Label: 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 December 13, 2022

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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 not finalpart33409/23/2016
    Labeler - H E B (007924756)
    Registrant - DSC Laboratories, Inc. (097807374)
    Establishment
    NameAddressID/FEIBusiness Operations
    DSC Laboratories, Inc.097807374manufacture(37808-399)
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