Label: NASAL RELIEF 12-HOUR- oxymetazoline hydrochloride spray 

  • Label RSS
  • 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.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Oxymetazoline hydrochloride 0.05%

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  • Purpose

    Nasal decongestant

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  • Uses

    • temporary relief of nasal congestion
      • due to the common cold
      • due to hay fever or other upper respiratory allergies
      • associated with sinusitis
    • temporarily restores freer breathing through the nose
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  • Warnings

    Do not exceed recommended dosage

    This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection.

    Do not use

    • for more than 3 days

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland

    When using this product

    • frequent or prolonged use may cause nasal congestion to recur or worsen
    • do not use more than directed
    • there may be temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge
    • use only as directed as frequent or prolonged use may cause nasal congestion to recur or worsen
    • infection may spread if container is used by more than one person

    Stop use and ask a doctor if

    • symptoms persist

    If pregnant or breast feeding

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children

    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 to 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: do not use
    • To spray: squeeze the bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.
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  • Inactive ingredients

    benzalkonium chloride, dibasic sodium phosphate (anhydrous), edetate disodium (dihydrate), monobasic sodium phosphate (monohydrate), purified water, sodium chloride, sorbitol

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  • Questions?

    Call 1-866-645-2158

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Rugby Laboratories
    Livonia, MI 48150  USA

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  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    Compare to the
    active ingredient
    in Afrin ®*

    Nasal
    Decongestant
    12- Hour Spray

    Oxymetazoline
    Hydrochloride 0.05%

    Maximum Strength

    • Fast Acting
    • Up To 12 Hours Relief
    Nasal Relief Spray

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  • INGREDIENTS AND APPEARANCE
    NASAL RELIEF  12-HOUR
    oxymetazoline hydrochloride spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-5005
    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
    BENZALKONIUM CHLORIDE  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    EDETATE DISODIUM  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE  
    WATER  
    SODIUM CHLORIDE  
    SORBITOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-5005-72 1 in 1 CARTON
    1 15 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 10/29/2012
    Labeler - Rugby Laboratories (191427277)
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