Label: HEMORRHOIDAL 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 October 16, 2014

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

  • Drug Facts

    Active Ingredients Purpose
    (per suppository)
    Cocoa butter 85.5%...............................................Protectant
    Phenylephrine hydrochloride 0.25%................Vasoconstructor

  • Uses

    temporarily shrinks hemorrhoidal tissues
    gives temporary relief to the itching,burning and
    discomfort associated with hemorrhoids
    aids in protecting irritated anorectal areas

  • Directions

    detach one suppository from the strip. Remove the wrapper
    before inserting into the rectum
    insert one suppository into the rectum up to 4 times daily,
    especially at night, in the morning or after each bowel
    movement

  • DOSAGE & ADMINISTRATION

    Children under 12 years of age: consult a doctor

  • WARNINGS

    For rectal use only
    Ask a doctor or pharmacist before use if your are
    presently taking a prescription drug for high blood
    pressure or depression
    Ask a doctor before use if you have
    heart disease high blood pressure
    thyroid disease diabetes diffculty urination due to enlargement of
    the prostate gland
    When using this product
    do not exceed the recommended daily dosage unless
    directed by a doctor
    in case of bleeding or if condition worsens or does not
    improve within 7 days, consult a doctor promptly
    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

  • INACTIVE INGREDIENT

    methylparaben,propylparaben,shark liver oil,starch

  • STORAGE

    Store at room temperature or in a cool place
    but not over 80° F

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or
    contact a Poison Control Center right away

  • PRINCIPAL DISPLAY PANEL


    Lable of Box

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL 
    hemorrhoidal suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-045
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER85.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHARK LIVER OIL (UNII: 4B24275HEU)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-045-122 g in 1 BOX, UNIT-DOSE10/03/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34602/29/2012
    Labeler - Geritrex Corp. (112796248)
    Registrant - Geritrex Corp. (112796248)