Label: MINERAL OIL oil

  • NDC Code(s): 36800-334-16
  • Packager: TOP CARE (Topco Associates LLC)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 24, 2025

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  • Active Ingredient

    Mineral Oil 100%

  • Purpose

    Lubricant laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 6 to 8 hours
  • Warnings

    Do not use

    • in children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowing
    • if you are presently taking a stool softener laxative
    • for longer than 1 week

    Ask a doctor before use if you have

    • abdominal pain, nausea or vomiting
    • noticed a sudden change in bowel habits that persists over a period of 2 weeks

    When using this product

    • do not take with meals
    • take only at bedtime

    Stop use and ask a doctor if you have

    rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

    If pregnant or breast feeding,

    ask a health professional before 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

    In case of overdose, get medical help or contact a Poison Control center (1-800-222-1222) right away.

  • Directions

    • do not take with meals
    • take only at bedtime
    • may be taken as a single daily dose or in divided doses
    • adults and children 12 years of age and over: oral dosage is a minimal single dose of 15 mL to a maximum daily dose of 45 mL
    • children 6 to under 12 years of age: oral dosage is a minimum single dose of 5 mL to a maximum daily dose of 15 mL
    • children under 6 years, consult a doctor 
  • Other Information

    • keep tightly closed
    • protect from direct light
  • Inactive Ingredient

    Vitamin E as stabilizer

  • Principal Display Panel

    Mineral Oil

    LUBRICANT LAXATIVE

    • For Relief of Occasional Constipation
    • Odorless
    • Tasteless
    • Colorless

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ITASCA, IL 60143

    Questions or comments? Call toll free 1-888-423-0139

  • Package Label

    Mineral Oil 100%

    TOPCARE HEALTH Mineral Oil

     

  • INGREDIENTS AND APPEARANCE
    MINERAL OIL 
    mineral oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-334
    Route of AdministrationORAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL100 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-334-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00711/30/2016
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
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