Label: HEMORRHOID RELIEF - cocoa butter, phenylephrine hydrochloride suppository

  • NDC Code(s): 11822-0450-6, 11822-0450-7, 11822-0450-8
  • Packager: Rite Aid Corporation
  • 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 July 1, 2011

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

  • ACTIVE INGREDIENT

    Active ingredients (in each suppository)                                  Purpose


    Cocoa Butter 85.5%........................................................................ Protectant
    Phenylephrine HCL 0.25%............................................................... Vasoconstrictor


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  • PURPOSE



    Active ingredients (in each suppository)                                  Purpose


    Cocoa Butter 85.5%........................................................................ Protectant
    Phenylephrine HCL 0.25%............................................................... Vasoconstrictor

    ________________________________________________________________________________________

    Uses temporarily - Shrinks hemorrhoidal tissues - relieves itching, burning and discomfort associated with hemorrhoids

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  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. If swallowed, get
    medical help or contact a Poison Control Center right away.
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  • INDICATIONS & USAGE

    Uses - shrinks hemorrhoidal tissues - relieves itching, burning and discomfort associated with hemorrhoids
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  • WARNINGS

    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
    ______________________________________________________

    Stop use and ask a doctor if
    - bleeding occurs - condition gets worse or does not improve within 7 days
    ______________________________________________________

    If pregnant or breastfeeding, 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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  • DOSAGE & ADMINISTRATION


    Directions

    - Adults - if possible, clean the affected area by patting or blotting with an appropriate cleansing pad
    - gently dry by patting or blotting with toilet tissue or a soft cloth before insertion of this product
    - detach one suppository from strip - remove wrapper before inserting into the rectum - hold suppository
    with rounded end up and carefully peel film slowly and evenly down both sides to expose the suppository
    - insert one suppository into rectum up to 4 times daily especially at night and morning or after each bowel
    movement

    Children under 12 years of age: ask a doctor
    ________________________________________________________________________________________

    Other information - store at room temperature but not over 89 degrees F (32 degrees C) Close
  • INACTIVE INGREDIENT

    Inactive Ingredients starch, shark liver oil, methylparaben, propylparaben
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  • INGREDIENTS AND APPEARANCE
    HEMORRHOID RELIEF 
    cocoa butter, phenylephrine hydrochloride suppository
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0450
    Route of Administration RECTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER .855 g  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE .0025 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    SHARK LIVER OIL (UNII: 4B24275HEU)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0450-6 12 in 1 CARTON
    1 2.5 g in 1 PACKET
    2 NDC:11822-0450-7 24 in 1 CARTON
    2 2.5 g in 1 PACKET
    3 NDC:11822-0450-8 48 in 1 CARTON
    3 2.5 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 07/01/2011
    Labeler - Rite Aid Corporation (014578892)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    Name Address ID/FEI Business Operations
    Pharma Pac, LLC 140807475 manufacture
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