Label: MEIJER- mineral oil enema

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 July 2, 2015

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

  • Active ingredient

    (in each 118 mL delivered dose)

    Mineral oil 100%

  • Purpose

    Lubricant laxative

  • Uses

    for relief of occasional constipation
  • 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)

  • 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

    Discard unused portion

    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.

    Hand Positioning

     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.

     

    Positioning:

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

    Left Side Position

    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
  • Other Information

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

    none

  • Questions or comments?

    1-800-633-5463

  • Principal Display Panel

    NDC 41250-112-11

    Compare to Fleet® Mineral Oil Enema active ingredient*

    Meijer

    Ready-To-Use

    Enema Mineral Oil

    Sodium Free

    Lubricant Laxative

    For Relief of

    Occasional Constipation

    Latex Free

    Protective Shield prevents contamination

    Safety Seal for added protection

    Comfortable, lubricated tip for insertion

    One-way safety valve controls flow and prevents reflux

    Easy, soft squeeze bottle

    4.5 FL OZ (133ml)

    Principal Display Panel with Drug Facts
  • Back & Side Panel - Box

    Side Panel and Back Panel Packaging
  • INGREDIENTS AND APPEARANCE
    MEIJER 
    mineral oil enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-112
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL113.115 g  in 118 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-112-111 in 1 BOX
    1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/10/2013
    Labeler - Meijer Distribution Inc (006959555)