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: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • 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 12, 2020

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

  • 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 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.

  • 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 CARTON01/05/2004
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0573-2883-2024 in 1 CARTON01/05/2004
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0573-2883-3048 in 1 CARTON01/05/2004
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0573-2883-5556 in 1 CARTON01/05/2004
    41 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:0573-2883-1112 in 1 CARTON01/05/2004
    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 FINALpart34601/05/2004
    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 CARTON01/05/2004
    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 FINALpart34601/05/2004
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)