Label: FLEET- mineral oil enema

  • NDC Code(s): 0132-0301-40
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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

  • Active Ingredient

    (in each 118-mL delivered dose)

    Mineral Oil 100% ......Lubricant Laxative

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  • Uses

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

    For rectal use only.

    If pregnant or breast-feeding ask a health professional before use.

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  • Directions

    Single daily dose

    adults and children 12 years and over
    1 bottle


    children 2 to under 12 years
    one-half bottle


    children under 2 years
    DO NOT USE
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  • Other Information

    Other Information

    • sodium free
    • this product generally produces a bowel movement in 2-15 minutes
    • carton sealed for safety. If seal with Fleet emblem on top or bottom flap is missing, do not use
    • consult Physicians' Desk Reference for complete professional labeling
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  • Questions?

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

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  • Ask a doctor before using any laxative if you have

    • abdominal pain, nausea or vomiting 
    • a sudden change in bowel habits lasting more than 2 weeks
    • already used a laxative for more than 1 week
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  • Stop use and ask a doctor if you have

    • rectal bleeding
    • no bowel movement after use

    These symptoms may indicate a serious condition.

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  • Keep out of reach of children


    If swallowed, get medical help or contact a Poison Control Center right away.

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  • INGREDIENTS AND APPEARANCE
    FLEET 
    mineral oil enema
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0132-0301
    Route of Administration RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Mineral Oil (Mineral Oil) Mineral Oil 118 mL  in 118 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0132-0301-40 133 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 05/01/2002
    Labeler - C.B. Fleet Company, Inc. (003119054)
    Establishment
    Name Address ID/FEI Business Operations
    C.B. Fleet Company, Inc. 003119054 manufacture(0132-0301)
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