On this page

IOSAT

Potassium Iodide · Tablet

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
IOSAT
Generic name
Potassium Iodide
Dosage form
Tablet
Route
Oral
Marketing category
NDA · NDA
Labeler
Anbex Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
4
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Potassium Iodide 130 mg/1 312539 View
Potassium Iodide 65 mg/1 312539 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
6

Regulatory status

Source: Drugs@FDANDC Directory
Application number
018664
Application type
NDA · New Drug Application
Approval date
October 14, 1982
Sponsor
ANBEX
Products on application
2
Submissions recorded
9
Products approved under application 018664.
Product Trade name Form Strength Ingredient Status TE Flags
018664-001 IOSAT TABLET POTASSIUM IODIDE Over-the-counter — RLD RS
018664-002 IOSAT TABLET POTASSIUM IODIDE Over-the-counter — RLD

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 018664.
Type No. Action Status Date Review
Supplement 18 Manufacturing (CMC) Approved December 20, 2016 Standard
Supplement 17 Manufacturing (CMC) Approved June 6, 2016 —
Supplement 16 Manufacturing (CMC) Approved June 17, 2015 —
Supplement 15 Manufacturing (CMC) Approved March 3, 2015 —
Supplement 13 Manufacturing (CMC) Approved May 12, 2011 —
Supplement 7 Labeling Approved January 14, 2005 —
Supplement 2 Manufacturing (CMC) Approved September 13, 2000 —
Supplement 1 Manufacturing (CMC) Approved November 4, 1985 —
Original application 1 Approved October 14, 1982 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251003). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251003 HUMAN OTC DRUG · 20251003

Indications and Usage

openFDA Drug Labeling

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

Purpose Thyroid blocking

Dosage and Administration

openFDA Drug Labeling

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 2 tablets (whole or crushed) daily (130 mg) Children over 12 years to 18 years who weigh at least 150 pounds 2 tablets (whole or crushed) daily (130 mg) Children over 12 years to 18 years who weigh less than 150 pounds 1 tablet (whole or crushed) daily (65 mg) Children over 3 years to 12 years 1 tablet (whole or crushed) daily (65 mg) Children over 1 month to 3 years 1/2 tablet (crushed) 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 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 …

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.

Description

openFDA Drug Labeling

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

Active Ingredient

openFDA Drug Labeling

Active Ingredients (in each tablet ) Potassium iodide 130 mg

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED IOSATTM (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). IOSATTM (Potassium Iodide Tablets, USP 65 mg) Packages of 14 tablets. Each white, round tablet, cross-scored on one side and the IOSAT name on the other, contains 65 mg potassium iodide. NDC 51803-002-02: 14 Unit dose, Foil Sealed, 65 mg Tablets (14 Tablets). Also available: IOSATTM (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.

Adverse event reports

Source: openFDA FAERS
2,100
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: POTASSIUM IODIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
51803-001-01 51803-001 Anbex Inc. 14 TABLET in 1 PACKAGE (51803-001-01) October 14, 1982
51803-001-10 51803-001 Anbex Inc. 10 PACKAGE in 1 BAG (51803-001-10) / 14 TABLET in 1 PACKAGE (51803-001-01) August 16, 2016
51803-002-01 51803-002 Anbex Inc. 20 TABLET in 1 PACKAGE (51803-002-01) May 1, 2013
51803-002-02 51803-002 Anbex Inc. 14 TABLET in 1 PACKAGE (51803-002-02) November 23, 2015
51803-001 51803-001 Anbex Inc. — October 14, 1982
51803-002 51803-002 Anbex Inc. — May 1, 2013

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.