Label: HEMORRHOIDAL- hard fat, phenylephrine hcl suppository

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 8, 2023

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  • Active Ingredients (in each suppository)

    Hard Fat 88.44%

    Phenylephrine hydrochloride 0.25%

  • Purpose

    Protectant

    Vasoconstrictor

  • Uses

    • temporarily shrinks hemorrhoidal tissue
    • gives temporary relief to the itching, burning and discomfort associated with hemorrhoids
  • Warnings

    For rectal use only

    Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • high blood pressure
    • diabetes
    • trouble urinating due to an enlargedprostate gland

    Ask a doctor or pharmacist before use if you are

    presently taking a prescription drug for high blood pressure or depression

    When using this product,

    do not use more than directed

    Stop use and ask a doctor if

    • bleeding occurs
    • condition worsens or does not improve within 7 days

    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 (1-800-222-1222) right away.

  • Directions

    • when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.
    • gently dry by patting or blotting with a tissue or a soft cloth before insertion of suppository.
    • detach on suppository from the strip
    • separate the two tabs of the white plastic wrap
    • with thumb and forefinger of each hand, grasp the tabs and peel downward, unwrapping the suppository
    • insert one suppository into the rectum

    adults and children 12 years and over: insert one suppository rectally up to 4 times daily

    children under 12 years: ask a doctor

  • Other information

    store below 30ºC (86ºF) to avoid melting.

  • Inactive ingredients

    corn starch, methylparaben, propylparaben

  • PRINCIPAL DISPLAY PANEL

    Major Hem SuppositoriesThe product package shown above represents a sample of that currently in use. Additional packaging may also be available.

    Major Hemorrhoidal Suppositories 12ct

    Distributed by

    Major Pharmaceuticals

    17177 N. Laurel Park Drive

    Suite 233

    Livonia, MI 48152

    MajorHemSupp.jpg

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL 
    hard fat, phenylephrine hcl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6977
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HARD FAT (UNII: 8334LX7S21) (HARD FAT - UNII:8334LX7S21) HARD FAT1.77 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6977-122 in 1 CARTON12/18/2019
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01512/18/2019
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - DSC Laboratories Inc. (097807374)
    Establishment
    NameAddressID/FEIBusiness Operations
    DSC Laboratories Inc.097807374manufacture(0904-6977)
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