Label: ANEFRIN NASAL EXTRA MOISTURIZING- oxymetazoline hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 01/13

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

  • Active ingredient

    Oxymetazoline HCl 0.05%

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  • Purpose

    Nasal decongestant

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  • Uses

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

    Ask a doctor before use if you have

    heart disease
    thyroid disease
    high blood pressure
    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.

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  • 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.

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  • Other information

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

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

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  • Questions?

    1-800-719-9260

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  • Principal Display Panel

    EXTRA MOISTURIZING

    Anefrin Nasal Spray

    Oxymetazoline HCl 0.05%

    Nasal Decongestant

    Clears stuffy noses fast

    Soothes as it relieves

    12 HOUR

    Compare to Afrin® Extra Moisturizing active ingredient

    Anefrin Nasal Spray Carton Image 1
    Anefrin Nasal Spray Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    ANEFRIN NASAL  EXTRA MOISTURIZING
    oxymetazoline hcl spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0065
    Route of Administration NASAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE 0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    EDETATE DISODIUM  
    GLYCERIN  
    POLYETHYLENE GLYCOLS  
    POVIDONES  
    PROPYLENE GLYCOL  
    WATER  
    SODIUM PHOSPHATE, DIBASIC  
    SODIUM PHOSPHATE, MONOBASIC  
    BENZYL ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0065-10 1 in 1 CARTON
    1 30 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/01/1994
    Labeler - Walgreen Company (008965063)
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