NDC 43857-0445 Metabolism

Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Rhamnus Purshiana, Trifolium Pratense, Xanthoxylum Fraxineum, Ascorbic Acid, Cyanocobalamin, Riboflavinum, Thiaminum Hydrochloricum, Germanium Sesquioxide, Cysteinum, Manganese Gluconate, Adenosinum Triphosphoricum Dinatrum, Alpha-ketoglutaricum Acidum, Fumaricum Acidum, Magnesia Phosphorica, Natrum Oxalaceticum, Pulsatilla (vulgaris), Pyruvic Acid, Ubidecarenonum, Hepar Sulphuris Calcareum

NDC Product Code 43857-0445

NDC Code: 43857-0445

Proprietary Name: Metabolism 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: Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Rhamnus Purshiana, Trifolium Pratense, Xanthoxylum Fraxineum, Ascorbic Acid, Cyanocobalamin, Riboflavinum, Thiaminum Hydrochloricum, Germanium Sesquioxide, Cysteinum, Manganese Gluconate, Adenosinum Triphosphoricum Dinatrum, Alpha-ketoglutaricum Acidum, Fumaricum Acidum, Magnesia Phosphorica, Natrum Oxalaceticum, Pulsatilla (vulgaris), Pyruvic Acid, Ubidecarenonum, Hepar Sulphuris Calcareum 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.

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc.
    • 43857-0445 - Metabolism

NDC 43857-0445-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Metabolism with NDC 43857-0445 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Metabolism is berberis vulgaris, glycyrrhiza glabra, lappa major, rhamnus purshiana, trifolium pratense, xanthoxylum fraxineum, ascorbic acid, cyanocobalamin, riboflavinum, thiaminum hydrochloricum, germanium sesquioxide, cysteinum, manganese gluconate, adenosinum triphosphoricum dinatrum, alpha-ketoglutaricum acidum, fumaricum acidum, magnesia phosphorica, natrum oxalaceticum, pulsatilla (vulgaris), pyruvic acid, ubidecarenonum, hepar sulphuris calcareum. 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.

Metabolism 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.

  • BERBERIS VULGARIS ROOT BARK 3 [hp_X]/mL
  • GLYCYRRHIZA GLABRA 3 [hp_X]/mL
  • ARCTIUM LAPPA ROOT 3 [hp_X]/mL
  • FRANGULA PURSHIANA BARK 3 [hp_X]/mL
  • TRIFOLIUM PRATENSE FLOWER 3 [hp_X]/mL
  • ZANTHOXYLUM AMERICANUM BARK 3 [hp_X]/mL
  • ASCORBIC ACID 6 [hp_X]/mL
  • CYANOCOBALAMIN 6 [hp_X]/mL
  • RIBOFLAVIN 6 [hp_X]/mL
  • THIAMINE HYDROCHLORIDE 6 [hp_X]/mL
  • GERMANIUM SESQUIOXIDE 8 [hp_X]/mL
  • CYSTEINE 9 [hp_X]/mL
  • MANGANESE GLUCONATE 10 [hp_X]/mL
  • ADENOSINE TRIPHOSPHATE DISODIUM 12 [hp_X]/mL
  • .ALPHA.-KETOGLUTARIC ACID 12 [hp_X]/mL
  • FUMARIC ACID 12 [hp_X]/mL
  • MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X]/mL
  • SODIUM DIETHYL OXALACETATE 12 [hp_X]/mL
  • PULSATILLA VULGARIS 12 [hp_X]/mL
  • PYRUVIC ACID 12 [hp_X]/mL
  • UBIDECARENONE 12 [hp_X]/mL
  • CALCIUM SULFIDE 30 [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.

  • 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.

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: 05-18-2017 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: 12-31-2019 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.

Metabolism Product Label Images

Metabolism 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:

Berberis Vulgaris 3X, Glycyrrhiza Glabra 3X, Lappa Major 3X, Rhamnus Purshiana 3X, Trifolium Pratense 3X, Xanthoxylum Fraxineum 3X, Ascorbic Acid 6X, Cyanocobalamin 6X, Riboflavinum 6X, Thiaminum Hydrochloricum 6X, Germanium Sesquioxide 8X, Cysteinum 9X, Manganese Gluconate 10X, Adenosinum Triphosphoricum Dinatrum 12X, alpha-Ketoglutaricum Acidum 12X, Fumaricum Acidum 12X, Magnesia Phosphorica 12X, Natrum Oxalaceticum 12X, Pulsatilla (Vulgaris) 12X, Pyruvic Acid 12X, Ubidecarenonum 12X, Hepar Sulphuris Calcareum 30X.

Indications:

For temporary relief of fatigue, exhaustion, and lowered metabolism.

For temporary relief of fatigue, exhaustion, and lowered metabolism.

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:

Demineralized Water, 25% Ethanol

Questions:

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

Package Display Label:

BIOActive NutritionalMETABOLISM1 FL OZ (30 ml)

* Please review the disclaimer below.

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