Label: FLEET- mineral oil enema

  • NDC Code(s): 0132-0301-40
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 26, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 118 mL delivered dose)

    Mineral oil 100%

  • Purpose

    Lubricant laxative

  • Uses

    • for relief of fecal impaction
    • for relief of occasional constipation
    • for removal of residue after barium administration

    This product usually produces a bowel movement in 2 to 15 minutes.

  • Warnings

    For rectal use only.

    Do not use

    when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

    Ask a doctor before using this product if you

    • have a sudden change in bowel habits lasting more than 2 weeks
    • already used a laxative for more than 1 week

    Stop use and ask a doctor if you have

    • rectal bleeding
    • no bowel movement within 15 minutes of using this product

    These symptoms may indicate a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use. 

    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
    12 years and over    		1 bottle per day
    children
    2 to under 12 years    		one-half bottle
    children
    under 2 years    		DO NOT USE
  • Other information

    • sodium-free
  • Inactive Ingredients

    none

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Fleet®
    Laxative

    Mineral Oil enema
    lubricant laxative
    1 bottle - 4.5 FL OZ (133 mL)

    Fleet® Laxative 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:0132-0301
    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:0132-0301-40133 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 DrugM00705/01/2002
    Labeler - C.B. Fleet Company, Inc. (003119054)
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