RADIBAN - potassium iodide tablet 
United Douglas Pharm., Inc.

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

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.


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.

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

Do not use if you have:

Stop use and ask doctor if you have:


Directions

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 Ingredients: Microcrystalline cellulose, Lactose hydrate, Light Anhydrous Silicic Acid, Magnesium Stearate

Radiban Label TextRadiban Label

Radiban Insert textRadiban Insert

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

Revised: 12/2011
Document Id: 8026afa4-db2b-4aad-b2c6-b3a0046a5fd1
Set id: 566c8453-bae5-4f96-bc82-30d4543c9895
Version: 3
Effective Time: 20111221
 
United Douglas Pharm., Inc.