Label: HEALTH MART PHARMACY- mineral oil

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

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 April 15, 2019

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

  • Active ingredient

    Mineral oil 99.9%

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  • Purpose

    Lubricant laxative

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  • Use

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

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  • Do not use

    • if you have difficulty swallowing
    • in children under 6 years of age
    • if you are pregnant
    • for a period longer than 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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  • 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.
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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 breast-feeding,

    ask a health professional before use

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  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

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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

    adults and children 12 years of age and over - 1 to 3 Tablespoons (15 - 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

    children 6 to under 12 years of age - 1 to 3 teaspoons (5 - 15 mL) maximum 3 teaspoons (15 mL) in 24 hours

    children under 6 years of age - do not use, consult a doctor

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  • Other information

    keep tightly closed.  Protect from sunlight.

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  • Inactive ingredients

    mixed tocopherols (added as a stabilizer)

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  • Adverse Reactions Section

    Another Quality Product Distributed by McKesson

    One Post Street

    San Francisco, CA 94104

    Money Back Guarantee

    www.healthmart.com/healthmartbrand

    831.000/831AA

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  • Principal Display Panel

    HealthMart

    PHARMACY

    mineral oil

    U.S.P.

    lubricant laxative

    for relief of occasional constipation

    odorless/tasteless/colorless

    SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

    16 FL OZ (1PT) 473 mL

    image description

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  • INGREDIENTS AND APPEARANCE
    HEALTH MART PHARMACY 
    mineral oil
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0831
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 999 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62011-0831-1 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/13/2002
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 11/13/2002
    Labeler - McKesson (177667227)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(62011-0831)
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