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: 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 15, 2021

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

  • 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 is 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.

    Other warning

    • 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

    Fleet®
Mineral Oil 
enema
lubricant laxative
1 bottle - 4.5 FL OZ (133 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
    OTC monograph not finalpart33405/01/2002
    Labeler - C.B. Fleet Company, Inc. (003119054)