Label: HEMORRHOIDAL- cocoa butter and phenylephrine hydrochloride 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 03/13

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

  • Active ingredients (in each suppository)

    Cocoa butter 85.39%

    Phenylephrine HCl 0.25%

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  • Purposes

    Protectant

    Vasoconstrictor

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  • Uses

    helps relieve the local itching and discomfort associated with hemorrhoids
    temporarily relieves burning and shrinks hemorrhoidal tissue
    temporarily provides a coating for relief of anorectal discomforts
    temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
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  • Warnings

    For rectal use only

    Ask a doctor before use if you have

    heart disease
    high blood pressure
    thyroid disease
    diabetes
    difficulty in urination due to enlargement of the prostate 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 exceed the recommended daily dosage unless directed by a doctor

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

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  • Directions

    adults: 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 this product.
    detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
    hold suppository with rounded end up
    see illustrations: carefully separate foil tabs by inserting tip of fingernail at end marked “peel down”
    slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository
    remove exposed suppository from wrapper
    insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement
    children under 12 years of age: ask a doctor
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  • Other information

    store at 20-25°C (68-77°F)
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  • Inactive ingredients

    corn starch, methylparaben, propylparaben, shark liver oil

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  • Questions or comments?

    1-800-719-9260

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  • Package/Label Principal Display Panel

    Compare to Preparation H® Hemorrhoidal Suppositories active ingredients

    Hemorrhoidal Suppositories

    Reduces Internal Swelling. Soothes and Protects.

    E-Z Open Wrapper

    Prompt Soothing Relief from Painful Burning, Itching and Discomfort

    Protects Irritated Tissue

    Also for Night-time Relief

    Shrinks Swollen Hemorrhoidal Tissue

    Hemorrhoidal Suppositories Carton Image 1
    Hemorrhoidal Suppositories Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL 
    cocoa butter, phenylephrine hcl suppository
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42507-160
    Route of Administration RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    COCOA BUTTER (COCOA BUTTER) COCOA BUTTER 2.135 g  in 2.5 g
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE .0065 g  in 2.5 g
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    METHYLPARABEN  
    PROPYLPARABEN  
    SHARK LIVER OIL  
    Product Characteristics
    Color YELLOW Score     
    Shape BULLET Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-160-53 2 in 1 CARTON
    1 15 g in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 03/11/2013
    Labeler - HyVee Inc (006925671)
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