Iosat

Potassium Iodide

Anbex Inc.
Human Otc Drug
NDC 51803-002

Iosat also known as Potassium Iodide is a human otc drug labeled by 'Anbex Inc.'. National Drug Code (NDC) number for Iosat is 51803-002. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Iosat drug includes Potassium Iodide - 65 mg/1 . The currest status of Iosat drug is Active.

Drug Information:

Drug NDC:	51803-002
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Iosat
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Potassium Iodide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Anbex Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	POTASSIUM IODIDE - 65 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	01 May, 2013
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	07 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	NDA018664
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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Anbex Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	430174 1423814
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	1C4QK22F9J
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
51803-002-01	20 TABLET in 1 PACKAGE (51803-002-01)	01 May, 2013	N/A	No
51803-002-02	14 TABLET in 1 PACKAGE (51803-002-02)	23 Nov, 2015	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Kali Iodatum 1x

Potassium Iodide

Liquid
Natural Creations, Inc.
NDC: 43406-0094

Thyrosafe

Potassium Iodide

Tablet
BTG International Inc.
NDC: 50633-910

Iosat

Potassium Iodide

Tablet
Anbex Inc.
NDC: 51803-002

Kali Iodatum

Potassium Iodide

Pellet
Washington Homeopathic Products
NDC: 68428-453

Potassium Iodide

Solution
Mission Pharmacal Company
NDC: 0178-0314

Iosat

Potassium Iodide

Tablet
Anbex Inc.
NDC: 51803-001

Purpose:

Purpose thyroid blocking

Product Elements:

Iosat potassium iodide cellulose, microcrystalline magnesium stearate silicon dioxide sodium thiosulfate anhydrous potassium iodide iodide ion iosat

Indications and 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 iosatâ¢ (potassium iodide tablets, usp) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.

Warnings:

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.

e 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 âholdâ 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

Do Not Use:

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 âstoreâ 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 âholdâ 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

Dosage and 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 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, breastfeedi Read more...

ng, 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.

Stop Use:

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:

Description each white, round, cross-scoredâthe name iosat stamped on one sideâtablet contains 65 mg of potassium iodide.

How Supplied:

How supplied iosatâ¢ (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). iosatâ¢ (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: iosatâ¢ (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.

Spl Patient Package Insert:

Consumer package insert iosatâ¢ (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).

Package Label Principal Display Panel:

Principal display panel iosatâ¢ (potassium iodide tablets, usp 65 mg) iosat 65 package label

Further Questions:

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

Comments/ Reviews:

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