DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [WYETH CONSUMER HEALTHCARE LLC]

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  • DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [WYETH CONSUMER HEALTHCARE LLC]

DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [WYETH CONSUMER HEALTHCARE LLC]
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NDC 0573-1191-20
Set ID 9ddfb021-fa96-94a6-a413-839ce5a7e744
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number PART341
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  • ACTIVE INGREDIENT

    Oxymetazoline hydrochloride 0.05%

  • PURPOSE

    Nasal decongestant

  • USES

    •
    relieves nasal congestion due to a cold, hay fever or other respiratory allergies
    •
    shrinks swollen membranes
    •
    restores freer breathing through the nose
    •
    relieves sinus congestion and pressure
  • WARNINGS

    For intranasal use only

    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

    •
    do not exceed recommended dosage
    •
    do not use for more than 3 days
    •
    use only as directed
    •
    frequent or prolonged use may cause nasal congestion to recur or worsen
    •
    you may experience 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

    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 12 years and over: with head upright, insert nozzle in nostril. Spray quickly, firmly and sniff deeply. Spray 2 or 3 times into each nostril not more often than every 10-12 hours. Do not exceed 2 doses in any 24-hour period
    •
    children under 12 years: ask a doctor
    •
    children under 2 years: do not use
  • OTHER INFORMATION

    •
    store at 20-25°C (68-77°F)
    •
    container is filled to proper level for correct spray action
    •
    retain carton for full labeling
  • INACTIVE INGREDIENTS

    benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium, hypromellose, phosphoric acid, purified water, sodium chloride

  • QUESTIONS OR COMMENTS?

    Call weekdays from 9 AM to 5 PM EST at 1-800-535-0026

  • PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton

    Dristan®

    12
    HOUR
    NASAL
    SPRAY

    OXYMETAZOLINE HCl 0.05%
    Nasal Decongestant

    FAST ACTING

    Restores freer nasal breathing
    Relieves:

    •
    Nasal congestion due to
    colds & allergies
    •
    Sinus congestion & pressure
    •
    Swelling of nasal passages

    0.5 FL OZ (15 ml)

    PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    DRISTAN 12 HR 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-1191
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Product Characteristics
    ColorYELLOW (clear, colorless to slightly yellow liquid) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-1191-201 in 1 CARTON01/01/200406/22/2021
    115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2004
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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