Label: MINERAL OIL oil

  • NDC Code(s): 49580-0334-6
  • Packager: P & L Development, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 15, 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 ingestion, 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 tablespoons (45 mL) in 24 hours
    • children under 12 years, consult a doctor
  • Other information

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

    Vitamin E as stabilizer

  • Principal Display Panel

    Mineral Oil

    lubricant laxative

    • odorless
    • tasteless
    • colorless

    FL OZ (mL)

    Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

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

    Manufactured by:

    PL Developments

    1874 Hwy 72 W,

    Clinton, SC 29325

  • Package Label

    Mineral oil 100%

    ReadyinCase Mineral Oil

  • INGREDIENTS AND APPEARANCE
    MINERAL OIL 
    mineral oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0334
    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:49580-0334-6473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00708/31/2014
    Labeler - P & L Development, LLC (101896231)
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