potassium iodide oral solution - potassium iodide oral solution

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.

Active Ingredient

Potassium iodide (USP) 65 mg

Uses

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.

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.

Dosing Chart

(dropper inside)

Adults over 18 years

2 mL every day (130 mg)

and

Children over 12 years to 18 years

who weigh at least 150 pounds

2 mL every day (130 mg)

Children over 12 years to 18 years

who weigh less than 150 pounds

1 mL every day (65 mg)

and

Children over 3 years to 12 years

1 mL every day (65 mg)

Children over 1 month to 3 years

0.5 mL every day (32.5 mg)

Babies at birth to 1 month

0.25 mL every day (16.25 mg)

Other Information

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

Consumer Package Insert

POTASSIUM IODIDE ORAL SOLUTION

(Potassium Iodide Oral Solution, 1 mL = 65 mg)

(Abbreviated KI)

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Inactive ingredients

FD&C Red #40 and Blue #1, methylparaben, natural and artificial black raspberry flavor, propylene glycol, propylparaben, purified water (USP), sodium saccharin, sucrose

Principal Display Panel - carton

Questions or Comments?

call toll free 1-800-531-3333

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 and contact a doctor as soon as possible.

Purpose

Thyroid blocking

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.

Each milliliter (1 mL) of Potassium Iodide Oral Solution contains 65 mg of potassium iodide (USP) in a 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.

Potassium Iodide Oral Solution is a thyroid blocking medicine that is used in a nuclear radiation emergency only.

Potassium Iodide Oral Solution is supplied in 1 oz (30 mL) bottles. Each mL contains 65 mg potassium iodide. Store at 25°C (77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Keep container tightly closed and in carton, protected from light.

MISSION PHARMACAL COMPANY

San Antonio, TX 78230 1355

PISP-001 C01 Rev 011120

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).

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

Dose:

Adults over 18 years 2 mL every day (130 mg)

Children over 12 years to 18 years 2 mL every day (130 mg)

Children over 12 years to 18 years 1 mL every day (65 mg)

who weigh less than 150 pounds

Children over 3 years to 12 years 1 mL every day (65 mg)

Children over 1 month to 3 years 0.5 mL every day (32.5 mg)

Babies at birth to 1 month 0.25 mL every day (16.25 mg)

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.

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

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 a 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.

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

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.

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.

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.

Active Ingredient

Potassium iodide (USP) 65 mg

Uses

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.

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.

Dosing Chart

(dropper inside)

Adults over 18 years

2 mL every day (130 mg)

and

Children over 12 years to 18 years

who weigh at least 150 pounds

2 mL every day (130 mg)

Children over 12 years to 18 years

who weigh less than 150 pounds

1 mL every day (65 mg)

and

Children over 3 years to 12 years

1 mL every day (65 mg)

Children over 1 month to 3 years

0.5 mL every day (32.5 mg)

Babies at birth to 1 month

0.25 mL every day (16.25 mg)

Other Information

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

Consumer Package Insert

POTASSIUM IODIDE ORAL SOLUTION

(Potassium Iodide Oral Solution, 1 mL = 65 mg)

(Abbreviated KI)

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Inactive ingredients

FD&C Red #40 and Blue #1, methylparaben, natural and artificial black raspberry flavor, propylene glycol, propylparaben, purified water (USP), sodium saccharin, sucrose

Principal Display Panel - carton

Questions or Comments?

call toll free 1-800-531-3333

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 and contact a doctor as soon as possible.

Purpose

Thyroid blocking

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.

Each milliliter (1 mL) of Potassium Iodide Oral Solution contains 65 mg of potassium iodide (USP) in a 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.

Potassium Iodide Oral Solution is a thyroid blocking medicine that is used in a nuclear radiation emergency only.

Potassium Iodide Oral Solution is supplied in 1 oz (30 mL) bottles. Each mL contains 65 mg potassium iodide. Store at 25°C (77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Keep container tightly closed and in carton, protected from light.

MISSION PHARMACAL COMPANY

San Antonio, TX 78230 1355

PISP-001 C01 Rev 011120

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).

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

Dose:

Adults over 18 years 2 mL every day (130 mg)

Children over 12 years to 18 years 2 mL every day (130 mg)

Children over 12 years to 18 years 1 mL every day (65 mg)

who weigh less than 150 pounds

Children over 3 years to 12 years 1 mL every day (65 mg)

Children over 1 month to 3 years 0.5 mL every day (32.5 mg)

Babies at birth to 1 month 0.25 mL every day (16.25 mg)

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.

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

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 a 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.

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

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.

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.