Label: HEMORRHOIDAL- cocoa butter, phenylephrine hcl suppository

  • 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 December 28, 2019

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

  • Active ingredients (in each suppository)

    Cocoa butter 88.44%

    Phenylephrine HCl 0.25%

  • Purposes

    Protectant

    Vasoconstrictor

  • 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. (1-800-222-1222)

  • 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

    Other information

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

    methylparaben, propylparaben, topical starch

    Questions or comments?

    1-800-632-6900

  • Package/Label Principal Display Panel

    COMPARE TO the active ingredients of PREPARATION H® HEMORRHOIDAL SUPPOSITORIES

    See back panel

    OUR PHARMACIST RECOMMENDED

    Hemorrhoidal Suppositories

    Reduces Internal Swelling

    Prompt Soothing Relief from Painful Burning, Itching & Discomfort

    Shrinks Swollen Hemorrhoidal Tissue

    Protects Irritated Tissue

    Also for Nighttime Relief

    24 SUPPOSITORIES

    hemorrhoidal suppositories image
  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL 
    cocoa butter, phenylephrine hcl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-279
    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 HYDROCHLORIDE6.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOW (light) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-279-6224 in 1 CARTON08/23/2014
    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 finalpart34608/23/2014
    Labeler - Kroger Company (006999528)