Label: FLEET- mineral oil enema

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

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 January 14, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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
    • for complete Professional Use, Warnings and Precautions, consult the Reference Safety Information on our website
  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Fleet®

    Mineral Oil
    enema

    lubricant laxative

    1 bottle - 4.5 FL OZ (133 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:0132-0301
    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 NOT FINALpart33405/01/2002
    Labeler - C.B. Fleet Company, Inc. (003119054)