Thyrosafe
Potassium Iodide
Btg International Inc.
Human Otc Drug
NDC 50633-910Thyrosafe also known as Potassium Iodide is a human otc drug labeled by 'Btg International Inc.'. National Drug Code (NDC) number for Thyrosafe is 50633-910. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Thyrosafe drug includes Potassium Iodide - 65 mg/1 . The currest status of Thyrosafe drug is Active.
Drug Information:
| Drug NDC: | 50633-910 |
| 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: | Thyrosafe |
| 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: | Btg International 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: | ANDA |
| 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: | 30 Sep, 2002 |
| 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: | ANDA076350 |
| 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: | BTG International Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 430174
1086474
|
| 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 |
|---|
| 50633-910-20 | 160 BOX in 1 CARTON (50633-910-20) / 20 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK | 30 Sep, 2002 | 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. |
Purpose:
Indications thyrosafe® (potassium iodide tablets, usp) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.
Product Elements:
Thyrosafe potassium iodide potassium iodide iodide ion lactose, unspecified form microcrystalline cellulose magnesium stearate white round
Boxed Warning:
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).
Indications and Usage:
Direction for use use only as directed by public officials if a nuclear radiation emergency happens.
Warnings:
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.
Dosage and Administration:
Dose: 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 pounds 2 tablets (whole or crushed) every day (130 mg) children over 12 years to 18 years who weigh less than 150 pounds 1 tablet (whole or crushed) or 8 teaspoons every day (65 mg) children over 3 years to 12 years 1 tablet (whole or crushed) or 8 teaspoons every day (65 mg) children over 1 month to 3 years 4 teaspoons every day (32.5 mg) babies at birth to 1 month 2 teaspoons 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 po
Read more...wder using the back of a metal teaspoon against the inside of the bowl. the powder should not have any large pieces. add 4 teaspoons 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 teaspoons 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 mixtures 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 teaspoon. the number of teaspoons of the drink to give your child depends on your childâs age as described in the following table: childâs age give your child this amount in teaspoons over 12 to 18 years old who weigh less than 150 pounds 8 teaspoons will give you a 65 mg dose over 3 to 12 years old 8 teaspoons will give you a 65 mg dose over 1 month to 3 years old 4 teaspoons will give you a 32.5 mg dose birth to 1 month 2 teaspoons will give you a 16.25 mg dose note: this is the amount to give your child for one single dose in teaspoons (not tablespoons). 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.
Package Label Principal Display Panel:
Principal display panel - 65 mg carton label ndc-50633-910-20 thyrosafe ® potassium iodide tablets, usp, 65 mg thyroid blocking in a radiation emergency only 20 tablets, 65 milligrams each btg international inc. principal display panel - 65 mg carton label
Principal display panel - pack label principal display panel - 65 mg carton label