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Nasonex 24HR Allergy Prescribing Information

Package insert / product label
Generic name: mometasone furoate monohydrate
Dosage form: spray, metered
Drug class: Nasal steroids

Medically reviewed by Drugs.com. Last updated on Aug 24, 2023.

Active ingredient (in each spray)

Mometasone furoate monohydrate (glucocorticoid) 50 mcg

Purpose

Allergy symptom reliever

Indications and Usage for Nasonex 24HR Allergy

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

nasal congestion
runny nose
sneezing
itchy nose

Warnings

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

Do not use

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

Ask a doctor before use if you

have an eye infection
have or had glaucoma or cataracts

Ask a doctor or pharmacist before use if you are taking

medicine for HIV infection (such as ritonavir)
a steroid medicine for asthma, allergies or skin rash
ketoconazole pills (medicine for fungal infection)

When using this product

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

Stop use and ask a doctor if

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 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 (1-800-222-1222).

Nasonex 24HR Allergy Dosage and Administration

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

Other information

do not use if sealed package is torn or opened
keep package and insert. They contain important information.
store between 20-25°C (68-77°F)

Inactive Ingredients

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

Questions or comments?

Call toll-free 1-800-864-9649

Consumer Information Leaflet

NASONEX®

24HR ALLERGY

72A00 SY J2

A - GETTING STARTED

NASONEX® 24HR Allergy 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

shake-1

Shake spray bottle well.

shake-2

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

prime-1

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

blow-1

Blow nose gently to clear nostrils.

4 – AIM

aim-1

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

aim-2

Put just the tip into your nose.

aim-3

Aim slightly away from center of nose.

5 – BREATHE AND SPRAY

breathe-1

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.

Dosing and Cleaning instructions

See other side

SIDE 1

B – DIRECTIONS FOR USE

NASONEX® 24HR Allergy works best when you use it daily. Here’s how to get started.

Children age 2-11

children-1

An adult should supervise use

Use one spray in each nostril once daily.

Check with your child’s doctor if child needs to use NASONEX for longer than two months a year.

children-2

WARNING:

Do not spray in your eyes. Only for use in your nose.

Users age 12 or older

users-1

Use two sprays in each nostril every day.

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.

keep-it-clean-1

Remove spray nozzle by grasping at base and pulling up.

keep-it-clean-2

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

keep-it-clean-3

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

keep-it-clean-4

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

Questions or comments? Call toll-free 1-800-864-9649

Store between 20º-25ºC (68º-77ºF)

Nasonex, the Nasonex logo, the bottle and cap designs, and other design elements are trademarks of Organon LLC or its affiliates and used under license.

Distributed By

Perrigo®

Allegan, MI 49010

©2023. All rights reserved.

SIDE 2

Package/Label Principal Display Panel

ALLERGY CONGESTION

PERRIGO Selfcare

non-drowsy / scent-free mist

NASONEX®

24HR ALLERGY

MOMETASONE FUROATE NASAL SPRAY, 50 MCG/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. (17.0 mL)

nasonex-pdp
nasonex-dfl
NASONEX
mometasone furoate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-1720
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MOMETASONE FUROATE MONOHYDRATE (UNII: MTW0WEG809) (MOMETASONE - UNII:8HR4QJ6DW8) MOMETASONE FUROATE50 ug
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0113-1720-011 in 1 PACKAGE06/29/202206/29/2022
130 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2NDC:0113-1720-111 in 1 PACKAGE06/29/2022
260 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
3NDC:0113-1720-021 in 1 PACKAGE06/29/2022
3120 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
4NDC:0113-1720-031 in 1 PACKAGE06/29/202206/29/2022
472 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
5NDC:0113-1720-062 in 1 PACKAGE06/29/2022
5120 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
6NDC:0113-1720-041 in 1 PACKAGE06/29/202206/29/2022
6144 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
7NDC:0113-1720-052 in 1 PACKAGE06/29/202206/29/2022
7144 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21571206/29/2022
Labeler - L. Perrigo Company (006013346)