NDC 51803-002 Iosat
Potassium Iodide Tablet Oral

Product Information

Product Code51803-002
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Iosat
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Potassium Iodide
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Anbex Inc.
Labeler Code51803
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
NDA018664
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
05-01-2013
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)5 MM
Imprint(s)IOSAT
Score4

Product Packages

NDC 51803-002-01

Package Description: 20 TABLET in 1 PACKAGE

NDC 51803-002-02

Package Description: 14 TABLET in 1 PACKAGE

Product Details

Iosat is a human over the counter drug product labeled by Anbex Inc.. The generic name of Iosat is potassium iodide. The product's dosage form is tablet and is administered via oral form.


What are Iosat Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM THIOSULFATE ANHYDROUS (UNII: L0IYT1O31N)


* Please review the disclaimer below.

Patient Education

Potassium Iodide

Potassium Iodide is pronounced as (poe tas' ee um eye' oh dide)

Why is potassium iodide medication prescribed?
Potassium iodide is used to protect the thyroid gland from taking in radioactive iodine that may be released during a nuclear radiation emergency. Radioactive iodine can ...
[Read More]

* Please review the disclaimer below.

Iosat Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients (In Each Tablet )



Potassium iodide 65 mg


Purpose



Thyroid blocking


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.


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.


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.

    AgeDose
    Adults over 18 years 2 tablets (whole or crushed) daily (130 mg)
    Children over 12 years to 18 years who weigh at least 150 pounds2 tablets (whole or crushed) daily (130 mg)
    Children over 12 years to 18 years who weigh less than 150 pounds1 tablet (whole or crushed) daily (65 mg)
    Children over 3 years to 12 years1 tablet (whole or crushed) daily (65 mg)
    Children over 1 month to 3 years1/2 tablet (crushed) 32.5 mg daily as directed in the consumer package insert
    Birth to 1 month16.25 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.

Other Information



  • store at 20-25°C (68-77°F)
  • keep dry and foil intact
  • protect from light
  • do not throw away consumer package insert

Inactive Ingredients



magnesium stearate, microcrystalline cellulose, silica gel, sodium thiosulfate


Questions Or Comments?



call toll free 1-866-463-6754


Distributed By:



ANBEX INC.
1490 Quarterpath Road, Suite 5A #368
Williamsburg, VA 23185
www.anbex.com

ANBEX INC.
1490 Quarterpath Road, Suite 5A #368
Williamsburg, VA 23185
(866) 463-6754
www.anbex.com

SH905-2


Consumer Package Insert



IOSAT™

(Potassium Iodide Tablets USP, 65 mg)
(Abbreviated KI)

Take potassium iodide (KI) only when public officials tell you. In a 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 1 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).


Description



Each white, round, cross-scored—the name IOSAT stamped on one side—tablet contains 65 mg of potassium iodide.


Indications



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


Directions For Use



Use only as directed by public officials if a nuclear radiation emergency happens.

AgeDose
Adults over 18 years 2 tablets (whole or crushed) every day (130 mg)
Children over 12 years to 18 years who weigh at least 150 pounds2 tablets (whole or crushed) every day (130 mg)
Children over 12 years to 18 years who weigh less than 150 pounds1 tablet (whole or crushed) or 8 teaspoonfuls every day (65 mg)
Children over 3 years to 12 years1 tablet (whole or crushed) or 8 teaspoonfuls every day (65 mg)
Children over 1 month to 3 years4 teaspoonfuls every day (32.5 mg)
Birth to 1 month2 teaspoonfuls every day (16.25 mg)

Tablets can be crushed and mixed in many liquids. To take the tablet in liquid solution, use dosing directions under Making a Potassium Iodide Liquid Mixture.

Take KI every day (every 24 hours) as directed by public officials. Do not take more than 1 dose in 24 hours. More will not help you. Too much medicine may increase the chances of side effects.

Making a Potassium Iodide Liquid Mixture:

  • Put one 65 mg KI tablet into a small bowl and grind it into a fine powder using the back of a metal teaspoon against the inside of the bowl. The powder should not have any large pieces.
  • Add 4 teaspoonfuls of water to the crushed KI powder in the bowl and mix until the KI powder is dissolved in the water.
  • Take the KI water mixture solution made in step 2 and mix it with 4 teaspoonfuls of low fat white or chocolate milk, orange juice, flat soda, raspberry syrup, or infant formula.
  • The KI liquid mixture will keep for up to 7 days in the refrigerator. It is recommended that the KI liquid mixture be prepared weekly. Throw away unused portions.
  • The amount of KI (65 mg tablet) in the drink when mixed as described above is 8.125 mg per teaspoonful. The number of teaspoonfuls of the drink to give your child depends on your child’s age as described in the following table:

    Child's AgeGive your child this amount in teaspoonfuls
    Over 12 years to 18 years who weigh less than 150 pounds8 teaspoonfuls will give you a 65 mg dose
    Over 3 years to 12 years old8 teaspoonfuls will give you a 65 mg dose
    Over 1 month to 3 years old4 teaspoonfuls will give you a 32.5 mg dose
    Birth to 1 month2 teaspoonful will give you a 16.25 mg dose

    Note: This is the amount to give your child for one single dose in teaspoonfuls (not tablespoonfuls). You should give your child one dose each day as recommended by the public officials.

    Pregnant or breastfeeding women, or babies under 1 month of age: Take as directed above and call a doctor as soon as possible. Repeat dosing should be avoided. It is recommended that thyroid function be checked in babies less than 1 month of age that take KI. Women who are pregnant or breastfeeding should also be checked by a doctor if repeat dosing is necessary. Although these precautions should be taken, the benefits of short-term use of KI to block uptake of radioactive iodine by the thyroid gland far exceed its chances of side effects.

    Patients with thyroid disease: If you have both a nodular thyroid condition such as multinodular goiter with heart disease, you should not take KI. Patients with other thyroid conditions may take KI as directed above, but call a doctor if you need to take KI for more than a few days.


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

How Supplied



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).

IOSAT™ (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: 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.


Storage And Handling



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


Principal Display Panel



IOSAT™ (Potassium Iodide Tablets, USP 65 mg)


* Please review the disclaimer below.