Label: MINERAL OIL liquid

  • NDC Code(s): 51316-831-43, 51316-831-45
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 16, 2024

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  • 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.

  • Warnings

    for thsi product

  • Do not use

    • if you have difficulty swallowing
    • in children under 6 years of age
    • if you are pregnant
    • for a period longer than 1 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 to 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

    children 6 to under 12 years of age 1 to 3 teaspoons (5 to 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: CVS Pharmacy, Inc.

    One CVS Drive, Woodsocket, RI 02895

    ©2024 V-16453

  • PRINCIPAL DISPLAY PANEL

    CVS Health ®

    Mineral Oil USP

    LUBRICANT LAXATIVE

    • Odorless
    • Tasteless
    • Colorless

    16 FL OZ (1 PT) 473 mL

    mm01

  • INGREDIENTS AND APPEARANCE
    MINERAL OIL 
    mineral oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-831
    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:51316-831-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/16/2024
    2NDC:51316-831-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/16/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00702/16/2024
    Labeler - CVS Pharmacy (062312574)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(51316-831)
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