NDC 43857-0549 Thyro Tonic

Chelidonium Majus, Spongia Tosta, Lac Defloratum, Fucus Vesiculosus, Hepar Suis, Hypophysis Suis, Thyroidinum (suis), Calcarea Carbonica, Ferrum Iodatum, Iodium, Kali Iodatum, Molybdenum, Pulsatilla (pratensis)

NDC Product Code 43857-0549

NDC CODE: 43857-0549

Proprietary Name: Thyro Tonic What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Chelidonium Majus, Spongia Tosta, Lac Defloratum, Fucus Vesiculosus, Hepar Suis, Hypophysis Suis, Thyroidinum (suis), Calcarea Carbonica, Ferrum Iodatum, Iodium, Kali Iodatum, Molybdenum, Pulsatilla (pratensis) What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Potassium iodide is used to loosen and break up mucus in the airways. This helps you cough up the mucus so you can breathe more easily if you have long-term lung problems (e.g., asthma, chronic bronchitis, emphysema). This medication is known as an expectorant. Potassium iodide is also used along with antithyroid medicines to prepare the thyroid gland for surgical removal, to treat certain overactive thyroid conditions (hyperthyroidism), and to protect the thyroid in a radiation exposure emergency. It works by shrinking the size of the thyroid gland and decreasing the amount of thyroid hormones produced. In a radiation emergency, potassium iodide blocks only the thyroid from absorbing radioactive iodine, protecting it from damage and reducing the risk of thyroid cancer. Use this medication along with other emergency measures that will be recommended to you by public health and safety officials (e.g., finding safe shelter, evacuation, controlling food supply).

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc.

NDC 43857-0549-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Thyro Tonic with NDC 43857-0549 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Thyro Tonic is chelidonium majus, spongia tosta, lac defloratum, fucus vesiculosus, hepar suis, hypophysis suis, thyroidinum (suis), calcarea carbonica, ferrum iodatum, iodium, kali iodatum, molybdenum, pulsatilla (pratensis). The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritional, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Thyro Tonic Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CHELIDONIUM MAJUS 3 [hp_X]/mL
  • SPONGIA OFFICINALIS SKELETON, ROASTED 3 [hp_X]/mL
  • SKIM MILK 4 [hp_X]/mL
  • FUCUS VESICULOSUS 6 [hp_X]/mL
  • PORK LIVER 8 [hp_X]/mL
  • SUS SCROFA PITUITARY GLAND 8 [hp_X]/mL
  • THYROID, PORCINE 8 [hp_X]/mL
  • OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X]/mL
  • FERROUS IODIDE 12 [hp_X]/mL
  • IODINE 12 [hp_X]/mL
  • POTASSIUM IODIDE 12 [hp_X]/mL
  • MOLYBDENUM 12 [hp_X]/mL
  • ANEMONE PRATENSIS 12 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ACACIA (UNII: 5C5403N26O)
  • BORAGE OIL (UNII: F8XAG1755S)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • SESAME OIL (UNII: QX10HYY4QV)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bioactive Nutritional, Inc.
Labeler Code: 43857
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 02-26-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Thyro Tonic Product Label Images

Thyro Tonic Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients:

Chelidonium Majus 3X, Spongia Tosta 3X, Lac Defloratum 4X, 6X, 8X, Fucus Vesiculosus 6X, 12X, 30X, Hepar Suis 8X, Hypophysis Suis 8X, 12X, 100X, Thyroidinum (Suis) 8X, 12X, 100X, Calcarea Carbonica 12X, Ferrum Iodatum 12X, Iodium 12X, Kali Iodatum 12X, Molybdenum 12X, Pulsatilla (Pratensis) 12X.

Indications:

For temporary relief of tightening of the throat, hoarseness, joints inflamed and painful and dry cough in evening and at night.

For temporary relief of tightening of the throat, hoarseness, joints inflamed and painful and dry cough in evening and at night.

Warnings:

If pregnant or breast-feeding, ask a health care professional before use.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.Do not use if tamper evident seal is broken or missing.Store in a cool, dry place.

Keep Out Of Reach Of Children:

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

Directions:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Gum Arabic Tree (Acacia Senegal) Powder, Borage Oil, Olive Oil, Sesame Oil

Questions:

Distributed by:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935bioactivenutritional.com

Package Label Display:

BIOActive NutritionalTHYRO TONICHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.