OTC - QUESTIONS SECTION.


Questions or Commentscalltoll free 1-800-531-3333.

DESCRIPTION SECTION.


DESCRIPTION:. Each milliliter (1 mL) of Potassium Iodide Oral Solution contains65 mg of potassium iodide (USP) in black raspberry-flavored solution.Inactive ingredients are: FD&C Red 40 and Blue 1, methylparaben,natural and artificial black raspberry flavor, propylene glycol, propylparaben,purified water (USP), sodium saccharin, sucrose.

DOSAGE & ADMINISTRATION SECTION.


Directionsuse as directed by public officials in the event of nuclearradiation emergency. do not take more than dose in 24 hours. Dosing Chart (dropper inside) Adults over 18 years2 mL every day (130 mg) and Children over 12 years to 18 years who weigh at least 150 pounds mL every day (130mg) Children over 12 years to 18 years who weigh less than 150 pounds mL every day(65 mg) and Children over years to 12years mL every day (65 mg) Children over month to years0.5 mL every day (32.5 mg) Babies at birth to month0.25 mL every day (16.25 mg) use as directed by public officials in the event of nuclearradiation emergency. do not take more than dose in 24 hours. Dropper 2mL. Dropper 1mL. Dropper 0.5mL. Dropper 0.25 mL.

HOW SUPPLIED SECTION.


Other Informationstore at 25C (77F). Excursions permitted to 15-30C (59-86F).See USP Controlled Room Temperature.keep container tightly closedkeep in carton protected from lightdo not throw away consumer package insert. store at 25C (77F). Excursions permitted to 15-30C (59-86F).See USP Controlled Room Temperature.. keep container tightly closed. keep in carton protected from light. do not throw away consumer package insert.

INACTIVE INGREDIENT SECTION.


Inactive ingredientsFD&C Red 40 and Blue 1, methylparaben, naturaland artificial black raspberry flavor, propylene glycol, propylparaben,purified water (USP), sodium saccharin, sucrose.

INDICATIONS & USAGE SECTION.


UsesHelps prevent radioactiveiodine from getting into the thyroid gland during nuclear radiationemergency. Use along with other emergency measures recommended bypublic officials.

OTC - ACTIVE INGREDIENT SECTION.


Active IngredientPotassium iodide (USP) 65 mg.

OTC - ASK DOCTOR SECTION.


WHAT TO DO IF SIDE EFFECTS OCCUR:. Stop taking KI and call doctor if you have one or moreof the following symptoms:swelling of the face, hands or feetfever and joint painskin rashStop taking KI and get medical help right away if you haveone or more of the following symptoms:trouble breathing, speaking or swallowingshortness of breath or wheezingswelling of the lips, tongue or throatirregular heart beat or chest pain. swelling of the face, hands or feet. fever and joint pain. skin rash. trouble breathing, speaking or swallowing. shortness of breath or wheezing. swelling of the lips, tongue or throat. irregular heart beat or chest pain.

OTC - DO NOT USE SECTION.


SIDE EFFECTS:. Short-term use of KI at the recommended dose is safe. You shouldnot take this drug for longer than you are told.Possible side effects include: swelling of the salivaryglands, nausea, vomiting, diarrhea, stomach ache, fever, headache,metallic taste, and allergic reactions. Allergic reaction can includeskin rashes such as hivesswelling of various parts of the body such as the face,lips, tongue, throat, hands or feetfever with joint paintrouble breathing, speaking or swallowingwheezing or shortness of breathGet medical attention right away ifyou have trouble breathing, speaking or swallowing; wheezing; shortnessof breath; or swelling of the mouth, tongue or throat.Taking iodide, in rare cases, may causeoveractivity of the thyroid gland, underactivity of the thyroid gland,or enlargement of the thyroid gland (goiter). Symptoms of an overactivethyroid gland may include an irregular heart beat and chest pain.Patients with thyroid disease are more likely to get these side effects.Babies under month of age are more likely to get an underactivethyroid gland (hypothyroidism).. 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep Out ofReach of Children.In case of overdose, get medical help or contact Poison ControlCenter right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION.


If pregnant,breastfeeding, have baby up to month of age or have thyroid disease(except nodular thyroid disease with heart disease), take asdirected and contact doctor as soon as possible.

OTC - PURPOSE SECTION.


PurposeThyroid blocking.

OTC - STOP USE SECTION.


WHO SHOULD NOT TAKE POTASSIUM IODIDE:. People should avoid KI if they are allergic toiodine, have dermatitis herpetiformis or hypocomplementemic vasculitis,or have nodular thyroid disease with heart disease, because theseconditions may increase the chances of side effects to iodine.

OTC - WHEN USING SECTION.


HOW AND WHEN TO TAKE POTASSIUM IODIDE:. KI should be taken as soon as possible afterpublic officials tell you. If you are told to repeat the dose, youshould take the second dose 24 hours after the first dose. Do nottake it sooner. More KI will not help you because the thyroid canhold only certain amounts of iodine. Taking more than dose perday will increase the chances of side effects. The public officialswill tell you how many days to take KI. You should take KI until thechances of major exposure to radioactive iodine by breathing or swallowingstops.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PrincipalDisplay Panel carton. carton-label.

SPL UNCLASSIFIED SECTION.


Consumer Package InsertPOTASSIUM IODIDE ORALSOLUTION(Potassium Iodide Oral Solution, mL =65 mg) (Abbreviated KI).

WARNINGS SECTION.


WarningsAllergy alert:Iodine may cause an allergic reaction with or more of the followingsymptoms: shortness of breath or wheezingskin rash trouble breathing, speaking or swallowingswellingfever and joint painDo 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 doctor if you have an allergic reaction. Get medical help right away if youhave 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. shortness of breath or wheezing. skin rash trouble breathing, speaking or swallowing. swelling. fever and joint pain. an allergic reaction to iodine nodular thyroid disease with heart disease hypocomplementemic vasculitis dermatitis herpetiformis an allergic reaction. Get medical help right away if youhave 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 ofReach of Children.In case of overdose, get medical help or contact Poison ControlCenter right away.