Label: ASSURED ORIGINAL RELIEF EYE - tetrahydrozoline hydrochloride solution

  • NDC Code(s): 33992-9376-5
  • Packager: GREENBRIER INTERNATIONAL, INC.
  • 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 02/13

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

  • ACTIVE INGREDIENT

    Active ingredient                                                           Purpose

    Tetrahydrozoline HCL 0.05%.........................................Redness reliever

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  • PURPOSE

    Uses

    • for the relief of redness of the eyes due to minor eye irritations
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  • WARNINGS

    Warnings

    Ask a doctor before use if you have narrow angle glaucoma

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  • WHEN USING

    When using this product

    • pupils may become enlarged temporarily
    • overuse may cause more eye redness
    • remove contact lenses before using
    • do not use if this solution changes color or becomes cloudy
    • to avoid contamination, do not touch tip
    • replace cap after each use
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  • STOP USE

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye lasts
    • condition worsens or lasts more than 72 hours
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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 right away.

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  • INDICATIONS & USAGE

    Directions

    • put 1 to 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years of age: ask a doctor
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  • STORAGE AND HANDLING

    Other information

    • some users may experience a brief tingling sensation
    • store at 15o to 25oC (59o to 77oF)
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  • INACTIVE INGREDIENT

    Inactive ingredients: benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium borate

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  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY

    GREENBRIER INTERNATIONAL, INC.

    500 VOLVO PARKWAY

    CHESAPEAKE, VA 23320


    MADE IN KOREA
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  • INGREDIENTS AND APPEARANCE
    ASSURED ORIGINAL RELIEF EYE  
    tetrahydrozoline hydrochloride solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:33992-9376
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE 0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE  
    BORIC ACID  
    EDETATE DISODIUM  
    SODIUM CHLORIDE  
    SODIUM BORATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:33992-9376-5 1 in 1 CARTON
    1 15 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 02/28/2013
    Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
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