Label: DYNAREX LAXATIVE- mineral oil liquid

  • 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 5, 2014

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  • Active Ingredient

    Active Ingredient                         Purpose

    Mineral oil                                    Intestinal lubricant

  • Purpose

    Purpose

    Relieves occassional constipation (irregularity).

  • Warnings

    Warnings

    Do not use:

    • If you have difficulty swallowing.
    • In children under 12 years of age.
    • If you are pregnant.
    • For a period longer than 1 week.
    • If you are bedridden or aged.
  • Indications & Usage

    Indications & Usage

    • For relief of occassional constipation (irregularity).

    When using this product 

    • Do not take with meals
    • Take only at bedtime

    Ask a doctor before use if you have

    • Stomach reflux
    • Abdominal pain, nausea, or vomiting
    • Notice a sudden change in bowel habits that persist over a period of 2 weeks

    Stop use and ask a doctor if

    • Rectal bleeding or failure to have a bowel movementafter use. These could be signs of a serious condition.
  • Dosage & Administration

    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)

          Maximum 3 tablespoons (45ml) in 24 hours

    children under

    12 years

          Consult a doctor

  • Keep Out Of Reach Of Children

    Keep Out Of Reach Of Children

    • 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.
  • Other information

    Other information

    • Keep tightly closed
    • Protect from sunlight
  • Inactive ingredients

    Inactive ingredients: Butylated hydroxytoluene (BHT), Butylated hydroxyanisole (BHA)

  • Principal Display Panel

    Dynarex Mineral Oil Laxative
    4270 Min oil.jpg

    4270 Mineral oil

  • INGREDIENTS AND APPEARANCE
    DYNAREX LAXATIVE 
    mineral oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-404
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL99 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    Butylated hydroxyanisole (UNII: REK4960K2U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-404-01473 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/05/2014
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mistair Health & Hygiene Pvt Ltd677604297manufacture(67777-404)
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