OIL (MINERAL OIL) OIL [VI-JON]

OIL (MINERAL OIL) OIL [VI-JON]
PDF | XML

NDC 0869-0831-43
Set ID 3ffdbd3d-a711-4706-9596-c287e3957a93
Category HUMAN OTC DRUG LABEL
Packager Vi-Jon, LLC
Generic Name
Product Class
Product Number
Application Number PART334
  • Active ingredient

    Mineral oil 99.9%

  • Purpose

    Lubricant laxative

  • Use

    for relief of occasional constipation (irregularity).  Generally productes 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 of 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 wrok.
  • 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 signd of 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 12 years of age - 1 to 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)

  • Adverse reactions section

    *This product is not manufactured or distributed by Roberts Pharmaceutical Corp., distributor of Roberts Mineral Oil.

    Distributed by: Vi-Jon

    One Swan Drive

    Smyrna, TN 37167

    831.000/831AA

  • principal display panel

    SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

    mountain

    falls

    for relief of occasional constipation

    odorless, tasteless & colorless

    lubricant laxatice

    mineral oil u.s.p.

    Made in the USA

    with US and foreign parts

    16 FL OZ (473 mL)

    image description

  • principal display panel

    NDC 0869-0831-43

    swan

    MINERAL OIL

    U.S.P. LUBRICANT LAXATIVE

    • For Relief of Occasional Constipation
    • Odorless, Tastless, Colorless

    COMPARE TO ACTIVE INGREDIENT OF ROBERTS MINERAL OIL

    SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION.

    16 FL OZ (1 PT) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    OIL 
    mineral oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0831
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0869-0831-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/15/1989
    Labeler - Vi-Jon, LLC (790752542)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(0869-0831)