12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [PREFERRED PHARMACEUTICALS INC.]

12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [PREFERRED PHARMACEUTICALS INC.]
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NDC 68788-7075-3
Set ID d3701428-011e-4318-9e67-c122fcc1d1d1
Category HUMAN OTC DRUG LABEL
Packager Preferred Pharmaceuticals Inc.
Generic Name
Product Class
Product Number
Application Number PART341
  • Drug Facts

    Active Ingredient
    Oxymetazoline Hydrochloride 0.05%

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  • Purpose

    Nasal Decongestant

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  • Uses

    Tempoarily relieves nasal congestion due to:

    common cold
    hay fever
    sinusitis
    upper respiroty allergies
    Shribnk swollen membranes so you can breathemore freely
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  • Warnings
  • Ask a Doctor before use if you have

    heart diease
    high blood pressure
    diabetes
    thyiod diease
    trouble urinating due to enlarged rostate gland.
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  • When using this product

    Do not use more than directed
    do not use for more than three days, Use onyl 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 thna one person may spread infection.
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  • stop use and ask a doctor if

    symptoms persist.

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  • SPL UNCLASSIFIED SECTION

    ask a health professional before use.

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  • Keep out of the reach of children

    if swallowed, get medical help or contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION

    Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
    Children under 6 years of age consult 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° and 25°C (68° to 77°F)
    retain carton for future reference on full labeling

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  • INACTIVE INGREDIENT

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

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  • Principal display panel- Bottle

    Nasal Decongestant 12 Hour Spray

    Lee

    Relieves Conmgestion

    Nasal Spray original 12 hour relief

    Oxymetazoline HCL Nasal SolutionNasal Decongestant

    1 FL OZ (30 ml)

    Relabeled By: Preferred Pharmaceuticals Inc.

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  • INGREDIENTS AND APPEARANCE
    12 HOUR ORIGINAL NASAL DECONGESTANT 
    nasal spray liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7075(NDC:11527-140)
    Route of Administration NASAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 50 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POVIDONE K30 (UNII: U725QWY32X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68788-7075-3 1 in 1 CARTON 01/02/2018
    1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/02/2018
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    Name Address ID/FEI Business Operations
    Preferred Pharmaceuticals Inc. 791119022 RELABEL(68788-7075)
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