Label: MINERAL OIL oil

  • NDC Code(s): 63868-938-16
  • Packager: QUALITY CHOICE (Chain Drug Marketing Association)
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 4, 2022

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  • Active ingredient

    Mineral oil 100%

  • Purpose

    intestinal lubricant

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 6 to 8 hours
  • Warnings

    Do not use

    • if you have difficulty swallowing
    • in children under 12 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

    • stomach reflux
    • 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

    • 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) immediately.

  • Directions

    • do not take with meals
    • take only at bedtime
    • may be taken as a single daily dose or in divided doses
     age dose
     adults & children over 12 years1 to 3 tablespoons (15 to 45 mL)
     children under 12 yearsconsult a doctor
  • Other information

    • keep tightly closes
    • protect from sunlight
  • Inactive ingredients

    d-alpha tocopherol (Vitamin E) as stabilizer

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Mineral Oil

    Lubricant Laxative

    Odorless

    Tasteless

    Colorless

    FL OZ (mL)

    Distributed by C.D.M.A Inc.©

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

    248-449-9300

  • Package Label

    Mineral Oil 100%

    Quality Choice Mineral Oil

  • INGREDIENTS AND APPEARANCE
    MINERAL OIL 
    mineral oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-938
    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:63868-938-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/201405/30/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/31/201405/30/2025
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
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