IOSAT POTASSIUM IODIDE ANBEX INC. FDA Approved Each white, round, cross-scored—the name IOSAT stamped on one side—tablet contains 130 mg of potassium iodide.
Generic: POTASSIUM IODIDE
Mfr: ANBEX INC. FDA OTC
FunFoxMeds box
Substance Potassium Iodide
Route
ORAL
Applications
NDA018664

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients (in each tablet ) Potassium iodide 130 mg
Inactive Ingredients
Inactive ingredients magnesium stearate microcrystalline cellulose silica gel sodium thiosulfate
Strengths
130 mg 14 unit 65 mg 10 unit
Quantities
140 tablets 20 tablets 130 pack
Treats Conditions
Uses 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 Indications Iosat Potassium Iodide Tablets Usp 130 Mg Is A Thyroid Blocking Medicine That Is Used In A Nuclear Radiation Emergency Only
Pill Appearance
Shape: round Color: white Imprint: IOSAT

Identifiers & Packaging

Container Type UNKNOWN
UNII
1C4QK22F9J
Packaging

HOW SUPPLIED IOSAT™ (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 X 14 Unit dose, Foiled Sealed 130 mg tablets (140 tablets) in a Clear Plastic Bag. Also available: IOSAT™ (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: 2 X 10 Unit dose, Foil Sealed, 65 mg Tablets (20 Tablets).; PRINCIPAL DISPLAY PANEL IOSAT™ (Potassium Iodide Tablets, USP 130 mg) iosat 130 package label

Package Descriptions
  • HOW SUPPLIED IOSAT™ (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 X 14 Unit dose, Foiled Sealed 130 mg tablets (140 tablets) in a Clear Plastic Bag. Also available: IOSAT™ (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: 2 X 10 Unit dose, Foil Sealed, 65 mg Tablets (20 Tablets).
  • PRINCIPAL DISPLAY PANEL IOSAT™ (Potassium Iodide Tablets, USP 130 mg) iosat 130 package label

Overview

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

Indications & Usage

Uses 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. INDICATIONS IOSAT™ (Potassium Iodide tablets, USP, 130 mg) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.

Dosage & Administration

Directions use 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 in milk, baby formula, water, orange juice, flat soda like cola, or raspberry syrup The liquid mixture should be given to infants, young children, and others who cannot swallow tablets; see consumer package insert on how to make a liquid mixture. Age Dose 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) daily (65 mg) Children over 3 years to 12 years 1/2 tablet (whole or crushed) daily (65 mg) Children over 1 month to 3 years 32.5 mg daily as directed in the consumer package insert Birth to 1 month 16.25 mg daily as directed in the consumer package insert If pregnant, breastfeeding, have a baby up to 1 month of age or have thyroid disease (except nodular thyroid disease with heart disease), take as directed above and contact a doctor as soon as possible.

Warnings & Precautions
Warnings Allergy alert: Iodine may cause an allergic reaction with 1 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 a 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. WARNING People who are allergic to iodine, have dermatitis herpetiformis or hypocomplementemic vasculitis, or have nodular thyroid disease with heart disease should not take KI. Keep out of the reach of children. In case of an allergic reaction (difficulty breathing, speaking or swallowing; wheezing; shortness of breath or swelling of the mouth or throat), call 911 or get medical care right away. In case of overdose, get medical help or call a Poison Control Center right away. HOW POTASSIUM IODIDE WORKS Certain forms of iodine help your thyroid gland work right. Most people get the iodine they need from foods like iodized salt or fish. The thyroid can “store” or hold only a certain amount of iodine. In nuclear radiation emergency, radioactive iodine may be released in the air. This material may be breathed or swallowed. It may enter the thyroid gland and damage it. The damage would probably not show itself for years. Children are most likely to have thyroid damage. If you take KI, it will block or reduce the chances that radioactive iodine will enter your thyroid gland. WHO SHOULD NOT TAKE POTASSIUM IODIDE People should avoid KI if they are allergic to iodine, have dermatitis herpetiformis or hypocomplementemic vasculitis, or have nodular thyroid disease with heart disease, because these conditions may increase the chances of side effects to iodine. HOW AND WHEN TO TAKE POTASSIUM IODIDE KI should be taken as soon as possible after public officials tell you. If you are told to repeat the dose, you should take the second dose 24 hours after the first dose. Do not take it sooner. More KI will not help you because the thyroid can “hold” only certain amounts of iodine. Taking more than 1 dose per day will increase the chances of side effects. The public officials will tell you how many days to take KI. You should take KI until the chances of major exposure to radioactive iodine by breathing or swallowing stops. SIDE EFFECTS Short-term use of KI at the recommended dose is safe. You should not take this drug for longer than you are told. Possible side effects include: swelling of the salivary glands, nausea, vomiting, diarrhea, stomach ache, fever, headache, metallic taste, and allergic reactions. Allergic reaction can include skin rashes such as hives swelling of various parts of the body such as the face, lips, tongue, throat, hands or feet fever with joint pain trouble breathing, speaking or swallowing wheezing or shortness of breath Get medical attention right away if you have trouble breathing, speaking or swallowing; wheezing; shortness of breath; or swelling of the mouth, tongue or throat. Taking iodide, in rare cases, may cause overactivity of the thyroid gland, underactivity of the thyroid gland, or enlargement of the thyroid gland (goiter). Symptoms of an overactive thyroid gland may include an irregular heartbeat and chest pain. Patients with thyroid disease are more likely to get these side effects. Babies under 1 month of age are more likely to get an underactive thyroid gland (hypothyroidism). WHAT TO DO IF SIDE EFFECTS OCCUR Stop taking KI and call a doctor if you have one of the following symptoms: swelling of the face, hands or feet fever and joint pain skin rash Stop taking KI and get medical help right away if you have one or more of the following symptoms: trouble breathing, speaking or swallowing shortness of breath or wheezing swelling of the lips, tongue or throat irregular heart beat or chest pain
Purpose

Purpose Thyroid blocking

Do Not Use

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 & Ask a Doctor

Stop use and ask a 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.

Keep Out of Reach of Children

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

Storage & Handling

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

Questions

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


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