Radiation Block

Manufacturer
EW Trading, Inc. DBA EW Packaging
Effective date
2024-03-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:07:31

Label at a glance#

ProductRadiation Block
Active ingredientPOTASSIUM IODIDE
Label structure12 sections

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 tak...

Label contents#

Full prescribing information#

Boxed Warning

BOXED WARNING SECTION

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).

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Each white, round, cross-scored Radiation Block tablet contains 65 mg of potassium iodide.

INDICATIONS

OTC - PURPOSE SECTION

Radiation Block (Potassium Iodide Tablets, USP) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.

Indications & Usage Section

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

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

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 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 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.

Warning

WARNINGS SECTION

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.

Other Information

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid, Magnesium Stearate, Dicalcium Phosphate Dihydrate

Dosage & Administration

RECENT MAJOR CHANGES SECTION

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 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 AgeGive 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.

Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Label - Principal Display Panel

NDC-60677-204

Radiation Block
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

Active ingredients (in each tablet) Potassium Iodide 65 mg

Purpose Thyroid blocking Use 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 one 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

  • allergic reaction. Get medical help right away if you have trouble breathing, speaking or swallowing; shortness or breath; wheezing; swelling of the mouth, tongue or throat; or rash.
  • irregular heart 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 or 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, raspberry syrup, or infant formula.

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 weight at least 150 pounds 2 tablets (whole or crushed) daily (130 mg)

children over 12 years to 18 years who weight 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 ½ tablet (whole or crushed) daily (32.5 mg)

babies at birth to 3 years ¼ tablet (whole or crushed) daily (16.25 mg)

Other information

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

Inactive ingredients

Microcrystalline Cellulose, Dicalcium Phosphate Dihydrate, Magnesium Stearate, Stearic Acid, Silicon Dioxide.

Questions or comments? Call weekdays from 8 a.m. to 4 p.m. PST at 1-310-515-9898

Distributed by: Earthnutri® 17510 S. Broadway St. Unit C Gardena, CA 90248 www.earthnutri.com

Radiation Block (Potassium Iodide Tablets, USP 65 mg)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 60677-240-01

Radiation Block

Potassium Iodide Tablets, USP, 65 mg

Thyroid blocking in a radiation emergency only

20 tablets, 65 milligrams each

Carton LabelCarton Label

Radiation Block (Potassium Iodide Tablets, USP 65 mg)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blister Foil LabelBlister Foil LabelPRINCIPAL DISPLAY PANEL - 65 MG BLISTER FOIL LABEL

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60677-24060677-240-01, 60677-240-02

Ingredients#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
14d298ba-8a1e-2095-e063-6294a90ad1b313f605fb-3712-8e87-e063-6394a90a93f22024-03-29Boxed warning, WarningsExact identifier
spl set id: 13f605fb-3712-8e87-e063-6394a90a93f2

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