Label: MINERAL OIL- mineral oil enema

  • 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

    Active Ingredient                            Purpose

    Mineral Oil, 100%                    Lubricant Laxative            

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  • Uses:

    • Gentle relief of occasional constipation
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  • Warnings:

    For rectal use only



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  • As 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

    • If pregnant or breast feeding, ask a health professional before use.
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  • Stop use and ask a doctor if:

    • If you have rectal bleeding or failure to have a bowel movement after use of a laxative because this amy indicate a serious condition
    • you need to use a laxative for more than one week
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  • Keep out of reach of children

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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  • Other information:

    • Store at room temperature 20 Deg C - 25 Deg C (68 Deg F - 77 Deg F)
    • This product produces bowel movement in 2 to 15 minutes
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  • Directions

    Single daily dose

    Adults and children 12 years and older - 1 bottle

    Children 2 to under 12 years - 1/2 bottle

    Children under 2 years - Do not use. Consult a physician.


    How to use this enema:

    REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING.

    Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with the other hand and pull gently to remove.

    See image on box

    Positioning

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

    See image on box

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

    See image on box

    Administering Enema

    • With steady pressure, gently insert enema with tip pointing toward navel.
    • Squeeze bottle until recommended dose is expelled (it is not necessary to

      empty unit completely. Bottle contains more liquid than needed for effective

      use. A small amount of liquid will remain in bottle after squeezing).

    • Remove tip from rectum.

    • Stop using if tip is hard to insert. Forcing the tip into the rectum can

      cause injury (especially if you have hemorrhoids). If enema tip causes

      rectal bleeding or pain, get immediatemedical care.

    • Maintain position until urge to evacuate is strong (usually 1 to 5 minutes).

    • If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor

      promptly if no liquid comes out of the rectum after 30 minutes because

      dehydration could occur.

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  • Principal Display Panel

    Mineral oil enema.jpg

    Mineral oil enema

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  • INGREDIENTS AND APPEARANCE
    MINERAL OIL 
    mineral oil enema
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67777-401
    Route of Administration RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MINERAL OIL (MINERAL OIL) MINERAL OIL 118 mg  in 118 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67777-401-01 48 in 1 CASE
    1 1 in 1 BOX
    1 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 08/29/2012
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    Name Address ID/FEI Business Operations
    Galentic Pharma (India) Pvt. Ltd. 864201135 manufacture(67777-401)
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