Label: HEMORRHOIDAL- cocoa butter, phenylephrine hydrochloride and shark liver oil suppository 

  • 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 10/12

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

  • Active ingredients (in each suppository)

    Cocoa butter 85.5%

    Phenylephrine HCl 0.25%

    Shark liver oil 3%

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  • Purpose

    Protectant

    Vasoconstrictor

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  • Uses

    temporarily

    shrinks hemorrhoidal tissues
    relieves itching, burning and discomfort associated with hemorrhoids
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  • Warnings

    For rectal use only

    Ask a doctor before use if you have

    heart disease
    high blood pressure
    diabetes
    thyroid disease
    trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    now taking a prescription drug for high blood pressure or depression

    When using this product

    do not use more than the recommended daily dosage

    Stop use and ask a doctor if

    bleeding occurs
    condition gets worse 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 right away.

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  • Directions

    children under 12 years of age: ask a doctor
    Adults:
    if possible, clean the affected area by patting or blotting with an appropriate cleansing pad
    gently dry by patting or blotting with toilet tissue or a soft cloth before insertion of this product
    detach one suppository from strip
    remove wrapper before inserting into the rectum
    hold suppository with rounded end up and carefully peel film slowly and evenly down both sides to expose suppository
    insert one suppository into rectum up to 4 times daily especially at night and morning or after each bowel movement
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  • Other information

    store at room temperature but not over 89°F (32°C)

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  • Inactive ingredients

    methylparaben, propylparaben, starch

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to the active ingredients of Preparation H® Suppositores

    HEMORRHOIDAL SUPPOSITORIES

    Prevents Further Irritation

    Helps Shrink Swelling of Irritated Hemorrhoidal Tissues

    Gives Prompt Temporary Relief From The Painful Burning, Itching and Discomfort of Hemorrhoids

    E-Z Open Wrapper

    Hemorrhoidal Suppositories Carton Image 1
    Hemorrhoidal Suppositories Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL 
    cocoa butter, phenylephrine hcl, shark liver oil suppository
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37808-394
    Route of Administration RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    COCOA BUTTER (COCOA BUTTER) COCOA BUTTER 2137.5 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 75 mg
    SHARK LIVER OIL (SHARK LIVER OIL) SHARK LIVER OIL 6.375 mg
    Inactive Ingredients
    Ingredient Name Strength
    METHYLPARABEN  
    PROPYLPARABEN  
    Product Characteristics
    Color YELLOW (opaque) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37808-394-62 4 in 1 CARTON
    1 6 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 04/15/1998
    Labeler - H E B (007924756)
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