Label: MINERAL OIL liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 2, 2025

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

  • Claims

    Visit us at: Rexall.com or call 1-866-4-REXALL

    Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc.

  • 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 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)

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY OLD EAST MAIN CO

    100 MISSION RIDGE GOODLETTSVILLE, TN 37072 

    MADE IN THE USA WITH US AND FOREIGN COMPONENTS

  • principal display panel

    Since 1903

    Rexall ®

    Mineral oil U.S.P.

    Lubricant Laxative

    • For relief of occasional constipation
    • Odorless, tasteless, colorless

    SEALED WITH PRINTED SEAL UNDER CAP FOR YOUR PROTECTION

    16 FL OZ (1 PT) 473 mL

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  • INGREDIENTS AND APPEARANCE
    MINERAL OIL 
    mineral oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-831
    Route of AdministrationORAL, TOPICAL
    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:55910-831-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/16/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00709/16/2010
    Labeler - Old East Main CO. (068331990)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(55910-831)