ThyroShield

Name: ThyroShield

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Manufacturer

  • Fleming & Company, Pharmaceuticals

  • Fleming Pharmaceuticals

What is the most important information I should know about ThyroShield (potassium iodide)?

Potassium iodide is used to thin mucus and loosen congestion in people with chronic breathing problems that can be complicated by thick mucus in the respiratory tract.

Potassium iodide can cause thyroid problems, high potassium levels in your blood, or iodide poisoning. Call your doctor at once if you have swelling in your neck or throat, chest pain, irregular heart rate, muscle weakness, tingly feeling, pain or burning in your mouth, severe headache, or eye irritation.

What should I avoid while taking ThyroShield (potassium iodide)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

ThyroShield (potassium iodide) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives, itching, severe tingling; fever, swollen glands, joint pain; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • swelling in your neck or throat (enlarged thyroid);

  • chest pain, rapid or irregular heart rate, feeling anxious or irritable;

  • severe headache, metallic taste in your mouth;

  • puffy eyelids, irritated eyes, acne or severe skin rash;

  • pain or burning in your mouth or throat, increased salivation;

  • fever, cold symptoms (stuffy nose, sneezing, sore throat);

  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).

Common side effects may include:

  • swollen glands in your lower jaw;

  • nausea, vomiting, diarrhea, upset stomach, or stomach pain;

  • confusion, tired feeling, numbness;

  • mild skin rash; or

  • weakness or heavy feeling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Proper Use of potassium iodide

This section provides information on the proper use of a number of products that contain potassium iodide. It may not be specific to ThyroShield. Please read with care.

If potassium iodide upsets your stomach, take it after meals or with food or milk unless otherwise directed by your doctor. If stomach upset (nausea, vomiting, stomach pain, or diarrhea) continues, check with your doctor.

For patients taking this medicine for radiation exposure :

  • Take this medicine only when directed to do so by state or local public health authorities.
  • Take this medicine once daily until the risk of significant exposure to radiation no longer exists.Do not take more of it and do not take it more often than directed. Taking more of the medicine will not protect you better and may result in a greater chance of side effects.

For patients taking the oral solution form of this medicine:

  • This medicine is to be taken by mouth even if it comes in a dropper bottle.
  • Do not use if solution turns brownish yellow.
  • Take potassium iodide in a full glass (8 ounces) of water or in fruit juice, milk, or broth to improve the taste and lessen stomach upset. Be sure to drink all of the liquid to get the full dose of medicine.
  • If crystals form in potassium iodide solution, they may be dissolved by warming the closed container of solution in warm water and then gently shaking the container.

For patients taking the uncoated tablet form of this medicine:

  • Before taking, dissolve each tablet in ½ glass (4 ounces) of water or milk. Be sure to drink all of the liquid to get the full dose of medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For solution dosage form:
    • To treat overactive thyroid (hyperthyroidism):
      • Adults and teenagers—250 milligrams (mg) (0.25 milliliters [mL]) three times a day.
      • Children—Use and dose must be determined by your doctor.
    • To protect the thyroid gland against radiation exposure:
      • Adults or teenagers approaching adult weight (greater than 70 kg or 154 lbs of body weight)—130 mg once a day, until significant risk of exposure to radioiodines no longer exists.
      • Children through 1 month of age—16 mg once a day, until significant risk of exposure to radioiodines no longer exists.
      • Children over 1 month through 3 years of age—32 mg once a day, until significant risk of exposure to radioiodines no longer exists.
      • Children and teenagers over 3 years through 18 years of age (less than 70 kg or 154 lbs of body weight) —65 mg once a day, until significant risk of exposure to radioiodines no longer exists.
  • For syrup dosage form:
    • To protect the thyroid gland against radiation exposure:
      • Adults or teenagers approaching adult weight (70 kg or 154 lbs of body weight) greater)—130 mg once a day, until significant risk of exposure to radioiodines no longer exists.
      • Children through 1 month of age—16 mg once a day, until significant risk of exposure to radioiodines no longer exists.
      • Children over 1 month through 3 years of age—32 mg once a day, until significant risk of exposure to radioiodines no longer exists.
      • Children and teenagers over 3 years through 18 years of age (less than 70 kg or 154 lbs of body weight)—65 mg once a day, until significant risk of exposure to radioiodines no longer exists.
  • For tablet dosage form:
    • To protect the thyroid gland against radiation exposure:
      • Adults or teenagers approaching adult weight (70 kg or 154 lbs of body weight)—130 mg once a day, until significant risk of exposure to radioiodines no longer exists.
      • Children through 1 month of age—16 mg once a day, until significant risk of exposure to radioiodines no longer exists.
      • Children over 1 month through 3 years of age—32 mg once a day, until significant risk of exposure to radioiodines no longer exists.
      • Children and teenagers over 3 years through 18 years of age (less than 70 kg or 154 lbs of body weight)—65 mg once a day, until significant risk of exposure to radioiodines no longer exists.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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.

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.

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.


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)

  • 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.

Principal Display Panel - bottle

Thyroshield 
potassium iodide solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0256-0210
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM IODIDE (IODIDE I-125) POTASSIUM IODIDE 65 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40  
FD&C BLUE NO. 1  
METHYLPARABEN  
PROPYLENE GLYCOL  
PROPYLPARABEN  
WATER  
SUCROSE  
SACCHARIN SODIUM  
Product Characteristics
Color PURPLE Score     
Shape Size
Flavor RASPBERRY (Black) Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:0256-0210-01 1 BOTTLE, DROPPER (BOTTLE) in 1 CARTON
1 30 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077218 04/01/2005
Labeler - Fleming & Company, Pharmaceuticals (006491351)
Revised: 12/2009   Fleming & Company, Pharmaceuticals
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