Label: MINERAL OIL oil

  • NDC Code(s): 63941-334-16
  • Packager: Best Choice (Valu Merchandisers Company)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 20, 2024

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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 women, 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.

    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
      • 1 to 3 tablespoons (15 to 45 mL)
      • maximum 3 tablespoon (45 mL) in 24 hours
    • children under 12 years, consult a doctor
  • Other information

    • keep tightly closes
    • protect from direct light
  • Inactive ingredients

    Vitamin E as stabilizer

  • Principal Display Panel

    Mineral Oil

    Lubricant Laxative U.S.P.

    •Odorless • Tasteless • Colorless

    FL OZ (mL)

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

    www.bestchoicebrand.com

    PROUDLY DISTRIBUTED BY:

    VALU MERCHANDISERS, CO.

    5000 KANSAS AVE

    KANSAS CITY, KS 66106

    Questions or comments?

    Call 1-877-753-3935

    Monday-Friday 9AM-5PM EST

  • Package Label

    Mineral oil 100%

    Best Choice Mineral Oil

  • INGREDIENTS AND APPEARANCE
    MINERAL OIL 
    mineral oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-334
    Route of AdministrationORAL
    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:63941-334-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/31/201610/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00710/31/201610/31/2025
    Labeler - Best Choice (Valu Merchandisers Company) (868703513)
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