ThyroSafe

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Potassium Iodide 65 mg

Purpose

OTC - PURPOSE SECTION

Thyroid blocking

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

SPL UNCLASSIFIED 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

OTC - DO NOT USE SECTION

Do not use if you have

• ever had an allergic reaction to iodine
• nodular thyroid disease with heart disease
• hypocomplementemic vasculitis
• dermatitis herpetiformis

OTC - STOP USE SECTION

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 of 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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 like cola, or raspberry syrup. 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) daily (32.5 mg)
babies at birth to 1 month	16.25 mg daily as directed in consumer package insert

OTC - PREGNANCY OR BREAST FEEDING SECTION

• 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

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

lactose, magnesium stearate, microcrystalline cellulose

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-866-849-7672

Principal Display Panel - 65 mg Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC-66983-350-20

ThyroSafe^®

Potassium Iodide Tablets, USP, 65 mg

Thyroid blocking in a radiation emergency only

20 tablets, 65 milligrams each

Recipharm

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

• ThyroSafe
• Potassium Iodide
• Iodide Ion
• Lactose, Unspecified form
• Microcrystalline Cellulose
• Magnesium Stearate

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

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Observed Orange Book product history#

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Product history page 1 of 2 · 51 observed states.

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