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| Product NDC Code | 0178-0314 | ||||
|---|---|---|---|---|---|
| Drug Name | Potassium iodide |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 242429 | ||||
| Application Number | ANDA206211 | ||||
| Labeler Name | Mission Pharmacal Company | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Potassium iodide (USP) 65 mg
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION: 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.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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) Dropper 2mL Dropper 1mL Dropper 0.5mL Dropper 0.25 mL
DIRECTIONS FOR USE: 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) who weigh at least 150 pounds 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. Dropper 2mL Dropper 1mL Dropper 0.5mL Dropper 0.25mL
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
INDICATIONS: Potassium Iodide Oral Solution is a thyroid blocking medicine that is used in a nuclear radiation emergency only.
Purpose
Information about the drug product’s indications for use.Purpose Thyroid blocking
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 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.
Spl product data elements
Usually a list of ingredients in a drug product.POTASSIUM IODIDE POTASSIUM IODIDE FD&C RED NO. 40 FD&C BLUE NO. 1 METHYLPARABEN BLACK RASPBERRY PROPYLENE GLYCOL PROPYLPARABEN WATER SUCROSE SACCHARIN SODIUM POTASSIUM IODIDE IODIDE ION Black
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel - carton carton-label
Principal Display Panel - bottle container-label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Consumer Package Insert POTASSIUM IODIDE ORAL SOLUTION (Potassium Iodide Oral Solution, 1 mL = 65 mg) (Abbreviated KI)
Take potassium iodide (KI) only when public officials tell you. In a 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 one 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).
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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).
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep Out of Reach of Children. In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? call toll free 1-800-531-3333
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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.
Pregnant or breastfeeding women, or babies under 1 month of age: Take as directed above and call a doctor as soon as possible. Repeat dosing should be avoided. It is recommended that thyroid function be checked in babies less than 1 month of age that take KI. Women who are pregnant or breastfeeding should also be checked by a 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 a 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 a doctor if you need to take KI for more than a few days.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.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
HOW SUPPLIED: 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
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API