DESCRIPTION SECTION.


DESCRIPTION. Each white, round, cross-scored--the name IOSAT stamped on one side--tablet contains 130 mg of potassium iodide.

DOSAGE & ADMINISTRATION SECTION.


Directions. use as directed by public officials in the event of nuclear radiation emergencydo not take more than dose in 24 hourstablets can be whole or crushed and mixed in milk, baby formula, water, orange juice, flat soda like cola, or raspberry syrupThe liquid mixture should be given to infants, young children, and others who cannot swallow tablets; see consumer package insert on how to make liquid mixture.AgeDoseAdults over 18 years tablet (whole or crushed) daily (130 mg)Children over 12 years to 18 years who weigh at least 150 pounds1 tablet (whole or crushed) daily (130 mg)Children over 12 years to 18 years who weigh less than 150 pounds1/2 tablet (whole or crushed) daily (65 mg)Children over years to 12 years1/2 tablet (whole or crushed) daily (65 mg)Children over month to years32.5 mg daily as directed in the consumer package insertBirth to month16.25 mg daily as directed in the consumer package insertIf pregnant, breastfeeding, have baby up to month of age or have thyroid disease (except nodular thyroid disease with heart disease), take as directed above and contact doctor as soon as possible.. use as directed by public officials in the event of nuclear radiation emergency. do not take more than dose in 24 hours. tablets can be whole or crushed and mixed in milk, baby formula, water, orange juice, flat soda like cola, or raspberry syrup. If pregnant, breastfeeding, have baby up to month of age or have thyroid disease (except nodular thyroid disease with heart disease), take as directed above and contact doctor as soon as possible.

HOW SUPPLIED SECTION.


HOW SUPPLIED. IOSAT(TM) (Potassium Iodide Tablets, USP 130 mg) Each white, round tablet, cross-scored on one side and the IOSAT name on the other, contains 130 mg potassium iodide. NDC 51803-001-01: 14 Unit dose, Foil Sealed, 130 mg Tablets. NDC 51803-001-10: 10 14 Unit dose, Foiled Sealed 130 mg tablets (140 tablets) in Clear Plastic Bag. Also available: IOSAT(TM) (Potassium Iodide Tablets, USP 65 mg) Packages of 20 tablets. Each white, round tablet, cross-scored on one side and the IOSAT name on the other, contains 65 mg potassium iodide. NDC 51803-002-01: X 10 Unit dose, Foil Sealed, 65 mg Tablets (20 Tablets).

INACTIVE INGREDIENT SECTION.


Inactive ingredients. magnesium stearate, microcrystalline cellulose, silica gel, sodium thiosulfate.

INDICATIONS & USAGE SECTION.


Uses. Helps prevent radioactive iodine from getting into the thyroid gland during nuclear radiation emergency. Use along with other emergency measures recommended by public officials.

OTC - ACTIVE INGREDIENT SECTION.


Active Ingredients (in each tablet . Potassium iodide 130 mg.

OTC - DO NOT USE SECTION.


Do not use if you have ever had an allergic reaction to iodinenodular thyroid disease with heart diseasehypocomplementemic vasculitisdermatitis herpetiformis. ever had an allergic reaction to iodine. nodular thyroid disease with heart disease. hypocomplementemic vasculitis. dermatitis herpetiformis.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep out of reach of children.. In case of overdose, get medical help or contact Poison Control Center right away.

OTC - PURPOSE SECTION.


Purpose. Thyroid blocking.

OTC - QUESTIONS SECTION.


Questions or Comments. call toll free 1-866-463-6754.

OTC - STOP USE SECTION.


Stop use and ask doctor if you have an 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 medical help right away.swelling of the hands or feet, fever, or joint pain.. an 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 medical help right away.. swelling of the hands or feet, fever, or joint pain.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL. IOSAT(TM) (Potassium Iodide Tablets, USP 130 mg). iosat 130 package label.

SPL PATIENT PACKAGE INSERT SECTION.


Consumer Package Insert. IOSAT(TM)(Potassium Iodide Tablets USP, 130 mg) (Abbreviated KI) Take potassium iodide (KI) only when public officials tell you. In nuclear radiation emergency, radioactive iodine could be released into the air. KI protects only the thyroid gland from uptake of radioactive iodine. Therefore, KI should be used along with other emergency measures that will be recommended to you by public officials. If you are told to take this medicine, take it time every 24 hours. Do not take it more often. More KI will not help you. Too much KI may increase the chances of side effects. Do not take this medicine if you know you are allergic to iodine (see SIDE EFFECTS below).

SPL UNCLASSIFIED SECTION.


Drug Facts.

STORAGE AND HANDLING SECTION.


STORAGE AND HANDLING. Store at 20-25C (68-77F). Keep dry and foil intact.

WARNINGS SECTION.


Warnings. Allergy alert: Iodine may cause an allergic reaction with or more of the following symptoms: shortness of breath or wheezingswellingskin rashtrouble breathing, speaking or swallowingfever and joint pain. 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 iodinenodular thyroid disease with heart diseasehypocomplementemic vasculitisdermatitis herpetiformis. 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 an 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 medical help right away.swelling of the hands or feet, fever, or joint pain.. an 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 medical help right away.. swelling of the hands or feet, fever, or joint pain.. Keep out of reach of children.. In case of overdose, get medical help or contact Poison Control Center right away.