Label: PREMIER VALUE- mineral oil

  • NDC Code(s): 68016-831-43
  • Packager: Pharmacy Value Alliance LLC
  • 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 March 22, 2021

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

  • Active ingredient

    Mineral oil 99.9%

  • Purpose

    Lubricant laxative

  • Use

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

  • 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
  • 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 work.
  • 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 signs of a 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 - 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

  • Other information

    keep tightly closed.  Protect from sunlight

  • Inactive ingredients

    mixed tocopherols (added as a stabilizer)

  • Questions?

    Call 1-888-593-0593

  • Adverse Reaction

    Distributed by: Pharmacy Value Alliance LLC

    407 East Lancaster Avenue, Wayne, PA 19087   www.emersongroup.com

    If for any reason you are not satisfied with this product,

    please return it to the store where purchased for a full refund.

    831.000/831AA

  • principal display panel

    Premier

    Value

    Mineral Oil usp

    lubricant laxative

    odorless - tasteless - colorless

    for relief of occasional constipation

    SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

    16 FL OZ (1PT) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE 
    mineral oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-831
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL999 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-831-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/19/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/19/2009
    Labeler - Pharmacy Value Alliance LLC (101668460)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(68016-831)