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ThyroSafe

Potassium Iodide · Tablet

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
ThyroSafe
Generic name
Potassium Iodide
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
BTG International Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Potassium Iodide 130 mg/1 312539 View
Potassium Iodide 65 mg/1 312539 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
4

Regulatory status

Source: Drugs@FDANDC Directory
Application number
076350
Application type
ANDA · Abbreviated New Drug Application
Approval date
September 10, 2002
Sponsor
BTG INTL
Products on application
2
Submissions recorded
4
Products approved under application 076350.
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 Book
TE code
—
Reference Listed Drug
No
Reference Standard
Yes

Codes 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
Most recent submissions on application 076350.
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 Labeling

Reproduced 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.

HUMAN OTC DRUG · 20260819

Indications and Usage

openFDA Drug Labeling

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

INDICATIONS 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 Labeling

Dose: 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.

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.

Active Ingredient

openFDA Drug Labeling

DESCRIPTION Each white, round, with a cross line on both sides ThyroSafe ® tablet contains 130 mg of potassium iodide.

Adverse event reports

Source: openFDA FAERS
2,100
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed 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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
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

Every dataset that contributed a fact to 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.