Label: LEADER READY TO USE MINERAL OIL LAXATIVE- 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 118 mL delivered dose)

    Mineral oil 100%

  • Purpose

    Lubricant laxative

  • Uses

    • for relief of occasional constipation
    • for relief of fecal impaction
    • for removal of residue after barium administration
  • Warnings

    For rectal use only

    Ask a doctor before use

    • if you have abdominal pain, nausea, or vomiting
    • if you have a sudden change in bowel habits that persists over a period of 2 weeks
    • if you have already used a laxative for more than 1 week
    • if constipation continues after one week of use, contact your doctor

    Stop use and ask a doctor if

    • you have rectal bleeding or no bowel movement within 15 minutes of using this product
    • you need to use a laxative for more than one week

    These symptoms may indicate a serious condition.

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children to prevent accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    Single daily dose (per 24 hours).

    adults & children 12 years and over1 bottle once daily
    children 2 to under 12 years1/2 bottle once daily discard unused portion
    children under 2 yearsDO NOT USE
  • Other information

    • store at 15°-30°C (59°-86°F)
    • this product generally produces a bowel movement in 2 to 15 minutes
  • Inactive ingredients

    none

  • Questions or comments?

    1-866-323-0107

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017

  • PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

    LEADER™

    NDC 70000-0109-1

    Ready-To-Use
    Enema
    Mineral Oil
    Lubricant Laxative

    Sodium Free

    For Relief Of:

    Occasional
    Constipation

    Comfortable,
    Lubricated Tip

    Works in
    Minutes

    Not Made
    With Natural
    Rubber
    Latex

    COMPARE TO
    FLEET® MINERAL
    OIL ENEMA
    active ingredient*

    1 BOTTLE

    100% Money
    Back Guarantee

    4 .5 FL OZ (133 mL)

    PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    LEADER READY TO USE MINERAL OIL   LAXATIVE
    mineral oil enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0109
    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:70000-0109-11 in 1 CARTON02/19/2013
    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 DrugM00702/19/2013
    Labeler - Cardinal Health (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(70000-0109)
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