Label: MEDLINE ENEMA- mineral oil enema

  • NDC Code(s): 53329-008-11
  • Packager: Medline Industries, 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 01/10

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

  • Active ingredient (in each 118 mL delivered dose)

    Mineral Oil USP

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  • Purpose

    Lubricant Laxative

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  • Uses

    • for relief of fecal impaction or occasional constipation, without straining or irritating the mucosa of the bowel, by lubricating and softening the stool
    • generally produces bowel movement in 2 to 15 minutes.

     

    Professional use:

    • for cleansing the bowel and removal of residue after barium enema administration.
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  • Warnings

    Dosage warning: Using more than one enema in 24 hours can be harmful.

    CAUTION: FOR RECTAL USE ONLY.

    Ask a doctor before using any laxative if you:

    • have nausea, vomiting, or abdominal pain
    • have sudden change in bowel habits lasting more than 2 weeks
    • have already used a laxative for more than 1 week

    Ask a doctor or pharmacist before use if you

    are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

    When using this product, do not use more than directed.

    Serious side effects may occur from excess dosage.

    Stop using this product and consult a doctor if you:

    • have rectal bleeding
    • have no bowel movement after the enema is given

    These symptoms may indicate a serious condition.

    If pregnant or breastfeeding,

    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.

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  • Directions

    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.

    Illustration #1

    Do not use more unless directed by a doctor. See Warnings.

    adults & children 12 years and older one bottle once daily
    children 2 to under 12 years ½ bottle once daily
    children under 2 years do not use

    Positioning:

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

    Illustration #2

    Knee-chest position: kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.

    Illustration #3

    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 the 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

    Follow with a cleansing enema: To remove stools or other residue now softened or lubricated, it is suggested that you use a regular enema to cleanse the bowel.

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  • Other information

    • bottle, cap and shield are latex-free.
    • Consult Physicians’ Desk Reference® for complete professional labeling.
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  • Principal Display Panel

    Complete

    Enema

    Ready-to-Use

    Mineral Oil

    Comfortable, lubricated tip

    Lubricant Laxative

    Latex free product

    Contents: 1 Each

    Enema Carton

    Enema Carton

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  • INGREDIENTS AND APPEARANCE
    MEDLINE ENEMA 
    mineral oil enema
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53329-008
    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:53329-008-11 1 in 1 CARTON
    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 01/06/2010
    Labeler - Medline Industries, Inc. (025460908)
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