Label: MINERAL OIL- mineral oil liquid 

  • Label RSS
  • NDC Code(s): 41190-831-43
  • Packager: WAKEFERN FOOD CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/13

If you are a consumer or patient please visit this version.

  • Active ingredient

    Mineral oil 99.9%

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  • Purpose

    Lubricant laxative

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  • Use

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

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  • 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
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  • 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
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  • 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
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  • When using this product

    do not take with meals.  Take only at bedtime.

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  • 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.

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  • If breast feeding

    ask a health professional before use

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  • Keep out of reach of children

    in case of overdose, get medical help or contact a Poison Control Center right away

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  • 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

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  • Other information

    keep tightly closed.  Protect from sunlight

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  • Inactive ingredients

    mixed tocopherols (added as a stabilizer)

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  • Disclaimer

    This product is not manufactured or distributed by Roberts Pharmaceutical Corp., distributor of Roberts Mineral Oil

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  • Adverse reactions

    DISTRIBUTED BY WAKEFERN FOOD CORPORATION

    5000 RIVERSIDE DR

    KEASBEY, NJ, 08832

    1-800-SHOPRITE

    www.shoprite.com

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  • Principal Display Panel

    Compare to active ingredient Roberts Mineral Oil

    ShopRite

    MINERAL 

    OIL

    USP

    LUBRICANT LAXATIVE

    For relief of Occasional Constipation

    Odorless - Tasteless - Colorless

    SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

    16 FL OZ (1 PT) 473 mL

    Made in the USA with US and foreign components

    image description

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  • INGREDIENTS AND APPEARANCE
    MINERAL OIL 
    mineral oil liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41190-831
    Route of Administration ORAL, TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MINERAL OIL (MINERAL OIL) MINERAL OIL 999 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    TOCOPHEROL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41190-831-43 473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 07/15/1989
    Labeler - WAKEFERN FOOD CORPORATION (069722418)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(41190-831)
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