Label: GLYCERIN suppository

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 8, 2023

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  • Active ingredient (in each suppository)

    Glycerin 1g

  • Purpose

    Laxative

  • Uses

    • for relief of occassional constipation
    • this product generally produces bowel movement in 1/4 to 1 hour
  • Warnings

    For rectal use only

    May cause rectal discomfort or a burning sensation.

    Ask a doctor before using any laxative if child has

    • abdominal pain, nausea or vomiting
    • a sudden change in bowel habits lasting more than 2 weeks
    • already used a laxative formore than 1 week

    Stop use and consult a doctor if child has

    • rectal bleeding
    • no bowel movement within 1 hour using this product

    These symptoms may indicate a serious condition.

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

  • Directions - single daily dose

    children 2 to under 6 years - 1 suppository, or as directed by a doctor

    chidren under 2 - ask a doctor

    Insert suppository well up into rectum. Suppository need not melt completely to produce laxative action.

  • Other information

    • Store container tightly closed.
    • Keep away from excessive heat.
  • Inactive ingredients

    purified water, sodium hydroxide, stearic acid

  • Questions or comments?

    1-800-492-5988

  • Label

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

    Pediatric Glycerin Suppositories, 25 count

    Distributed by H-E-B, San Antonio, TX 78204 1002

    HEBPed25.jpg

    HEB Pediatric 25ct

  • INGREDIENTS AND APPEARANCE
    GLYCERIN 
    glycerin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-399
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-399-2525 in 1 JAR; Type 0: Not a Combination Product09/23/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00709/23/2016
    Labeler - H E B (007924756)
    Registrant - DSC Laboratories, Inc. (097807374)
    Establishment
    NameAddressID/FEIBusiness Operations
    DSC Laboratories, Inc.097807374manufacture(37808-399)