Label: AFRIN ORIGINAL- oxymetazoline hydrochloride spray

  • NDC Code(s): 11523-1167-1, 11523-1167-2, 11523-1167-3, 11523-1167-4, view more
    11523-1167-5, 11523-1167-6
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Oxymetazoline hydrochloride 0.05%

  • Purpose

    Nasal decongestant

  • Uses

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

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • diabetes
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland

    When using this product

    • do not use more than directed
    • do not use for more than 3 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 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 often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
    • children under 6 years of age: ask a doctor.

    To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

  • Other information

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

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

  • Questions or comments?

    Call 1-800-317-2165

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    Afrin ®

    Oxymetazoline HCl Nasal Solution-Nasal Decongestant

    Original

    NASAL SPRAY

    Fast, Powerful

    Congestion

    Relief

    Colds • Allergies

    up to 12

    Hour

    Relief

    Maximum

    Strength

    #1 Doctor & Pharmacist

    Recommended Brand

    1/2 FL OZ (15 mL)

    11523-1167

  • INGREDIENTS AND APPEARANCE
    AFRIN  ORIGINAL
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-1167
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-1167-22 in 1 CARTON07/14/1975
    121 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:11523-1167-31 in 1 CARTON07/14/1975
    220 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    3NDC:11523-1167-43 in 1 CARTON07/14/1975
    330 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    4NDC:11523-1167-51 in 1 CARTON07/14/1975
    430 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    5NDC:11523-1167-61 in 1 CARTON07/14/1975
    515 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    6NDC:11523-1167-16 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/16/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/14/1975
    Labeler - Bayer HealthCare LLC. (112117283)
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