Label: MINERAL OIL LUBRICANT LAXATIVE- mineral oil enema 

  • Label RSS
  • 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 03/14

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

  • Active ingredient

    (in each 118 mL delivered dose)

    Mineral oil 100%

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  • Purpose

    Lubricant laxative

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  • Uses

    for relief of occasional constipation
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  • Warnings

    For rectal use only

    Ask a doctor before use if you have

    abdominal pain, nausea or vomiting
    notice a sudden change in bowel habits that persists over a period of 2 weeks

    Stop use and ask a doctor if

    you have rectal bleeding or failure to have a bowel movement after use of a laxative because this may indicate a serious condition
    you need to use a laxative for more than one week

    If pregnant or breastfeeding, 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. (1-800-222-1222)

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  • Directions

    Single daily dose

    adults & children

    12 years and over

    1 bottle once daily

    children 2 to under

    12 years

    1/2 bottle once daily

    children under

    2 years

    do not use

    How to use this enema:

    REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING; HOLD BOTTLE UPRIGHT, GRASPING BOTTLE CAP WITH FINGERS. GRASP PROTECTIVE SHIELD WITH OTHER HAND AND PULL GENTLY TO REMOVE.

    Remove protective shield illustration

    Positioning:

    Left-side position: Lie on left side with knee bent and arms at rest.

    Left Side position illustration

    Knee-chest position:

    Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.

    Knee-chest position illustration

    Administering enema:

    With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus.
    Do not force the enema tip into rectum as this can cause injury.
    Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed.
    Remove enema tip from rectum.
    Retain enema in accordance with doctor's instructions.
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  • Other Information

    store at room temperature 20-25 deg C (68-77 deg F)
    this product generally produces bowel movement in 2-15 minutes
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  • Inactive ingredient

    none

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  • Questions or comments?

    1-800-633-5463

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  • Side and Principal Display Panel - Box

    CVS Mineral Oil Enema box principal display panel

    NDC 59779-996-11

    CVS Pharmacy

     Compare to the active ingredient in Fleet Mineral Oil Enema

    MINERAL OIL

    ENEMA

    LUBRICANT LAXATIVE

     
    Pre Mixed
     
    For relief of occasional constipation
     
    Lubricated tip

    4.5 FL OZ (133 ml)

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  • Side and Back Panel - Box
  • INGREDIENTS AND APPEARANCE
    MINERAL OIL LUBRICANT LAXATIVE 
    mineral oil enema
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-996
    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:59779-996-11 1 in 1 BOX
    1 133 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 07/16/2012
    Labeler - CVS Pharmacy (062312574)
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