Label: RHINOCORT ALLERGY- budesonide spray, metered

  • NDC Code(s): 50580-646-01, 50580-646-02, 50580-646-03
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 21, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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
    • sneezing
    • itchy nose
  • 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 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 instructions (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 carton tape imprinted with "RHINOCORT" is broken or missing or if aluminum seal under unit cap and spray tip is damaged/broken/unsealed
    • keep package and insert. They contain important information.
    • store at 20°-25°C (68°-77°F)
  • Inactive ingredients

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

  • Questions?

    call 1-800-343-7805 (toll free) or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL

    Original Prescription Strength

    NDC 50580-646-02

    RHINOCORT ®
    ALLERGY
    SPRAY

    Budesonide (glucocorticoid)
    Nasal spray, 32 mcg per spray
    Nasal Allergy Symptom Reliever

    24
    HOUR
    NON-DROWSY
    RELIEF OF

    • Nasal Congestion
    • Runny Nose
    • Itchy Nose
    • Sneezing

    120 SPRAYS
    0.285 fl oz (8.43 ml)

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    RHINOCORT ALLERGY 
    budesonide spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-646
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X) BUDESONIDE32 ug
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-646-011 in 1 CARTON01/14/201610/31/2020
    160 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:50580-646-021 in 1 CARTON01/14/2016
    2120 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:50580-646-033 in 1 PACKAGE01/14/2016
    31 in 1 CARTON
    3120 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02074601/14/2016
    Labeler - Johnson & Johnson Consumer Inc. (878046358)
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