Label: GLYCERIN ADULT- 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 14, 2011

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  • Active Ingredient (in each suppository)

    Glycerin 2 g.................Hyperosmotic Laxative

  • Use

    For relief of occasional constipation.

  • Warnings

    For rectal use only.

    May cause rectal discomfort or a burning sensation.

  • Ask a doctor before using any laxative if you have

    • abdominal pain, nausea or vomiting
    • a sudden change in bowel habits lasting more than 2 weeks
    • already used a laxative for more than 1 week 
  • Stop use and consult a doctor if you have

    • rectal bleeding
    • no bowel movement after using 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

    adults and children 6 years and over
    		1 suppository, or as directed by a doctor
    children 2 to under 6 years
    		use Pedia-Lax Glycerin Suppositories
    children under 2 years
    		ask a doctor

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

  • Other Information

    • This product generally produces a bowel movement in 1/4 to 1 hour.
    • Store container tightly closed.
    • Keep away from excessive heat.
    • MOUTH OF JAR SEALED FOR SAFETY. IF FOIL IMPRINTED WITH GREEN FLEET EMBLEM IS BROKEN OR MISSING, DO NOT USE.
  • Inactive Ingredients

    edetate disodium, purified water, sodium hydroxide, stearic acid

  • Questions?

    1-866-255-6960 or www.fleetlabs.com

  • PRINCIPAL DISPLAY PANEL

    Glycerin Suppositories laxative 

    12 Adult Suppositories

    NDC 54868-2923-0

    image of label



    Additional barcode label appied by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma     74146

  • INGREDIENTS AND APPEARANCE
    GLYCERIN  ADULT
    glycerin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2923(NDC:0132-0079)
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin2 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-2923-012 in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/09/2010
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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