Label: MINERAL OIL liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 2, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient

    Mineral oil 99.9%

  • Purpose

    Lubricant laxative

  • Use

    for relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 8 hours.

  • Do not use

    • if you have difficulty swallowing
    • in children under 6 years of age
    • if you are pregnant
    • for a period longer than week
    • if you are bedridden or aged
  • 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
  • Ask a doctor or pharmacist before use if you are

    • presently taking a stool softener laxative
    • taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work
  • 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 breast feeding

    ask a health professional before use.

  • Keep out of reach of children.

    in case of overdose, get medical help or contact a Poison Control Center 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 - 1 to 3 Tablespoons (15 - 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

    children 6 to under 12 years of age - 1 to 3 teaspoons (5 - 15 mL) maximum 3 teaspoons (15 mL) in 24 hours

    children under 6 years of age - do not use, consult a doctor

  • Other information

    keep tightly closed. Protect from sunlight.

  • Inactive ingredients

    mixed tocopherols (added as a stabilizer)

  • Adverse reaction

    Distributed by C.D.M.A., Inc.

    43157 W 9 Mile Rd,

    Novi, MI 48375

    www.qualitychoice.com

    Questions: 800-935-2362

  • Principal display panel

    SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

    QC

    QUALITY CHOICE

    Mineral OIl

    U.S.P.

    Lubricant Laxative

    For Relief of Occasional Constipation

    Odorless - Tasteless - Colorless

    16 FL OZ (473 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    MINERAL OIL 
    mineral oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-171
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL999 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83324-171-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00707/02/2024
    Labeler - C.D.M.A. (011920774)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(83324-171)