Label: PHENYLEPHRINE HYDROCHLORIDE 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 7, 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 50730-4812-0

    Live Better

    Hemorrhoidal
    Suppositories
    PHENYLEPHRINE HCL 0.25%

    • Temporary relief of burning, itching and discomfort
    • Provides nighttime relief
    • Shrinks swelling of irritated hemorrhoidal tissue
    • Protects irritated tissue
    • Easy to open
    12 Suppositories

    DISTRIBUTED BY OMNIPOINT, INC.
    2 PARAGON DRIVE, MONTVALE, NJ 07654
    2009 ALL RIGHTS RESERVED

    Live Better products provide a simple way to look after yourself
    and your family. All of our products are crafted from high quality
    ingredients to exacting standards.
    Live Better is a great way to meet the health needs of your busy
    lifestyle. Live Better helps you be better.
    Live Better, for life.


    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
    PHENYLEPHRINE HYDROCHLORIDE 
    phenylephrine hydrochloride suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-4812
    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:50730-4812-012 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/01/2009
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
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