ThyroSafe

ThyroSafe is an FDA-registered drug product whose active ingredient is POTASSIUM IODIDE. It is labelled by BTG International Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 50633-910, application ANDA076350, label effective 20260826. It is one of 13 FDA drug label records sharing the active ingredient POTASSIUM IODIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing POTASSIUM IODIDE are most often described in connection with: only directed, public officials, nuclear radiation, emergency happens. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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 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.

FDA lists 13 drug label records with POTASSIUM IODIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is ThyroSafe used for?
DIRECTIONS FOR USE Use only as directed by public officials if a nuclear radiation emergency happens.

Who makes ThyroSafe?
BTG International Inc. is the labeler of record for ThyroSafe. 13 FDA label records share the active ingredient POTASSIUM IODIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does ThyroSafe come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is ThyroSafe prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing POTASSIUM IODIDE?
Yes. 13 FDA drug label records list POTASSIUM IODIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has ThyroSafe been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.