Label: AFRIN NO DRIP SEVERE CONGESTION- oxymetazoline hydrochloride spray, metered

  • NDC Code(s): 11523-1350-1, 11523-1350-2, 11523-1350-3, 11523-1350-4
  • Packager: Bayer HealthCare LLC
  • Category: HUMAN OTC DRUG LABEL

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
    • thyroid disease
    • diabetes
    • 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.

    Shake well before use. Before using the first time, remove the protective cap from the tip and prime metered 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 nostril. Fully depress rim with a firm, even stroke and sniff deeply. 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, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

  • Questions or comments?

    Call 1-800-317-2165

  • SPL UNCLASSIFIED SECTION


    Bayer HealthCare LLC, Whippany, NJ, USA, 07981

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    11523-1350Oxymetazoline HCl Nasal Solution-Nasal Decongestant

    Afrin®

    NoDrip

    Won't drip from nose or down throat

    Severe Congestion

    PUMP MIST

    Fast, Powerful

    Congestion

    Relief

    Colds • Allergies

    up to 12
    Hour
    Relief

    Maximum
    Strength
    plus Menthol

    #1 Doctor & Pharmacist
    Recommended Nasal Spray Brand

    1/2 FL OZ (15 mL)

  • INGREDIENTS AND APPEARANCE
    AFRIN NO DRIP  SEVERE CONGESTION
    oxymetazoline hydrochloride spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-1350
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    MENTHOL (UNII: L7T10EIP3A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-1350-11 in 1 CARTON08/31/2000
    115 mL in 1 BOTTLE, PUMP; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:11523-1350-22 in 1 CARTON08/31/2000
    220 mL in 1 BOTTLE, PUMP; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:11523-1350-43 in 1 CARTON12/02/2022
    320 mL in 1 BOTTLE, PUMP; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    4NDC:11523-1350-32 in 1 CARTON12/02/2022
    415 mL in 1 BOTTLE, PUMP; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/31/2000
    Labeler - Bayer HealthCare LLC (112117283)
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