comments? Call toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Store between 20° to 25°C (68° to 77°F).

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: AP/DRUGS/04/2016

AUROHEALTH

NDC 58602-522-44

Mometasone Furoate
Nasal Spray

50 mcg per spray

ALLERGY SYMPTOM RELIEVER
(GLUCOCORTICOID)
                                      
120
SPRAYS   0.57 FL. OZ. (17 mL)

Package Label-principal Display Panel (Container Label (120 Sprays 0.57 FL.OZ. (17 mL)))

AUROHEALTH

NDC 58602-522-44
#compare to the active ingredient in
NASONEX_TM 24HR ALLERGY

non-drowsy / scent-free mist

Mometasone Furoate
Nasal Spray
50 mcg per spray

ALLERGY SYMPTOM RELIEVER
(GLUCOCORTICOID)*

ALLERGY + CONGESTION

FULL PRESCRIPTION STRENGTH  

                                      
24HR RELIEF of:

nasal congestion / runny nose
sneezing / itchy nose

*Mometasone Furoate is a steroid
medicine known as a glucocorticoid

120
SPRAYS   0.57 FL. OZ. (17 mL)

Package Label-principal Display Panel (Container Carton Label (120 Sprays 0.57 FL.OZ. (17 mL)))