Label: COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL suppository

  • Category: HUMAN OTC DRUG LABEL

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 20, 2009

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  • ACTIVE INGREDIENTS

    Cocoa butter, 85.5%

    Phenylephrine HCI, 0.25%

    Shark liver oil, 3.0%

  • PURPOSE

    protectant

    vasoconstrictor

    protectant

  • USES

    • temporarily shrinks hemorrhoidal tissue
    • temporarily relieves itching burning and discomfort associated with hemorrhoids
  • WARNINGS

    For rectal use only.


    Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • difficulty in urination due to enlargement of the prostate gland
    • high blood pressure
    • diabetes

    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.

    Stop use and ask a doctor if

    • you experience bleeding
    • condition worsens or does not improve within 7 days.
    These may be signs of a serious condition.


    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.

  • DIRECTIONS

    Adults:
    • When practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue. Gently dry by patting or blotting with toilet tissue or soft cloth before insertion of this product.
    • Detach one suppository from strip
    • Remove wrapper before inserting into rectum
    • Hold suppository with rounded end up and insert tip of fingernail at end marked "peel down"
    • Carefully peel film slowly and evenly down both sides to expose 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:  ask a doctor
  • SPL UNCLASSIFIED SECTION


  • STORAGE

    Store in a cool place or at room temperature but not over 86° F.
  • INACTIVE INGREDIENTS

    methylparaben, propylparaben, starch
  • QUESTIONS


  • PACKAGE INFORMATION

    NDC 50730-1481-1
    Cat. No. 10-14812

    TRIAD®

    HEMORRHOIDAL
    SUPPOSITORIES

    Temporarily relieves itching and discomfort associated with hemorrhoids
    Individually wrapped unit dose

    12 suppositories

    Triad Group, Inc.
    Brookfield, WI 53045 USA

    FOR YOUR SAFETY, SUPPOSITORIES ARE PACKAGED IN TAMPER-EVIDENT SEALED PLASTIC WRAPPER.
    DO NOT USE IF PLASTIC WRAPPER IS TORN OR OPEN.

    carton

  • INGREDIENTS AND APPEARANCE
    COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL 
    cocoa butter, phenylephrine hydrochloride, shark liver oil suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-1481
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    cocoa butter (UNII: 512OYT1CRR) (cocoa butter - UNII:512OYT1CRR) cocoa butter2077 mg
    phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) phenylephrine hydrochloride6 mg
    shark liver oil (UNII: 4B24275HEU) (shark liver oil - UNII:4B24275HEU) shark liver oil73 mg
    Inactive Ingredients
    Ingredient NameStrength
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    starch, corn (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-1481-112 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/06/2004
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
    Registrant - H and P Industries, Inc. dba Triad Group (050259597)
    Establishment
    NameAddressID/FEIBusiness Operations
    H and P Industries, Inc. dba Triad Group050259597manufacture
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