Label: ENEMA MINERAL OIL- mineral oil enema

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 31, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 120 ml delivered dose)

    Mineral oil 100%

  • Purpose

    Lubricant laxative

  • Use

    • for relief of occasional constipation
    • this product generally produces bowel movement in 2 to 15 minutes
  • Warnings

    For rectal use only.

    Caution

    To be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician.

    Do not use

    • on children under 13 years of age
    • on pregnant women
    • on persons with difficulty swallowing
    • on bedridden patients
    • if you are presently taking a stool softener laxative
    • or take with meals

    Ask a doctor before use if you

    • have already used a laxative for more than 3 days
    • have abdominal pain, nausea, or vomiting
    • have a sudden change in bowel habits that persist over a period of 2 weeks

    Stop use and ask a doctor if

    • you have rectal bleeding
    • you have no bowel movement within 30 minutes of enema use

    As with any drug, if you are nursing a baby, seek the advice of a health professional before using this product.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions (or as directed by a doctor)

    Rectal enema dosage is 120 ml in a single daily dosage (per 24 hours).

    Adults & children 13 years old and older1 bottle
    Children under 13 years oldDO NOT USE
  • Other information

    • Store at 15 to 30°C (59 to 86°F).
    • Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.
  • Inactive ingredient

    None

  • Questions or comments?

    1-866-323-0107 or www.natureplex.com

  • PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

    *Compare To Fleet® Mineral Oil Enema

    Natureplex™

    READY TO USE

    Enema

    Mineral
    Oil

    Sodium
    Free

    For
    Relief Of
    Occasional
    Constipation

    Not Made
    With
    Natural
    Rubber
    Latex

    Soft,
    Easy To
    Use
    Bottle

    NDC 67234-019-01

    1
    Bottle
    4.5 Fl Oz
    (133 mL)

    PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ENEMA MINERAL OIL 
    mineral oil enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-019
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP) Mineral Oil118 g  in 118 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67234-019-011 in 1 CARTON01/05/2013
    1133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00701/05/2013
    Labeler - Natureplex LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(67234-019)
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