COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [CVS]

COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [CVS]
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NDC 59779-401-44, 59779-401-45, 59779-401-46
Set ID 79aba427-9500-4689-a2a3-c8128eb08398
Category HUMAN OTC DRUG LABEL
Packager CVS
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART346
  • ACTIVE INGREDIENT

    Active ingredients (in each suppository)                                  Purpose


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


  • 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

  • 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.
  • INDICATIONS & USAGE

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

  • 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)
  • INACTIVE INGREDIENT

    Inactive Ingredients starch, shark liver oil, methylparaben, propylparaben
  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE 
    cocoa butter, phenylephrine hydrochloride suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-401
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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 NameStrength
    SHARK LIVER OIL (UNII: 4B24275HEU)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-401-4430 g in 1 BOX
    2NDC:59779-401-4560 g in 1 BOX
    3NDC:59779-401-46120 g in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/01/2011
    Labeler - CVS (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture

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