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ThyroSafe
Potassium Iodide · Tablet
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryRegulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 076350-001 | THYROSAFE | TABLET | POTASSIUM IODIDE | Over-the-counter | — | RS | |
| 076350-002 | THYROSAFE | TABLET | POTASSIUM IODIDE | Over-the-counter | — |
Therapeutic equivalence
Source: Orange BookCodes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 4 | Labeling | Approved | February 13, 2004 | — |
| Supplement | 2 | Labeling | Approved | May 21, 2003 | — |
| Supplement | 1 | Labeling | Approved | April 30, 2003 | — |
| Original application | 1 | Approved | September 10, 2002 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260819). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingDIRECTIONS FOR USE Use only as directed by public officials if a nuclear radiation emergency happens.
Purpose
openFDA Drug LabelingINDICATIONS ThyroSafe ® (Potassium Iodide Tablets, USP, 130 mg) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.
Dosage and Administration
openFDA Drug LabelingDose: Adults over 18 years 1 tablet (whole or crushed) every day (130 mg) Children over 12 years to 18 years who weigh at least 150 pounds 1 tablet (whole or crushed) every day (130 mg) Children over 12 years to 18 years who weigh less than 150 pounds 1/2 tablet (whole or crushed) or 4 teaspoonfuls every day (65 mg) Children over 3 years to 12 years 1/2 tablet (whole or crushed) or 4 teaspoonfuls every day (65 mg) Children over 1 month 2 teaspoonfuls every day (32.5 mg) Babies at birth to 1 month 1 teaspoonful 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. More will not help you. Too much medicine may increase the chances of side effects. Making a Potassium Iodide Liquid Mixture: 1. Put one 130 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. 2. Add 4 teaspoonfuls of water to the crushed KI powder in the bowl and mix until the KI powder is dissolved in the water. 3. 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. 4. 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 (130 mg tablet) in the drink when mixed as described above is 16.25 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 Age Give your child this amount in teaspoonfuls Over 12 to 18 years old who weigh less than 150 pounds 4 teaspoonfuls will give you a 65 mg dose Over 3 to 12 years old 4 teaspoonfuls will give you a 65 mg dose Over 1 month to 3 years old 2 teaspoonfuls will give you a 32.5 mg dose Birth to 1 month 1 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.
Warnings
openFDA Drug LabelingWARNING 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.
Active Ingredient
openFDA Drug LabelingDESCRIPTION Each white, round, with a cross line on both sides ThyroSafe ® tablet contains 130 mg of potassium iodide.
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: POTASSIUM IODIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50633-920-20 | 50633-920 | BTG International Inc | 420 BOX in 1 CARTON (50633-920-20) / 20 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK | November 26, 2025 |
| 50633-910-20 | 50633-910 | BTG International Inc. | 160 BOX in 1 CARTON (50633-910-20) / 20 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK | September 30, 2002 |
| 50633-920 | 50633-920 | BTG International Inc | — | November 26, 2025 |
| 50633-910 | 50633-910 | BTG International Inc. | — | September 30, 2002 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.