Label: HEMORRODIL- phenylephrine hydrochloride and cocoa butter 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 March 11, 2014

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Phenylephrine Hydrochloride 0.25%Vasoconstrictor
    Cocoa Butter 88.44%Protectant
  • Uses

    • Temporarily shrinks hemorrhoidal tissues
    • Provides temporary relief from the itching, burning and discomfort associated with hemorrhoids
    • Aids in protecting irritated anorectal areas
  • Warning

    For rectal use only

    Ask a doctor or pharmacist before use if you 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
    • difficulty in urination due to enlargement of the prostate gland

    When using this product

    • do not exceed recommended daily dose 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.

  • Directions

    Adults

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

    Children under 12 years of age, consult a doctor

  • Other information

    Store at temperature 59° – 86°F

  • Inactive ingredients

    methylparaben, propylparaben, starch

  • PRINCIPAL DISPLAY PANEL - 12 Suppository Blister Pack Carton

    HEMORRODIL®

    Soothing &
    Refreshing

    12 SUPPOSITORIES

    Principal Display Panel - 12 Suppository Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    HEMORRODIL 
    phenylephrine hydrochloride and cocoa butter suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61357-135
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER1768.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61357-135-011 in 1 CARTON
    112 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34603/01/1964
    Labeler - ZURICH MEDICAL LABS, LLC (071904097)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZURICH MEDICAL LABS, LLC071904097MANUFACTURE(61357-135)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!