Label: GLYCERIN- glycerin suppository

  • NDC Code(s): 68016-161-00
  • Packager: Chain Drug Consortium LLC
  • 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 November 3, 2021

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

  • Active ingredient (in each suppository)

    Glycerin 1 g

  • Purpose

    Hyperosmotic laxative

  • Uses

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

    For rectal use only

    May cause rectal discomfort of burning sensation

    Ask a Doctor before using laxative if child has

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

    Stop use and consult a doctor if child has

    • rectal bleeding
    • no bowel movement within 1 hour of 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 dosage
    children 2 to under 6 years1 suppository or as directed by a doctor
    children under 2 yearsask a doctor

    Insert suppository well up intorectum.

    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

  • Pediatric Glycerin Suppositories, 25 count

    PremVal722.jpg

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

    PediatricGlycerin Suppositories, 25 count

    Distributed by Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue

    Wayne, PA 19087

    Premier Value Pediatric

  • INGREDIENTS AND APPEARANCE
    GLYCERIN  
    glycerin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-161
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-161-0025 in 1 JAR; Type 0: Not a Combination Product03/21/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/21/2012
    Labeler - Chain Drug Consortium LLC (101668460)
    Registrant - DSC Laboratories, Inc. (097807374)
    Establishment
    NameAddressID/FEIBusiness Operations
    DSC Laboratories, Inc.097807374manufacture(68016-161)