Label: MINERAL OIL - mineral oil oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/09

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

  • Active Ingredient

    Mineral Oil

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  • PURPOSE

    intestinal lubricant

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  • Uses

    relieves occasional constipation (irregularity)

    generally produces bowel movement in 6 to 8 hours

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  • 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 one week

    if you are bedridden or aged



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  • 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


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  • When using this product

    do not take with meals

    take only at bedtime

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  • 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

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  • If pregnant or breast feeding,

    ask a health professional before use

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  • Keep this and all drugs out of the reach of children

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately

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  • 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 and children over 12 years         1 to 3 tablespoons (15 to 45 ml)

                                                              maximum3 tablespoons (45mL) in 24 hours



    children 6 years to under 12 years         1 to 3 tablespoons (15 to 45 ml)

                                                              maximum3 tablespoons (45mL) in 24 hours

    children under 6 years                           do not use, consult a doctor
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  • Other Information

    keep tightly closed

    protect from sunlight


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  • Inactive Ingredient

    d-alpha tocopherol (Vitamin E) as stabilizer

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  • Principal Display Panel

    CVS Pharmacy

    Mineral Oil

    USP

    Lubricant Laxative

    Odorless

    Tasteless

    Colorless

    32 FL OZ (1 QT) 946 mL

    image of label

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  • INGREDIENTS AND APPEARANCE
    MINERAL OIL 
    mineral oil oil
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-460
    Route of Administration TOPICAL, ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MINERAL OIL (MINERAL OIL) MINERAL OIL 15 mL  in 15 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALPHA-TOCOPHEROL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-460-16 946 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 07/07/2009
    Labeler - CVS (062312574)
    Registrant - Aaron Industries Inc. (030119387)
    Establishment
    Name Address ID/FEI Business Operations
    Aaron Industries Inc. 030119387 manufacture, analysis
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