Label: BLISS GVS HEMORRHOIDAL- hard fat, phenylephrine hcl suppository

  • NDC Code(s): 72701-110-12, 72701-110-24
  • Packager: Bliss GVS Pharma Limited
  • 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 6, 2023

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  • Drug Facts

  • Active ingredients

    (in each suppository)

    Hard Fat 99.75%

    Phenylephrine HCl 0.25%

  • Purposes

    Protectant

    Vasoconstrictor

  • Uses

    • temporarily shrinks hemorrhoidal tissue
    • temporarily relieves the itching, burning and discomfort associated with hemorrhoids
  • Warnings

    For rectal use only

    Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • high blood pressure
    • diabetes
    • trouble urinating due to an enlarged prostate gland

    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 use more than directed

    Stop use and ask a doctor if

    • bleeding occurs
    • condition worsens or does not improve within 7 days

    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

    • when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.
    • gently dry by patting or blotting with a tissue or a soft cloth before insertion of suppository.
    • detach one suppository from the strip
    • separate the two tabs of the white plastic wrap
    • with thumb and forefinger of each hand, grasp the tabs and peel downward, unwrapping the suppository
    • insert one suppository into the rectum

    adults and children 12 years and over: insert one suppository rectally up to 4 times daily

    children under 12 years: ask a doctor

  • STORAGE AND HANDLING

    Other information

    store below 30°C (86°F) to avoid melting.

  • Inactive ingredients

    none

  • Questions or Comments?

    Call 1-888-830-6075

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF SEALED WRAPPER AROUND SUPPOSITORIES IS BROKEN OR MISSING

    Manufactured and Marketed by:

    BLISS GVS PHARMA LTD.

    102, Hyde Park, Saki Vihar Road, Andheri (E),

    Mumbai-400 072, INDIA

    Email: info@blissgvs.com • www.blissgvs.com

  • PRINCIPAL DISPLAY PANEL

    HEMORRHOIDAL SUPPOSITORIES

    NDC 72701-110-12

    RELIEVES HEMORRHOIDAL PAIN AND BURNING

    Bliss GVS

    12 Suppositories

    Hemorrhoidal Supp Final

  • INGREDIENTS AND APPEARANCE
    BLISS GVS HEMORRHOIDAL 
    hard fat, phenylephrine hcl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72701-110
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HARD FAT (UNII: 8334LX7S21) (HARD FAT - UNII:8334LX7S21) HARD FAT2493.75 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE6.25 mg
    Product Characteristics
    Color    Score    
    ShapeBULLETSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72701-110-122 in 1 CARTON05/13/2019
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:72701-110-244 in 1 CARTON05/13/2019
    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 finalM01505/13/2019
    Labeler - Bliss GVS Pharma Limited (675629890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bliss GVS Pharma Limited675630493manufacture(72701-110)
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