DYNAREX LAXATIVE (MINERAL OIL) LIQUID [DYNAREX CORPORATION]

DYNAREX LAXATIVE (MINERAL OIL) LIQUID [DYNAREX CORPORATION]
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NDC 67777-404-01
Set ID a56267f3-2a8b-4a70-9ce5-233ddbf13db6
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART334
  • 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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