Label: MAJOR NASAL DECONGESTANT- oxymetazoline hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2023

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

View All Sections
  • Drug Fact 

  • Active Ingredient 

    Oxymetazoline HCL 0.05%

  • Purpose 

    Nasal Decongestant

  • Uses

    Temporarily relieves nasal congestion due to:

    • common cold
    • hay fever
    • sinusitis
    • upper respiratory allergies
    • shrinks swollen membranes so you can breathe more freely
  • Warnings 

  • Ask a Doctor before use if you have 

    • heart diease
    • high blood pressure
    • diabetes
    • thyroid disease
    • trouble urinating due to enlarged prostate gland
  • When using this product 

    Do not use more than directed
    • do not use for more than three days, Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
    • temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur.
    • use of this container by more than one person may spread infection.
  • Stop use and ask a doctor if

    Symptoms persist

  • PREGNANCY OR BREAST FEEDING

    ask a health professional before use.

  • Keep out of the reach of children

    if swallowed, get medical help or contact a Poison Control Center right away.

  • Directions 

    • Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
    • Children under 6 years of age consult a doctor.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.
  • Other information 

    • store between 20° and 25°C (68° to 77°F)
    • retain carton for future reference on full labeling
  • Inactive ingredients 

    benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

  • Principal Display Panel 

    Major© Original Nasal Spray NDC 0904-7435-35
    Oxymetazoline Hydrochloride 0.05%
    12 hour Nasal Mist Nasal Decongestant
    1/2 FLOZ (15ML)

    760100_15ml_FrontLabel

    7496599_15ml_Carton

    760101_15ml_BackLabel

  • INGREDIENTS AND APPEARANCE
    MAJOR NASAL DECONGESTANT 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7435
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POVIDONE (UNII: FZ989GH94E)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7435-351 in 1 CARTON12/31/2023
    115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/31/2023
    Labeler - Major Pharmaceuticals (191427277)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!