Label: PREPARATION H- cocoa butter, phenylephrine hydrochloride suppository

  • NDC Code(s): 0573-2880-31, 0573-2883-10, 0573-2883-11, 0573-2883-20, view more
    0573-2883-30, 0573-2883-55
  • Packager: Pfizer Consumer Healthcare
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 24, 2014

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purposes
    Cocoa butter 88.44% Protectant
    Phenylephrine HCl 0.25% Vasoconstrictor
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  • INDICATIONS & USAGE

    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.

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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
      • as shown, 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
    Figure
    Figure
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  • Other information

    store at 20-25°C (68-77°F)

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  • Inactive ingredients

    corn starch, methylparaben, propylparaben

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  • Questions or comments?

    Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374

    For most recent product information, visit www.preparationh.com
    Pfizer, Madison, NJ 07940 USA © 2011 Pfizer Inc.

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  • PRINCIPAL DISPLAY PANEL - 12 Suppository Blister Pack

    PREPARATION H®

    Hemorrhoidal Suppositories
    Wyeth Consumer Healthcare
    Madison, NJ 07940 USA

    PAA009364

    Principal Display Panel - 12 Suppository Blister Pack
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  • PRINCIPAL DISPLAY PANEL - 12 Suppository Blister Pack Carton

    PREPARATION H®

    HEMORRHOIDAL SUPPOSITORIES

    Reduces Internal Swelling, Soothes and Protects

    • Prompt Soothing Relief from Painful Burning, Itching and Discomfort
    • Shrinks Swollen Hemorrhoidal Tissue
    • Protects Irritated Tissue
    • Also for Nighttime Relief

    12 SUPPOSITORIES

    Principal Display Panel - 12 Suppository Blister Pack Carton
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  • PRINCIPAL DISPLAY PANEL - 48 Suppository Blister Pack Carton

    PREPARATION H®
    HEMORRHOIDAL
    SUPPOSITORIES

    Provides Relief from
    MULTIPLE SYMPTOMS

    Reduces Internal Swelling,
    Soothes & Protects
    Prompt Soothing Relief from
    Painful Burning, Itching and
    Discomfort
    Also for Nighttime Relief

    #1 SELLING
    #1
    • HEMORRHOID BRAND •

    48 SUPPOSITORIES

    Principal Display Panel - 48 Suppository Blister Pack Carton
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  • INGREDIENTS AND APPEARANCE
    PREPARATION H 
    cocoa butter, phenylephrine hydrochloride suppository
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-2883
    Route of Administration RECTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER 2211 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 6.25 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color YELLOW (Light yellow) Score no score
    Shape BULLET (Bullet shaped suppository) Size 150mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-2883-10 12 in 1 CARTON
    1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:0573-2883-20 24 in 1 CARTON
    2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:0573-2883-30 48 in 1 CARTON
    3 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4 NDC:0573-2883-55 56 in 1 CARTON
    4 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5 NDC:0573-2883-11 12 in 1 CARTON
    5 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part346 01/05/2004
    PREPARATION H 
    cocoa butter, phenylephrine hydrochloride suppository
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-2880
    Route of Administration RECTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER 2211 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 6.25 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color YELLOW (Light yellow) Score no score
    Shape BULLET (Bullet shaped suppository) Size 150mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-2880-31 48 in 1 CARTON
    1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part346 01/05/2004
    Labeler - Pfizer Consumer Healthcare (828831730)
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