OTC - PURPOSE SECTION.

INDICATIONSThyroSafe(R) (Potassium Iodide Tablets, USP) is thyroid blocking medicine that is used in nuclear radiation emergency only.

BOXED WARNING SECTION.

Take potassium iodide (KI) only when public officials tell you. In nuclear radiation emergency, radioactive iodine could be released into the air. KI protects only the thyroid gland from uptake of radioactive iodine. Therefore, KI should be used along with other emergency measures that will be recommended to you by public officials. If you are told to take this medicine, take it time every 24 hours. Do not take it more often. More KI will not help you. Too much KI may increase the chances of side effects. Do not take this medicine if you know you are allergic to iodine (see SIDE EFFECTS below).

DOSAGE & ADMINISTRATION SECTION.

Dose:Adults over 18 years2 tablets (whole or crushed) every day (130 mg)Children over 12 years to 18 years who weigh at least 150 pounds2 tablets (whole or crushed) every day (130 mg)Children over 12 years to 18 years who weigh less than 150 pounds1 tablet (whole or crushed) or teaspoons every day (65 mg)Children over years to 12 years1 tablet (whole or crushed) or teaspoons every day (65 mg)Children over month to years4 teaspoons every day (32.5 mg)Babies at birth to month2 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 Potassium Iodide Liquid Mixture.Take KI every day (every 24 hours) as directed by public officials. Do not take more than dose in 24 hours. More will not help you. Too much medicine may increase the chances of side effects.Making Potassium Iodide Liquid Mixture:Put one 65 mg KI tablet into small bowl and grind it into fine powder using the back of metal teaspoon against the inside of the bowl. The powder should not have any large pieces.Add 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 and mix it with 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 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 childs age as described in the following table:Childs AgeGive your child this amount in teaspoonsOver 12 to 18 years old who weigh less than 150 pounds8 teaspoons will give you 65 mg doseOver to 12 years old8 teaspoons will give you 65 mg doseOver month to years old4 teaspoons will give you 32.5 mg doseBirth to month2 teaspoons will give you 16.25 mg doseNote: 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 month of age: Take as directed above and call doctor as soon as possible. Repeat dosing should be avoided. It is recommended that thyroid function be checked in babies less than month of age that take KI. Women who are pregnant or breastfeeding should also be checked by 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 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 doctor if you need to take KI for more than few days.. Put one 65 mg KI tablet into small bowl and grind it into fine powder using the back of metal teaspoon against the inside of the bowl. The powder should not have any large pieces.. Add 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 and mix it with 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 days in the refrigerator. It is recommended that the KI liquid mixtures be prepared weekly. Throw away unused portions.

INACTIVE INGREDIENT SECTION.

Inactive ingredientslactose, magnesium stearate, microcrystalline celluloseQuestions or commentscall toll free 1-866-849-7672.

INDICATIONS & USAGE SECTION.

DIRECTION FOR USEUse only as directed by public officials if nuclear radiation emergency happens.

OTC - ACTIVE INGREDIENT SECTION.

DESCRIPTIONEach white, round, cross-scored ThyroSafe(R) tablet contains 65 mg of potassium iodide.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Carton Label Principal Display PanelNDC-50633-910-20ThyroSafe(R) Potassium Iodide Tablets, USP, 65 mg Thyroid blocking in radiation emergency only 20 tablets, 65 milligrams each Carton Label Back panelPotassium Iodide (KI) Tablets USP, 65 mgDrug FactsActive Ingredient (in each tablet)Potassium Iodide 65 mgPurposeThyroid blocking Use helps prevent radioactive iodine from getting into the thyroid gland during nuclear radiation emergency. Use along with other emergency measures recommended by public officials.WarningsAllergy alert: Iodine may cause an allergic reaction with or more of the following symptoms: shortness of breath or wheezing swellingskin rash trouble breathing, speaking or swallowingfever and joint pain Do not use if you have ever had an allergic reaction to iodinenodular thyroid disease with heart disease hypocomplementemic vasculitis dermatitis herpetiformisStop use and ask 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 Poison Control Center right away. Directionsuse as directed by public officials in the event of nuclear radiation emergency.do not take more than 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 liquid mixture. adults over 18 years2 tablets (whole or crushed) daily (130 mg)children over 12 years to 18 years who weigh at least 150 pounds2 tablets (whole or crushed) daily (130 mg)children over 12 years to 18 years who weigh less than 150 pounds1 tablet (whole or crushed) daily (65 mg)children over years to 12 years1 tablet (whole or crushed) daily (65 mg)children over month to years1/2 tablet (crushed) daily (32.5 mg)babies at birth to month16.25 mg daily as directed in consumer package insertIf pregnant, breastfeeding, have baby up to month of age, or have thyroid disease (except nodular thyroid disease with heart disease), take as directed above and contact doctor as soon as possible. shortness of breath or wheezing swelling. skin rash trouble breathing, speaking or swallowing. fever and joint pain ever had an allergic reaction to iodine. nodular thyroid disease with heart disease hypocomplementemic vasculitis dermatitis herpetiformis. 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.. use as directed by public officials in the event of nuclear radiation emergency.. do not take more than 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 liquid mixture.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Principal Display Panel 65 mg Carton Label NDC-50633-910-20ThyroSafe(R) Potassium Iodide Tablets, USP, 65 mgThyroid blocking in radiation emergency only 20 tablets, 65 milligrams eachBTG International Inc. Principal Display Panel 65 mg Carton Label.

SPL UNCLASSIFIED SECTION.

HOW POTASSIUM IODIDE WORKSCertain forms of iodine help your thyroid gland work right. Most people get the iodine they need from foods like iodized salt or fish. The thyroid can store or hold only certain amount of iodine.In nuclear radiation emergency, radioactive iodine may be released in the air. This material may be breathed or swallowed. It may enter the thyroid gland and damage it. The damage would probably not show itself for years. Children are most likely to have thyroid damage.If you take KI, it will block or reduce the chances that radioactive iodine will enter your thyroid gland.

WARNINGS SECTION.

WARNINGPeople 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 Poison Control Center right away.