Nasonex

Manufacturer
Sixarp, LLC
Effective date
2025-09-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:14:14

Label at a glance#

ProductNasonex
Active ingredientMOMETASONE FUROATE MONOHYDRATE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose

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 short...

Label contents#

Full prescribing information#

Active ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Mometasone furoate monohydrate (glucocorticoid) 50 mcg

Purpose

OTC - PURPOSE SECTION

Allergy symptom reliever

Uses

INDICATIONS & USAGE SECTION

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

  • nasal congestion
  • runny nose
  • sneezing
  • itchy nose

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • have an eye infection
  • have or had glaucoma or cataracts

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-864-9649

Consumer Information Leaflet

SPL UNCLASSIFIED SECTION

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-1

Shake spray bottle well.

shake-2
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
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-1

Blow nose gently to clear nostrils.

4 – AIM

aim-1
aim-1

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

aim-2
aim-2

Put just the tip into your nose.

aim-3
aim-3

Aim slightly away from center of nose.

5 – BREATHE AND SPRAY

breathe-1
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
children-1

An adult should supervise use

Use one spray in each nostril once daily.

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

children-2
children-2

WARNING:

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

Users age 12 or older

users-1
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 notdouble 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
keep-it-clean-1

Remove spray nozzle by grasping at base and pulling up.

keep-it-clean-2
keep-it-clean-2

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

keep-it-clean-3
keep-it-clean-3

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

keep-it-clean-4
keep-it-clean-4

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

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

THREE 144 SPRAY BOTTLES

0.66 FL. OZ. (19.5 mL) EACH

3 x 144 SPRAYS

cartoncartonnasonex-dflnasonex-dflnasonex-outer-stretchcardnasonex-outer-stretchcard

DailyMed Product Concepts#

Product concept, Relation, Version table
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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3f2b3fe4-cacd-26fc-e063-6294a90a1b6c30507dfb-c5a4-4e27-e063-6294a90aa87e2025-09-19WarningsExact identifier
spl id: 3f2b3fe4-cacd-26fc-e063-6294a90a1b6c
spl set id: 30507dfb-c5a4-4e27-e063-6294a90aa87e

Reported adverse events (FAERS/openFDA)#

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