RADIBAN- potassium iodide tablet

Radiban by

Drug Labeling and Warnings

Radiban by is a Otc medication manufactured, distributed, or labeled by United Douglas Pharm., Inc., Korea United Pharm Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Text

PATIENT PACKAGE INSERT

Radiban Insert text

INGREDIENTS AND APPEARANCE

RADIBAN 
potassium iodide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65697-513
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Potassium Iodide (UNII: 1C4QK22F9J) (Iodine - UNII:9679TC07X4)	Potassium Iodide	130 mg

Inactive Ingredients
Ingredient Name	Strength
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Lactose Monohydrate (UNII: EWQ57Q8I5X)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Magnesium Stearate (UNII: 70097M6I30)

Product Characteristics
Color	yellow (Very light yellow - almost white tablet)	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	UT;I
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65697-513-11	10 in 1 BOX
1	NDC: 65697-513-01	1 in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		12/20/2011

Labeler - United Douglas Pharm., Inc. (001444350)

Registrant - United Douglas Pharm., Inc. (001444350)

Establishment
Name	Address	ID/FEI	Business Operations
United Douglas Pharm., Inc.		001444350	pack, label

Establishment
Name	Address	ID/FEI	Business Operations
Korea United Pharm Inc.		688016534	manufacture