Label: FLEET- mineral oil liquid

  • NDC Code(s): 0132-0400-48
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL/teaspoonful)

    Mineral Oil 2.5 mL.......................................

  • Purpose

    Lubricant Laxative

  • Uses

    ▪ relieves occasional constipation

    ▪ generally produces bowel movement in 6 to 8 hours

  • Warnings

    Do not use

    ▪ for children under 6 years of age, pregnant women, bedridden patients or persons with difficulty swallowing

    Ask a doctor before using this product if you have

    ▪ abdominal pain, nausea or vomiting

    ▪ a sudden change in bowel habits that persists over a period of 2 weeks

    Ask a doctor or pharmacist before use if you are

    presently taking a stool softener laxative.

    When using this product

    do not take with meals.

    Stop use and ask a doctor if

    ▪ you notice rectal bleeding or fail to have a bowel movement after use of a laxative. This may indicate a serious condition. Discontinue use and consult a doctor.

    ▪ you need to use the product more than one week

    If breast-feeding,

    ask a health professional before use. 

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    ▪ do not take with meals

    ▪ shake well before using

    ▪ adults and children 12 years of age and over: 3 to 9 teaspoons  (15 - 45 mL), maximum 9 teaspoons (45 mL) in 24 hours

    ▪ children 6 to under 12 years of age: 1 to 3 teaspoons (5 – 15 mL), maximum 3 teaspoons (15 mL) in 24 hours or as directed by a doctor

    ▪ children under 6 years of age: consult a doctor

  • Inactive ingredients

    acacia, benzoic acid, carrageenan (irish moss), ethyl vanillin, glycerin, mapliene triple oil, purified water, titanium dioxide, vanillin

  • Other information

    Store at room temperature 15°-25°C (59°-77°F)

  • Questions?

    Call toll-free 1-855-727-4277

  • Principal Display Panel

    Fleet ® 
    Laxative
    Mineral Oil
    Oral Liquid
    Lubricant Laxative

    16 FL OZ (480 mL)

    Fleet ® Laxative Mineral Oil Oral Liquid Lubricant Laxative 16 FL OZ (480 mL)

  • INGREDIENTS AND APPEARANCE
    FLEET 
    mineral oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0400
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL2.5 g  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    VANILLIN (UNII: CHI530446X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0400-48480 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00704/01/2024
    Labeler - C.B. Fleet Company, Inc. (003119054)
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