Label: GRX HICORT- hydrocortisone acetate suppository 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 11/13

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  • Drug Facts

    Each suppository contains Hydrocortisone Acetate 25mg

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  • Usage

    In inflamed hemrrhoids, post irradiation (factitial) proctitis as an adjunct in the treatement of chronic ulcerative colitis, cryptitis and other

    inflammatory condition of anorectum and pruritus ani

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  • Directions

    Detach one suppository from the strip of suppositories

    Remove wrapper before inserting into the rectum as follows hold suppository upright and carefully separate foil by inserting the tips of fingernail

    at the foil split

    Peel slowly and evenly down both sides, exposing suppository

    Avoid excessive handling of suppository which is designed to melt at body temperatures

    Insert one suppository rectally as directed in dosage and administration

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  • INACTIVE INGREDIENT

    Hydrogenated cocoglyceride

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  • Dosage and Administraion

    One suppository in the rectum morning and night for two week, in nonspecific proctitis In more severe cases, one suppository three time daily

    or two suppository twice daily in factitial proctitis, recommended therapy is six to eight weeks or less, according to response. For full prescribing information, see package insert

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  • WARNINGS

    Avoid contact with eyes

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  • STORAGE AND HANDLING

    Store at room temperature 59'-86'F (15'-30'C)

    Avoid freezing

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  • KEEP OUT OF REACH OF CHILDREN

    Keep away from children

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  • INGREDIENTS AND APPEARANCE
    GRX HICORT 
    hydrocortisone acetate suppository
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54162-015
    Route of Administration RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 0.025 g  in 2 g
    Inactive Ingredients
    Ingredient Name Strength
    HYDROGENATED COCO-GLYCERIDES  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54162-015-12 2 g in 1 BOX, UNIT-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 11/12/2013
    Labeler - GERITREX CORP (112796248)
    Registrant - GERITREX CORP (112796248)
    Establishment
    Name Address ID/FEI Business Operations
    GERITREX CORP 112796248 manufacture(54162-015)
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