Label: PREFERRED PLUS 12 HOUR 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 07/13

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

  • Active ingredient

    Oxymetazoline Hydrochloride, 0.05%

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  • Purpose

    Nasal Decongestant

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  • ´╗┐Uses

    • Temporarily relieves nasal decongestion due to:  common cold, hay fever, sinusitis, upper respiratory allergies
    • Shrinks swollen nasal membranes so you can breathe more freely
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  • Warnings
  • As a doctor before use if you have

    • Heart disease
    • High blood pressure
    • Diabetes
    • Thyroid disease
    • Trouble urinating due to an enlarged prostate gland
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  • 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.
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  • STOP USE

    Stop use and ask a doctor if symptoms persists.

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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

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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 backwards while spraying.  Wipe nozzle clean after use
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  • Other information

    • Store between 20° - 25° C (68° - 77° F)
    • Retain carton for future reference on full labeling.
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  • Inactive ingredients

    Benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

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  • INGREDIENTS AND APPEARANCE
    PREFERRED PLUS 12 HOUR NASAL  EXTRA MOISTURIZING
    oxymetazoline hydrochloride spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61715-047
    Route of Administration NASAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE 50.0 mg  in 100.0 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE  
    EDETATE DISODIUM ANHYDROUS  
    GLYCERIN  
    POLYETHYLENE GLYCOL 3350  
    POVIDONE  
    PROPYLENE GLYCOL  
    SODIUM PHOSPHATE, DIBASIC  
    SODIUM PHOSPHATE, MONOBASIC  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61715-047-02 1 in 1 CARTON
    1 NDC:61715-047-01 30 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/31/2008
    Labeler - Kinray (012574513)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    Name Address ID/FEI Business Operations
    Kinray 012574513 label(61715-047)
    Establishment
    Name Address ID/FEI Business Operations
    Lee Pharmaceuticals 056425432 pack(61715-047)
    Establishment
    Name Address ID/FEI Business Operations
    Samson Pharmaceuticals 088169581 manufacture(61715-047)
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