Scribd Logo
Upload

Welcome to Scribd!

  • 11 views

    20230426

    Uploaded by

    Phuong Dang

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    20230426

    Uploaded by

    Phuong Dang
    11 views12 pages

    Original Title

    20230426_13696a8b-366a-4a5e-adea-d5b7bff9e46f

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    11 views12 pages

    20230426

    Uploaded by

    Phuong Dang

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 12

    NASONEX- mometasone furoate spray

    L. Perrigo Company
    ----------
    Nasonex® 24HR Allergy Drug Facts

    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 spray bottle well.


    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

    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 nose gently to clear nostrils.


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

    Put just the tip into your nose.

    Aim slightly away from center of nose.


    5 – BREATHE AND SPRAY

    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

    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.

    WARNING:
    Do not spray in your eyes. Only for use in your nose.
    Users age 12 or older

    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.

    Remove spray nozzle by grasping at base and pulling up.

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


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

    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
    mometasone furoate spray

    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-1720

    Route of Administration NASAL

    Active Ingredient/Active Moiety


    Basis of
    Ingredient Name Strength
    Strength
    MOMETASONE FUROATE MONOHYDRATE (UNII: MTW0WEG809) (MOMETASONE - MOMETASONE
    50 ug
    UNII:8HR4QJ6DW8) FUROATE
    Inactive Ingredients
    Ingredient Name Strength
    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: 6OZ P39Z G8H)
    WATER (UNII: 059QF0KO0R)
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

    Packaging
    Marketing Start Marketing End
    # Item Code Package Description
    Date Date
    NDC:0113-
    1 1 in 1 PACKAGE 06/29/2022 06/29/2022
    1720-01
    30 in 1 BOTTLE, SPRAY; Type 0: Not a Combination
    1
    Product
    NDC:0113-
    2 1 in 1 PACKAGE 06/29/2022
    1720-11
    60 in 1 BOTTLE, SPRAY; Type 0: Not a Combination
    2
    Product
    NDC:0113-
    3 1 in 1 PACKAGE 06/29/2022
    1720-02
    120 in 1 BOTTLE, SPRAY; Type 0: Not a
    3
    Combination Product
    NDC:0113-
    4 1 in 1 PACKAGE 06/29/2022 06/29/2022
    1720-03
    72 in 1 BOTTLE, SPRAY; Type 0: Not a Combination
    4
    Product
    NDC:0113-
    5 2 in 1 PACKAGE 06/29/2022
    1720-06
    120 in 1 BOTTLE, SPRAY; Type 0: Not a
    5
    Combination Product
    NDC:0113-
    6 1 in 1 PACKAGE 06/29/2022 06/29/2022
    1720-04
    144 in 1 BOTTLE, SPRAY; Type 0: Not a
    6
    Combination Product
    NDC:0113-
    7 2 in 1 PACKAGE 06/29/2022 06/29/2022
    1720-05
    144 in 1 BOTTLE, SPRAY; Type 0: Not a
    7
    Combination Product

    Marketing Information
    Marketing Application Number or Monograph Marketing Start Marketing End
    Category Citation Date Date
    NDA NDA215712 06/29/2022

    Labeler - L. Perrigo Company (006013346)


    Revised: 2/2023 L. Perrigo Company

    You might also like