Label: MAJOR NASAL DECONGESTANT- oxymetazoline hydrochloride spray

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

Drug Label Information

Updated December 14, 2023

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

  • Drug facts 

  • Active Ingredient 

    Oxymetazoline 0.05%

  • Purpose 

    Nasal Decongestant

  • Uses

    Temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiroty allergies
    • temporarily relieves sinus congestion and pressure
    • Shrinks swollen membranes so you can breathe more freely
  • Warnings

  • Ask a Doctor before use if you have 

    • heart diease
    • high blood pressure
    • diabetes
    • thyiod diease
    • trouble urinating due to enlarged rostate 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

  • if pregnant 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 

    • Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
    • Wipe nozzle clean after use.
    • 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.
  • Other information 

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

    Benzalkonium Chloride, Disodium EDTA, Glycerin, Microcrystalline Cellulose and Carboxymethylcellulose Sodium, Polyethylene Glycol 300, Povidone, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic

  • Questions? Call 800-222-1807

  • Principal Display Panel 

    Major ® No Drip Nasal Mist NDC 0904-7427-30
    Nasal Spray Oxymetazoline HCL 0.05%
    12 hour Nasal Spray
    1 FL OZ (30 mL)

    560110_30ml_Carton

    760110_30ml_Label
  • INGREDIENTS AND APPEARANCE
    MAJOR NASAL DECONGESTANT 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7427
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7427-301 in 1 CARTON12/31/2023
    130 mL in 1 BOTTLE, PUMP; 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)