Label: BLISS GVS CHILDREN- glycerin suppository

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 18, 2020

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  • 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 use for 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 product your 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 ingredients purified 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 not finalpart33401/20/2020
    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)
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