RADIBAN (POTASSIUM IODIDE) TABLET [UNITED DOUGLAS PHARM., INC.]

RADIBAN (POTASSIUM IODIDE) TABLET [UNITED DOUGLAS PHARM., INC.]
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NDC 65697-513-01, 65697-513-11
Set ID 566c8453-bae5-4f96-bc82-30d4543c9895
Category HUMAN OTC DRUG LABEL
Packager United Douglas Pharm., Inc.
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet) .... Potassium Iodide 130 mg.

  • PURPOSE

    Purpose  ---   Thyroid Blocking

    Use  ---  Potassium iodide helps prevent radioactive iodine from getting into the thyroid gland during a nuclear radiation emergency.  Use along with other emergency measures recommended by public officials.

  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children.
  • INDICATIONS & USAGE


    Radiban (Potassium iodide tablet, USP) is a thyroid blocking medicine that helps prevent radioactive iodine from getting into the thyroid gland during a nuclear radiation emergency.  Use along with other emergency measures recommended by public officials.  Radiban is to be used only in the case of a nuclear radiation emergency.  It is not for everyday use.  Because of the stability of potassium iodide, the shelf life for Radiban is 10 years.
  • WARNINGS

    Allergy Alert: Iodine may cause an allergic reaction with one or more of the following symptoms:

    • Shortness of breath or wheezing
    • Swelling
    • Skin rash
    • Trouble breathing, speaking, or swallowing
    • Fever and joint pain
    Do not use if you have:

    • Ever had an allergic reaction to iodine
    • Nodular thyroid disease with heart disease
    • Hypocomplementemic vasculitis
    • Dermatitis herpetiformis

    Stop use and ask doctor if you have:

    • Allergic reaction.  Get medical help right away if you have trouble breathing, speaking, or swallowing; shortness of breath; wheezing; swelling of the mouth, tongue, or throat; or rash.
    • Irregular heartbeat or chest pain.  Get help right away.
    • Swelling of the hands or feet, fever, or joint pain.

  • DOSAGE & ADMINISTRATION

    Directions

    • Use only as directed by public officials in the event of a nuclear radiation emergency.
    • Do not take more than 1 dose in 24 hours.
    • Tablets can be whole or crushed and mixed with milk, water, orange juice, flat soda like cola, or raspberry syrup.

    Dosage:

            Adults over 18 years ........................................................................... 1 tablet (whole or crushed) daily (130 mg)

            Children over 12 years to 18 years who weigh at least 150 pounds .......... 1 Tablet (whole or crushed) daily (130 mg)

            Children over 12 years to 18 years who weigh less than 150 pounds .......  1/2 Tablet (whole or crushed) or 4 teaspoons of liquid mix daily (65 mg)

            Children over 3 years to 12 years ........................................................   1/2 Tablet (whole or crushed) or 4 teaspoons of liquid mix daily (65 mg)

            Children over 1 month to 3 years .........................................................    2 teaspoons of liquid mix daily (32.5 mg)

            Infants at birth to 1 month ...................................................................    1 teaspoon of liquid mix daily (16.25 mg)

    The liquid mixture should be given to infants, young children, and any others who cannot swallow tablets; see consumer package insert on how to make a liquid mixture.


  • INACTIVE INGREDIENT


    Inactive Ingredients: Microcrystalline cellulose, Lactose hydrate, Light Anhydrous Silicic Acid, Magnesium Stearate
  • PRINCIPAL DISPLAY PANEL

    Radiban Label TextRadiban Label

  • PATIENT PACKAGE INSERT

    Radiban Insert textRadiban Insert

  • INGREDIENTS AND APPEARANCE
    RADIBAN 
    potassium iodide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65697-513
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Potassium Iodide (UNII: 1C4QK22F9J) (Iodine - UNII:9679TC07X4) Potassium Iodide130 mg
    Inactive Ingredients
    Ingredient NameStrength
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Product Characteristics
    Coloryellow (Very light yellow - almost white tablet) Score2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code UT;I
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65697-513-1110 in 1 BOX
    1NDC:65697-513-011 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only12/20/2011
    Labeler - United Douglas Pharm., Inc. (001444350)
    Registrant - United Douglas Pharm., Inc. (001444350)
    Establishment
    NameAddressID/FEIBusiness Operations
    United Douglas Pharm., Inc.001444350pack, label
    Establishment
    NameAddressID/FEIBusiness Operations
    Korea United Pharm Inc.688016534manufacture

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