47762f8f-30e2-445d-aaa1-e04479f8dd5b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
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).
Medication Information
Recent Major Changes
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 EFFECTSbelow).
Warnings and Precautions
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.
Indications and Usage
DIRECTIONS FOR USE
Use only as directed by public officials if a nuclear radiation emergency happens.
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 one65 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 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 child’s age as described in the following table:
| Child’s 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 onesingle dose in teaspoons (nottablespoons). You should give your child onedose 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.
Description
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).
Section 42229-5
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 a 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.
Section 50565-1
Carton Label - Principal Display Panel
NDC-50633-910-20
ThyroSafe
®
Potassium Iodide Tablets, USP, 65 mg
Thyroid blocking in a radiation emergency only
20 tablets, 65 milligrams each
Carton Label – Back panel
Potassium Iodide (KI) Tablets USP, 65 mg
| Drug Facts | |
|
Active Ingredient (in each tablet)
Potassium Iodide 65 mg |
Purpose
Thyroid blocking |
| Usehelps 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:
|
|
Do not useif you have
|
|
Stop use and ask a doctor if you haveif you have
|
|
| Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. | |
Directions
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. |
|
| 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 |
| babies at birth to 1 month | 16.25 mg daily as directed in 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 |
Section 51727-6
Inactive ingredients
lactose, magnesium stearate, microcrystalline cellulose
Questions or comments?
call toll free 1-866-849-7672
Section 55105-1
INDICATIONS
ThyroSafe® (Potassium Iodide Tablets, USP) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.
Section 55106-9
DESCRIPTION
Each white, round, cross-scored ThyroSafe® tablet contains 65 mg of potassium iodide.
Principal Display Panel Pack Label
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.
Structured Label Content
Recent Major Changes (34066-1)
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 EFFECTSbelow).
Indications and Usage (34067-9)
DIRECTIONS FOR USE
Use only as directed by public officials if a nuclear radiation emergency happens.
Dosage and Administration (34068-7)
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 one65 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 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 child’s age as described in the following table:
| Child’s 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 onesingle dose in teaspoons (nottablespoons). You should give your child onedose 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.
Warnings and Precautions (34071-1)
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.
Section 42229-5 (42229-5)
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 a 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.
Section 50565-1 (50565-1)
Carton Label - Principal Display Panel
NDC-50633-910-20
ThyroSafe
®
Potassium Iodide Tablets, USP, 65 mg
Thyroid blocking in a radiation emergency only
20 tablets, 65 milligrams each
Carton Label – Back panel
Potassium Iodide (KI) Tablets USP, 65 mg
| Drug Facts | |
|
Active Ingredient (in each tablet)
Potassium Iodide 65 mg |
Purpose
Thyroid blocking |
| Usehelps 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:
|
|
Do not useif you have
|
|
Stop use and ask a doctor if you haveif you have
|
|
| Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. | |
Directions
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. |
|
| 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 |
| babies at birth to 1 month | 16.25 mg daily as directed in 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 |
Section 51727-6 (51727-6)
Inactive ingredients
lactose, magnesium stearate, microcrystalline cellulose
Questions or comments?
call toll free 1-866-849-7672
Section 55105-1 (55105-1)
INDICATIONS
ThyroSafe® (Potassium Iodide Tablets, USP) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.
Section 55106-9 (55106-9)
DESCRIPTION
Each white, round, cross-scored ThyroSafe® tablet contains 65 mg of potassium iodide.
Principal Display Panel Pack Label (Principal Display Panel - Pack Label)
Principal Display Panel 65 Mg Carton Label (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.
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Raw Label Data
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Source: dailymed · Ingested: 2026-02-15T12:00:10.416581 · Updated: 2026-03-14T23:11:33.591824