Label: NASONEX- mometasone furoate spray, metered

  • NDC Code(s): 0113-1720-01, 0113-1720-02, 0113-1720-03, 0113-1720-04, view more
    0113-1720-05, 0113-1720-06, 0113-1720-07, 0113-1720-11
  • Packager: L. Perrigo Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 21, 2024

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  • Active ingredient (in each spray)

    Mometasone furoate monohydrate (glucocorticoid) 50 mcg

  • Purpose

    Allergy symptom reliever

  • Uses

    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).

  • Directions

    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

    THREE 144 SPRAY BOTTLES

    0.66 FL. OZ. (19.5 mL) EACH

    3 x 144 SPRAYS

    nasonex-pdp
    nasonex-dfl
    nasonex-outer-stretchcard
  • INGREDIENTS AND APPEARANCE
    NASONEX 
    mometasone furoate spray, metered
    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 (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 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:0113-1720-111 in 1 PACKAGE06/29/2022
    260 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:0113-1720-021 in 1 PACKAGE06/29/2022
    3120 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    4NDC:0113-1720-031 in 1 PACKAGE06/29/202206/29/2022
    472 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    5NDC:0113-1720-062 in 1 PACKAGE06/29/2022
    5120 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    6NDC:0113-1720-041 in 1 PACKAGE06/29/202206/29/2022
    6144 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    7NDC:0113-1720-052 in 1 PACKAGE06/29/202206/29/2022
    7144 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    8NDC:0113-1720-073 in 1 PACKAGE01/21/2024
    8144 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21571206/29/2022
    Labeler - L. Perrigo Company (006013346)
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