Radiban

Manufacturer
United Douglas Pharm., Inc. | Korea United Pharm Inc.
Effective date
2011-12-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:30:25

Label at a glance#

ProductRadiban
Active ingredientPotassium Iodide
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children.

INDICATIONS & USAGE SECTION


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 SECTION

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 SECTION

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 SECTION


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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Radiban Label TextRadiban LabelRadiban Label

SPL PATIENT PACKAGE INSERT SECTION

Radiban Insert textRadiban InsertRadiban Insert

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312539potassium iodide 130 MG Oral TabletPSN3
312539potassium iodide 130 MG Oral TabletSCD3
312539K+ Iodide 130 MG Oral TabletSY3
312539Pot Iodide 130 MG Oral TabletSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65697-513-112019-11-13C16284748780-197449f38-baf8-f6ea-e053-dbdaa90aa703566c8453-bae5-4f96-bc82-30d4543c9895

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65697-513-01Radiban1 in 1 PACKETTABLET13
65697-513-11Radiban10 in 1 BOXTABLET103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65697-513RADIBAN (POTASSIUM IODIDE) TABLET [UNITED DOUGLAS PHARM., INC.]32 package rows20111222_566c8453-bae5-4f96-bc82-30d4543c9895.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Potassium IodideACTIVE INGREDIENT1C4QK22F9J3
IodineACTIVE MOIETY9679TC07X43

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65697-51365697-513-01, 65697-513-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8026afa4-db2b-4aad-b2c6-b3a0046a5fd1566c8453-bae5-4f96-bc82-30d4543c98952011-12-21WarningsExact identifier
spl id: 8026afa4-db2b-4aad-b2c6-b3a0046a5fd1
spl set id: 566c8453-bae5-4f96-bc82-30d4543c9895

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.