Label: FLEET- mineral oil enema

  • NDC Code(s): 0132-0556-40
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated May 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Fleet Mineral Oil

    Drug Facts

  • Active ingredient

    Mineral oil (Heavy) 130 mL

  • Purpose

    Lubricant laxative

  • Uses

    • relieves occasional constipation
    • softens the stool
  • Warnings

    Do not use

    with any other laxative.

    Ask a doctor or pharmacist before use if you have 

    • abdominal pain
    • nausea or vomiting
    • fever
    • noticed a sudden change in bowel habits lasting for longer than 2 weeks
    • are pregnant or breastfeeding

    When using this product

    • do not take it within 2 hours of other medicines
    • it may take 2 to 15 minutes to have a bowel movement
    • overuse or extended use may cause dependence for bowel function

    Stop use and ask a doctor if

    • rectal bleeding occurs
    • symptoms last for more than 7 days.

    This may be a sign of serious condition.

  • Inactive

    • None

    Other warnings 

    • overuse or extended use may cause dependence for bowel function
    • do not give to infants or children under 12 years, or to bedridden or aged patients, unless directed by a doctor
  • Keep out of reach of children.

    In case of overdose, call a poison control centre or get medical help right away.

  • Directions

    • Adults and children 12 years and older; take 120 mL as a single dose
    • Do not take more than 120 mL in 24 hours
  • Other information

    store at room temperature

  • Questions?

    Call 1-866-255-6960 

  • PRINCIPAL DISPLAY PANEL

    Fleet®

    Mineral Oil
    Enema

    130 mL

    PRINCIPAL DISPLAY PANEL Fleet® Mineral Oil Enema 130 mL

  • INGREDIENTS AND APPEARANCE
    FLEET 
    mineral oil enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0556
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL100 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0556-40130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/01/2002
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only05/01/2002
    Labeler - C.B. Fleet Company, Inc. (003119054)
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