Label: BUDESONIDE spray, metered

  • NDC Code(s): 60505-6129-2, 60505-6129-6, 60505-6129-7
  • Packager: Apotex Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 6, 2017

If you are a consumer or patient please visit this version.

  • Active ingredient (in each spray)

    Budesonide (glucocorticoid) 32 mcg

  • Purpose

    Nasal allergy symptom reliever

  • Uses

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

    • nasal congestion • runny nose • itchy nose • sneezing

  • Warnings

    Do not use

    • in children under 6 years of age
    • if you have ever had an allergic reaction to any of the ingredients

    Ask a doctor before use if you

    • have had recent nose ulcers or nose surgery
    • have had a nose injury that has not healed
    • are using a steroid medicine for asthma, allergies or skin rash
    • have an eye infection
    • have or had glaucoma or cataracts

    When using this product

    • the growth rate of some children may be slower
    • some symptoms may get better on the first day of treatment. It may take up to two weeks of daily use to feel the most symptom relief.
    • 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
    • you have or develop symptoms of an infection such as persistent fever
    • you have any change in vision
    • 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) on how to:
    • get a new bottle ready (primed) before first use
    • prime bottle again if not used for two days
    • use the spray
    • clean the spray nozzle

    ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER

    adults and children 12 years of age and older

    • once daily, spray 2 times into each nostril while sniffing gently
    • once your allergy symptoms improve, reduce to 1 spray in each nostril per day
    CHILDREN 6 TO UNDER 12 YEARS OF AGE
    • the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year
    children 6 to under 12 years of age
    • an adult should supervise use
    • once daily, spray 1 time into each nostril while sniffing gently
    • if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day
    children under 6 years of age
    • do not 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 allergy symptoms do not improve after two weeks, stop using and talk to a doctor
    • do not use for the common cold
    • shake well before each use
  • Other information

    • do not use if the safety seal labeled "sealed for your protection" is broken or missing.
    • keep package and insert. They contain important information.
    • store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light.
  • Inactive ingredients

    carboxymethyl cellulose sodium, dextrose anhydrous, edetate disodium dihydrate, hydrochloric acid (for pH adjustment), microcrystalline cellulose, polysorbate 80, potassium sorbate, purified water

  • Questions or comments?

    call toll free 1-800-706-5575

  • Principal Display Panel - Carton

    CARTON LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

    APOTEX CORP. NDC 60505-6129-2

    Budesonide Nasal Spray

    Allergy Spray

    120 sprays

    Relief of:

    • Nasal Congestion
    • Runny Nose
    • Itchy Nose
    • Sneezing

    Carton-label

  • Principal Display Panel - Bottle

    BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

    APOTEX CORP. NDC 60505-6129-2

    Budesonid Nasal Spray

    Allergy Spray

    120 sprays

    Bottle-label

  • INGREDIENTS AND APPEARANCE
    BUDESONIDE 
    budesonide spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60505-6129
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUDESONIDE (UNII: Q3OKS62Q6X) (Budesonide - UNII:Q3OKS62Q6X) BUDESONIDE32 ug
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60505-6129-21 in 1 BOTTLE, SPRAY04/19/2016
    1120 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:60505-6129-73 in 1 CARTON04/19/2016
    2120 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    3NDC:60505-6129-62 in 1 CARTON04/19/2016
    3120 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07894904/19/2016
    Labeler - Apotex Corp. (845263701)
    Registrant - Apotex Inc. (209429182)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotex Inc.255092496analysis(60505-6129) , manufacture(60505-6129)
    Establishment
    NameAddressID/FEIBusiness Operations
    Farmabios S.p.A.428680078api manufacture(60505-6129)