THYROSAFE

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

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.

INDICATIONS ThyroSafe® (Potassium Iodide Tablets, USP) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.

Carton Label - Principal Display Panel NDC-50633-910-20 ThyroSafe ® Potassium Iodide Tablets, USP, 65 mg Thyroid blocking in a radiation emergency only 20 tablets, 65 milligrams each Carton Label – Back panel Potassium Iodide (KI) Tablets USP, 65 mg Drug Facts Active Ingredient (in each tablet) Potassium Iodide 65 mg Purpose Thyroid blocking 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 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 Do not use if you have ever had an allergic reaction to iodine nodular thyroid disease with heart disease hypocomplementemic vasculitis dermatitis herpetiformis Stop use and ask a doctor if you have 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. 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) 32.5 mg daily as directed in the consumer package insert babies at birth to 1 month 16.25 mg daily as directed in consumer package insert 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