Label: HUMCO MINERAL OIL HEAVY- mineral oil liquid

  • NDC Code(s): 0395-1685-28
  • Packager: Humco Holding Group, Inc.
  • 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 March 17, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Mineral Oil Heavy

  • Purpose

    Laxative

  • Use

    For relief of occasional constipation or irregularit. Generally produces bowel movement in 6 to 8 hrs.

  • Warnings

    Do not take this product if you have abdominal pain, nausea, vomiting, change in bowel habits persisting more than 2 weeks, rectal bleeding or kidney failure are present, or use for a period of longer than 1 week unless directed by a doctor. Frequent or prolonged use may result in the dependence on laxatives.

    Do not administer to infants or young children, bedridden or aged patients unless directed by a doctor.

  • Ask a doctor before use if

    you are currently taking a stool softener laxative.

    If pregnant or brest feeding ask a health professional before use.

  • When using this Product discotinue use

    and consult a doctor if there is a failure to have a bowel movement after use.

  • Keep out of reach of children

    In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. In case of eye contact wash gently with water for 15 minutes.

  • Directions

    Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime.

    Children 6 to 12 yrs. of age: 1 to 3 teaspoonfuls at bedtime.

    Children under 6 yrs. of age: Consult a doctor before use.

  • Inactive ingredient

    dl-alpha-tocopherol as a preservative.

  • Other information

    Keep tightly closed and protect from direct light.

  • Principal display panel

    capture(2)

  • INGREDIENTS AND APPEARANCE
    HUMCO MINERAL OIL HEAVY 
    mineral oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-1685
    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 ACETATE, DL- (UNII: WR1WPI7EW8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-1685-283800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/25/1998
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(0395-1685) , analysis(0395-1685) , pack(0395-1685) , label(0395-1685)