Label: BLISS GVS CHILDREN- glycerin suppository

  • NDC Code(s): 72701-105-12, 72701-105-25
  • Packager: Bliss GVS Pharma Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 17, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each suppository)

    Glycerin USP, 1.2 grams

  • PURPOSE

    Purpose

    Laxative

  • INDICATIONS & USAGE

    Uses

    • for relief of occasional constipation
    • this product usually produces bowel movement in 1/4 to 1 hour
  • WARNINGS

    Warnings

    For rectal use only

    Do not usefor longer than one week unless directed by a doctor

    Ask a doctor before use if the child has

    • abdominal pain, nausea or vomiting
    • a sudden change in bowel habits lasting more than 2 weeks

    When using this productyour child may have rectal discomfort or a burning sensation

    Stop use and ask a doctor if the child has

    • rectal bleeding
    • no bowel movement after using this product

    These may indicate a serious condition.

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • children 2 to under 6 years of age: 1 suppository once daily
    • children under 2 years: ask a doctor
    • insert suppository well up into rectum and retain for 15 minutes
    • it need not melt to produce laxative action
  • STORAGE AND HANDLING

    Other information

    keep away from excessive heat.

  • INACTIVE INGREDIENT

    Inactive ingredientspurified water, sodium stearate

  • QUESTIONS

    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

    NDC 72701-105-12

    Children GLYCERIN SUPPOSITORIES

    LAXATIVE

    For ages 2 to 5 years

    For fast, gentle relief of occasional constipation

    12 Suppositories

    Glycerin Child Suppositories

  • INGREDIENTS AND APPEARANCE
    BLISS GVS   CHILDREN
    glycerin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72701-105
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1.2 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72701-105-122 in 1 CARTON01/20/2020
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:72701-105-255 in 1 CARTON01/20/2020
    25 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00701/20/2020
    Labeler - Bliss GVS Pharma Limited (675629890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bliss GVS Pharma Limited675630493manufacture(72701-105) , analysis(72701-105) , pack(72701-105) , label(72701-105)