Label: MINERAL OIL liquid

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

Drug Label Information

Updated February 5, 2024

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Distributed by: McKesson Corp. Via Strategic Services LLC.

    Memphis, TN 38141 

    Money Back Guarantee

    www.fosterandthrive.com

  • 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.

  • 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 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

    (c) 2023 McKesson Corporaation

    You may report serious side effects to 833-358-6431

    Monday to Friday 9:00am to 7:00pm EST

  • Principal Display Panel

    NDC 17856-1110-01

    image 1

  • INGREDIENTS AND APPEARANCE
    MINERAL OIL 
    mineral oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-1110(NDC:70677-1110)
    Route of AdministrationORAL
    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:17856-1110-150 in 1 BOX, UNIT-DOSE02/05/2024
    1NDC:17856-1110-230 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM04/17/2023
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTIONS360804194repack(17856-1110)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!