ThyroShield Potassium Iodide POTASSIUM IODIDE IODIDE ION FD&C RED NO. 40 FD&C BLUE NO. 1 METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SUCROSE SACCHARIN SODIUM Black

Warnings Allergy alert: Iodine may cause an allergic reaction with 1 or more of the following symptoms: • shortness of breath or wheezing • skin rash • trouble breathing, speaking or swallowing • swelling • 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 • an 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. 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. HOW POTASSIUM IODIDE WORKS: Certain 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 a 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. WHO SHOULD NOT TAKE POTASSIUM IODIDE: People should avoid KI if they are allergic to iodine, have dermatitis herpetiformis or hypocomplementemic vasculitis, or have nodular thyroid disease with heart disease, because these conditions may increase the chances of side effects to iodine. HOW AND WHEN TO TAKE POTASSIUM IODIDE: KI should be taken as soon as possible after public officials tell you. If you are told to repeat the dose, you should take the second dose 24 hours after the first dose. Do not take it sooner. More KI will not help you because the thyroid can “hold” only certain amounts of iodine. Taking more than 1 dose per day will increase the chances of side effects. The public officials will tell you how many days to take KI. You should take KI until the chances of major exposure to radioactive iodine by breathing or swallowing stops. SIDE EFFECTS: Short-term use of KI at the recommended dose is safe. You should not take this drug for longer than you are told. Possible side effects include: swelling of the salivary glands, nausea, vomiting, diarrhea, stomach ache, fever, headache, metallic taste, and allergic reactions. Allergic reaction can include • skin rashes such as hives • swelling of various parts of the body such as the face, lips, tongue, throat, hands or feet • fever with joint pain • trouble breathing, speaking or swallowing • wheezing or shortness of breath Get medical attention right away if you have trouble breathing, speaking or swallowing; wheezing; shortness of breath; or swelling of the mouth, tongue or throat. Taking iodide, in rare cases, may cause overactivity of the thyroid gland, underactivity of the thyroid gland, or enlargement of the thyroid gland (goiter). Symptoms of an overactive thyroid gland may include an irregular heart beat and chest pain. Patients with thyroid disease are more likely to get these side effects. Babies under 1 month of age are more likely to get an underactive thyroid gland (hypothyroidism). WHAT TO DO IF SIDE EFFECTS OCCUR: Stop taking KI and call a doctor if you have one or more of the following symptoms: • swelling of the face, hands or feet • fever and joint pain • skin rash Stop taking KI and get medical help right away if you have one or more of the following symptoms: • trouble breathing, speaking or swallowing • shortness of breath or wheezing • swelling of the lips, tongue or throat • irregular heart beat or chest pain You may report side effects to FDA at 1-800-FDA-1088