Label: MINERAL OIL solution

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

Drug Label Information

Updated January 8, 2025

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

  • Active Ingredients

    Mineral Oil USP

  • Purpose

    Lubricant Laxative

  • Use:

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

  • WARNINGS:

    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 persist over a period of 2 weeks.

    Ask a Doctor or Pharmacist before use if you are: * presently taking a stool softener * taking any other drug. Take this product 2 or more hours before or after drugs. Laxatives may affect how other drugs work. Frequent or prolonged use may result in dependence.

    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 care professional before use.

    Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. In case of eye contact, flush with water.

  • DOSAGE & ADMINISTRATION

    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 mL to 45 mL), maximum 3 Tablespoons (45 mL) in 24 hours
    Children 6 to under 12 years of age 1 to 3 teaspoons (5 mL to 15 mL), maximum 3 teaspoons (15 mL) in 24 hours
    Children under 6 years Do not use. Consult a doctor

    Other information: Keep tightly closed. Protect from sunlight. For more info call 800-447-1006.

    Inactive ingredients: Mixed tocopherols (added as a stabilizer)

    NDC: 48433-202-30 Mineral Oil USP 30 mL Unit Dose Cup

    Mfd. in the U.S.A.
    Distributed by: Safecor Health, LLC
    4060 Business Park Drive, Columbus, OH 43204
    Rev: 05/2019 PN5471

  • Principal Display Panel - Lid Label

    Delivers 30 mL

    NDC 48433-202-30

    Mineral Oil USP

    Lubricant Laxative

    DO NOT TAKE WITH MEALS

    348433202302

    Pkg By: Safecor Health, LLC

    Columbus, OH 43204

    Principal Display Panel - Lid Label
  • INGREDIENTS AND APPEARANCE
    MINERAL OIL 
    mineral oil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-202
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL1000 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48433-202-3030 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product10/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM33410/01/2014
    Labeler - Safecor Health, LLC (828269675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safecor Health, LLC078805287MANUFACTURE(48433-202)