Label: HEMORRHOIDAL- cocoa butter, phenylephrine hcl suppository

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 8, 2023

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  • Active Ingredients (per suppository)

    Cocoa butter 88.44%

    Phenylephrine hydrochloride 0.25%

  • Purpose

    Protectant

    Vasoconstrictor

  • Uses

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

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

    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

  • Directions

    Adults

    • 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
    • children under 12 years of age: consult a doctor
  • Other information

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

  • Inactive ingredients

    corn starch, methylparaben, propylparaben

  • PRINCIPAL DISPLAY PANEL

    The product package shown below represents a sample of that currently in use. Additional packaging may also be available.

    Hemorrhoidal Suppositories 48ct

    Distributed by CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    785HemSupp.jpg

    Hemorrhoidal Suppositories

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL 
    cocoa butter, phenylephrine hcl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-785
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER2.39 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE6.75 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-785-488 in 1 CARTON03/15/2019
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01503/15/2019
    Labeler - CVS Pharmacy (062312574)
    Registrant - DSC Laboratories Inc. (097807374)
    Establishment
    NameAddressID/FEIBusiness Operations
    DSC Laboratories Inc.097807374manufacture(69842-785)
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