Allergy Spray, Metered
FDA Label NDC 42507-182

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hyvee Inc for the product Allergy (NDC 42507-182). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each spray), purpose, uses, warnings, do not use, ask a doctor before use if you, ask a doctor or pharmacist before use if you are taking, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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 Breast-Feeding,

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 tape printed with “sealed for your protection” on top and bottom carton flaps is not intact
  • 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 1-800-289-8343

Consumer Information

Mometasone Furoate Nasal Spray, 50 mcg/Spray

1Y800 00 J2

A GETTING STARTED

This product 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.

Shake Bottle (Image 01)

Shake Bottle (Image 01)

Remove cap.

Remove Cap (Image 02)

Remove Cap (Image 02)

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 (Image 03)

    Prime (Image 03)

  • 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.

    Blow Image (Image 04)

    Blow Image (Image 04)

    4 AIM

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

    Aim Image (Image 05)

    Aim Image (Image 05)

    Put just the tip into your nose.

    Tip Image (Image 06)

    Tip Image (Image 06)

    Aim slightly away from center of nose.

    Aim Slightly Image (Image 08)

    Aim Slightly Image (Image 08)

    5 BREATHE AND SPRAY

    While Sniffing Image (Image 11)

    While Sniffing Image (Image 11)

    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

    This product 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.

    1x Each Nostril Image (Image 07)

    1x Each Nostril Image (Image 07)

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

    WARNING:

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

    Warning Image (Image 12)

    Warning Image (Image 12)

    Users age 12 or older

    Use two sprays in each nostril every day.

    Two Times Image (Image 09)

    Two Times Image (Image 09)

    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 Nozzle Image (Image 10)

      Remove Nozzle Image (Image 10)

      Remove spray nozzle by grasping at base and pulling up.

      Rinse Image (Image 13)

      Rinse Image (Image 13)

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

      Replace Nozzle Image (Image 14)

      Replace Nozzle Image (Image 14)

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

      Soak Image (Image 15)

      Soak Image (Image 15)

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

      Questions or comments? Call toll-free 1-800-719-9260

      Store between 20°-25°C (68°-77°F)

      Distributed By

      Perrigo®

      Allegan, MI 49010

      SIDE 2

Package/Label Principal Display Panel

Hy•Vee®

Compare To Nasonex® 24HR Allergy Active Ingredient

Full Prescription Strength

Allergy Spray

Mometasone Furoate Nasal Spray, 50mcg/Spray

Allergy Symptom Reliever (Glucocorticoid)*

Scent-Free Mist

Allergy + Congestion

Non-Drowsy

24 HR

24 HOUR RELIEF OF:

• Nasal Congestion

• Runny Nose

• Sneezing

• Itchy Nose

120 SPRAYS

*Mometasone furoate is a steroid medicine known as a glucocorticoid

0.57 FL OZ (17.0 mL)

Allergy-spray (Allergy Spray)

Allergy-spray (Allergy Spray)

* Please review the disclaimer below.