Potassium Iodide
Mission Pharmacal Company
Human Otc Drug
NDC 0178-0314Potassium Iodide is a human otc drug labeled by 'Mission Pharmacal Company'. National Drug Code (NDC) number for Potassium Iodide is 0178-0314. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Potassium Iodide drug includes Potassium Iodide - 65 mg/mL . The currest status of Potassium Iodide drug is Active.
Drug Information:
| Drug NDC: | 0178-0314 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Potassium Iodide |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Potassium Iodide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Mission Pharmacal Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | POTASSIUM IODIDE - 65 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 15 May, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA206211 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Mission Pharmacal Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 242429
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 1C4QK22F9J
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0178-0314-30 | 1 BOTTLE, DROPPER in 1 CARTON (0178-0314-30) / 30 mL in 1 BOTTLE, DROPPER | 15 May, 2016 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
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 âstoreâ 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.
Product Elements:
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
Indications and Usage:
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.
Warnings:
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.
Do Not Use:
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.
When Using:
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 âholdâ 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.
Dosage and Administration:
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
Stop Use:
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.
Description:
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.
How Supplied:
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
Package Label Principal Display Panel:
Principal display panel - carton carton-label
Principal display panel - bottle container-label
Further Questions:
Questions or comments? call toll free 1-800-531-3333