Label: LEADER MINERAL OIL- mineral oil liquid

  • NDC Code(s): 70000-0448-1
  • Packager: Cardinal Health, 110 dba Leader
  • 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 March 17, 2022

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  • ACTIVE INGREDIENT

    Mineral Oil

  • PURPOSE

    Lubricant Laxative

  • INDICATIONS & USAGE

    For relief of occasional constpation or irregularity. Generally produces bowel movement in 6 to 8 hours.

  • WARNINGS

    Do not use if you have difficulty swallowing, in children under 12 years of age, if you are pregnant, for a period longer than 1 week, if you are bedridden or aged, if you are presently taking a stool softener laxative

  • ASK DOCTOR

    Ask a doctor before usage if you hav abdominal pain, nausea, or vomiting, noticed a sudden change in bowel habits that persists over a period of 2 weeks.

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. In case of eye contact wash gently with water for 15 minutes.

  • STOP USE

    and consult a doctor if there is a fialure to have a bowel movement after use.

  • DOSAGE & ADMINISTRATION

    Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime.


    Children 6 to 12 yes of age: 1 to 3 teaspoonfulls at bedtime.

    Children under 6 yrs of age: Consult a doctor before use

  • INACTIVE INGREDIENT

    dl-alpha-tocopherol as a preservative

  • OTHER SAFETY INFORMATION

    Keep tightly closed and protected from direct light

  • PRINCIPAL DISPLAY PANEL

    mineraloil

  • INGREDIENTS AND APPEARANCE
    LEADER MINERAL OIL 
    mineral oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0448
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL1000 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0448-1473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/18/2018
    Labeler - Cardinal Health, 110 dba Leader (063997360)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114analysis(70000-0448) , manufacture(70000-0448) , pack(70000-0448) , label(70000-0448)
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