Label: FLEET- glycerin suppository

  • NDC Code(s): 0132-0075-00, 0132-0075-12, 0132-0075-24, 0132-0075-50
  • Packager: C.B. Fleet Company, Inc.
  • 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 April 23, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    (in each suppository)

    Glycerin 2 g

  • Purpose

    Hyperosmotic laxative

  • Uses

    • for relief of occasional constipation
    • this product usually produces bowel movement in ¼ to 1 hour
  • Warnings

    For rectal use only.

    Do not use

    laxative products 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

    When using this product

    rectal discomfort or burning sensation may occur.

    Stop using this product and consult a doctor if you have

    • 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 (1-800-222-1222) right away.

  • Directions

    Single Daily Dosage (per 24 hours)

    adults and children 6 years and over1 suppository or as directed by a doctor
    children 2 to under 6 yearsuse Fleet® Pedia-Lax™ Suppositories
    children under 2 yearsconsult a doctor

    Insert suppository well up into rectum, to produce laxative action. Suppository is designed to dissolve only partially, which may not be noticeable.

  • Other information

    • Store container tightly closed

    • Keep away from excessive heat

    • Mouth of jar sealed for safety. If foil imprinted with green Fleet® emblem is missing or torn, do not use.

  • Inactive ingredients

    aloe vera leaf, edetate disodium, purified water, sodium hydroxide, stearic acid

  • Questions?

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

  • Principal Display Panel

    Fleet®
    Glycerin
    Laxative suppositories

    12 adult suppositories

    Fleet® 
Glycerin 
Laxative suppositories

12 adult suppositories

  • Principal Display Panel

    Fleet®
    Glycerin
    Laxative suppositories

    24 adult suppositories

    Fleet® 
Glycerin 
Laxative suppositories

24 adult suppositories

  • Principal Display Panel

    Fleet®
    Glycerin
    Laxative suppositories

    50 adult suppositories

    Fleet® 
Glycerin 
Laxative suppositories

50 adult suppositories

  • Principal Display Panel

    Fleet®
    Glycerin
    Laxative suppositories

    100 adult suppositories

    Fleet® 
Glycerin 
Laxative suppositories

100 adult suppositories

  • INGREDIENTS AND APPEARANCE
    FLEET 
    glycerin suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0075
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0075-00100 in 1 JAR; Type 0: Not a Combination Product11/01/1984
    2NDC:0132-0075-1212 in 1 JAR; Type 0: Not a Combination Product11/01/1984
    3NDC:0132-0075-2424 in 1 JAR; Type 0: Not a Combination Product11/01/1984
    4NDC:0132-0075-5050 in 1 JAR; Type 0: Not a Combination Product11/01/1984
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33411/01/1984
    Labeler - C.B. Fleet Company, Inc. (003119054)