Label: FLEET- glycerin liquid

  • NDC Code(s): 0132-0185-01, 0132-0185-82
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 March 22, 2021

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  • SPL UNCLASSIFIED SECTION

    FLEET- glycerin liquid

    C.B. Fleet Company, Inc.

    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.

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    Drug Facts

  • Active Ingredient (in each 5.4 mL average delivered dose)

    Glycerin 5.4 g, Hyperosmotic Laxative

  • Purpose

  • Use

    For relief of occasional constipation

    This product usually produces a bowel movement within 15 minutes to 1 hour.

  • Warnings

    For rectal use only.

    May cause rectal discomfort or a burning sensation.

    Do not use when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

  • Ask a doctor before using any laxative if you

    • have a sudden change in bowel habits lasting more than 2 weeks 
    • already used a laxative for more than 1 week
  • Stop using this product and consult a doctor if you have

    • rectal bleeding
    • no bowel movement after use of a laxative 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 (per 24 hours

    adults and children 6 years and over       1 suppository, or as directed by a doctor

    children 2 to under 6 years       use Fleet Pedia-Lax Liquid Glycerin Suppositories children under 2 years       ask a doctor

    CAUTION: REMOVE ORANGE PROTECTIVE SHIELD BEFORE INSERTING.

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

  • Other Information

    • Carton sealed for safety. If seal with Fleet emblem on top or bottom flap is torn, damaged or missing, do not use.
  • Inactive Ingredients

    edetate disodium, purified water

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Fleet Liquid Glycerin Suppositories 4 Adult Suppositories

    PRINCIPAL DISPLAY PANEL Fleet Liquid Glycerin Suppositories 4 Adult Suppositories

  • INGREDIENTS AND APPEARANCE
    FLEET 
    glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0185
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN5.4 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0185-011 in 1 PACKAGE; Type 0: Not a Combination Product06/03/2002
    2NDC:0132-0185-824 in 1 CARTON; Type 0: Not a Combination Product06/03/2002
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33406/03/2002
    Labeler - C.B. Fleet Company, Inc. (003119054)
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