Thyrosafe
FDA Label NDC 66983-350

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Recipharm Ab (publ) for the product Thyrosafe (NDC 66983-350). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, indications & usage, otc - do not use, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient (in Each Tablet)

→ Purpose

→ Indications & Usage

→ Otc - Do Not Use

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Otc - Pregnancy Or Breast Feeding

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 65 Mg Carton Label

Other

Drug Facts

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

Active Ingredient (In Each Tablet)

Potassium Iodide 65 mg

Purpose

Thyroid blocking

Indications & Usage

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.

Otc - Do Not Use

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

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

Keep out of reach of children. In case of 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 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

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