Label: HEMORRHOIDAL- cocoa butter, phenylephrine hcl suppository

  • NDC Code(s): 68016-322-12, 68016-322-24
  • Packager: Pharmacy Value Alliance LLC
  • Category: HUMAN OTC DRUG LABEL

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

  • Questions or comments?

    1-800-492-5988

  • PRINCIPAL DISPLAY PANEL

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

    Premier Value Hemorrhoidal Suppositories 12ct

    Distributed by Pharmacy Value Alliance LLC

    407 East Lancaster Avenue

    Wayne, PA 19087

    785PVHemSupp.jpg

    Premier Value Hemorrhoidal Suppositories

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL 
    cocoa butter, phenylephrine hcl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-322
    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:68016-322-122 in 1 CARTON08/16/2019
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:68016-322-244 in 1 CARTON08/16/2019
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01508/16/2019
    Labeler - Pharmacy Value Alliance LLC (101668460)
    Registrant - DSC Laboratories Inc. (097807374)
    Establishment
    NameAddressID/FEIBusiness Operations
    DSC Laboratories Inc.097807374manufacture(68016-322)
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