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: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 2, 2024

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  • Active Ingredients

    Cocoa butter 88.44%

    Phenylephrine HCl 0.25%

    Purposes

    Protectant

    Vasoconstrictor

  • 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
  • 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 arepresently taking a prescription drug for high blood pressure or depression.

    When using this productdo 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.

  • 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
  • Other information

    store at 20-25°C (68-77°F)

  • Inactive ingredients

    corn starch, methylparaben, propylparaben

  • 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.

  • PRINCIPAL DISPLAY PANEL

    NDC 0573-2883-10

    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
  • PRINCIPAL DISPLAY PANEL

    NDC 0573-2880-31

    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
  • INGREDIENTS AND APPEARANCE
    PREPARATION H 
    cocoa butter, phenylephrine hydrochloride suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2883
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER2211 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Coloryellow (Light yellow) Scoreno score
    ShapeBULLET (Bullet shaped suppository) Size150mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2883-1012 in 1 CARTON01/05/200410/31/2024
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0573-2883-2024 in 1 CARTON01/05/200410/31/2024
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0573-2883-3048 in 1 CARTON01/05/200410/31/2024
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0573-2883-5556 in 1 CARTON01/05/200410/31/2024
    41 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:0573-2883-1112 in 1 CARTON01/05/200410/31/2024
    51 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01501/05/2004
    PREPARATION H 
    cocoa butter, phenylephrine hydrochloride suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2880
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER2211 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Coloryellow (Light yellow) Scoreno score
    ShapeBULLET (Bullet shaped suppository) Size150mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2880-3148 in 1 CARTON01/05/200410/31/2024
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01501/05/2004
    Labeler - Haleon US Holdings LLC (079944263)
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