Label: BUDESONIDE spray, metered

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 16, 2025

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  • 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).

  • Direction

    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


  • Other information

    • do not use if carton is opened, torn or broken or shows any signs of tampering.
    • 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

    CVS Pharmacy NDC 69842-001-01

    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

    CVS Pharmacy NDC 69842-001-01

    Budesonide Nasal Spray

    Allergy Spray

    120 sprays

    Bottle-label
  • INGREDIENTS AND APPEARANCE
    BUDESONIDE 
    budesonide spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-001
    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 (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:69842-001-011 in 1 BOTTLE, SPRAY07/01/2025
    1120 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
    ANDAANDA07894907/01/2025
    Labeler - CVS Pharmacy (062312574)
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