NDC 43857-0553 Colotox

Alfalfa, Berberis Vulgaris, Rhamnus Purshiana, Rheum (palmatum), Taraxacum Officinale, Hepar Bovine, Small Intestine (suis), Aranea Diadema, Carbo Animalis, Carbo Vegetabilis, Cina, Mandragora Officinarum, Mercurius Solubilis, Selenium Metallicum, Spigelia Anthelmia, Veratrum Album, Bilirubin, Creatine, Creatinine, Indolum, Skatolum, Proteus (mirabilis), Morgan Gaertner

NDC Product Code 43857-0553

NDC CODE: 43857-0553

Proprietary Name: Colotox 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: Alfalfa, Berberis Vulgaris, Rhamnus Purshiana, Rheum (palmatum), Taraxacum Officinale, Hepar Bovine, Small Intestine (suis), Aranea Diadema, Carbo Animalis, Carbo Vegetabilis, Cina, Mandragora Officinarum, Mercurius Solubilis, Selenium Metallicum, Spigelia Anthelmia, Veratrum Album, Bilirubin, Creatine, Creatinine, Indolum, Skatolum, Proteus (mirabilis), Morgan Gaertner 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.

  • Drug uses not available
  • Drug uses not available

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc.

NDC 43857-0553-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Colotox with NDC 43857-0553 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Colotox is alfalfa, berberis vulgaris, rhamnus purshiana, rheum (palmatum), taraxacum officinale, hepar bovine, small intestine (suis), aranea diadema, carbo animalis, carbo vegetabilis, cina, mandragora officinarum, mercurius solubilis, selenium metallicum, spigelia anthelmia, veratrum album, bilirubin, creatine, creatinine, indolum, skatolum, proteus (mirabilis), morgan gaertner. 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.

Colotox 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.

  • MEDICAGO SATIVA WHOLE 3 [hp_X]/mL
  • BERBERIS VULGARIS ROOT BARK 3 [hp_X]/mL
  • FRANGULA PURSHIANA BARK 3 [hp_X]/mL
  • RHEUM PALMATUM ROOT 3 [hp_X]/mL
  • TARAXACUM OFFICINALE 3 [hp_X]/mL
  • BEEF LIVER 8 [hp_X]/mL
  • SUS SCROFA INTESTINAL MUCOSA 8 [hp_X]/mL
  • ARANEUS DIADEMATUS 12 [hp_X]/mL
  • CARBO ANIMALIS 12 [hp_X]/mL
  • ACTIVATED CHARCOAL 12 [hp_X]/mL
  • ARTEMISIA CINA PRE-FLOWERING TOP 12 [hp_X]/mL
  • MANDRAGORA OFFICINARUM ROOT 12 [hp_X]/mL
  • MERCURIUS SOLUBILIS 12 [hp_X]/mL
  • SELENIUM 12 [hp_X]/mL
  • SPIGELIA ANTHELMIA WHOLE 12 [hp_X]/mL
  • VERATRUM ALBUM ROOT 12 [hp_X]/mL
  • BILIRUBIN 15 [hp_X]/mL
  • CREATINE 15 [hp_X]/mL
  • CREATININE 15 [hp_X]/mL
  • INDOLE 15 [hp_X]/mL
  • SKATOLE 15 [hp_X]/mL
  • PROTEUS MIRABILIS 20 [hp_X]/mL
  • SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 12 [hp_C]/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.
  • 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: 03-23-2020 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.

Colotox Product Label Images

Colotox 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:

Alfalfa 3X, Berberis Vulgaris 3X, Rhamnus Purshiana 3X, Rheum (Palmatum) 3X, Taraxacum Officinale 3X, Hepar Bovine 8X, Small Intestine (Suis) 8X, Aranea Diadema 12X, Carbo Animalis 12X, Carbo Vegetabilis 12X, CINA 12X, Mandragora Officinarum 12X, Mercurius Solubilis 12X, Selenium Metallicum 12X, Spigelia Anthelmia 12X, Veratrum Album 12X, Bilirubin 15X, 30X, 200X, Creatine 15X, 30X, 200X, Creatinine 15X, 30X, 200X, Indolum 15X, 30X, 200X, Skatolum 15X, 30X, 200X, Proteus (Mirabilis) 20X, Morgan Gaertner 12C.

Indications:

For temporary relief of flatulence associated with constipation.

For temporary relief of flatulence associated with constipation.

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 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 Label Display:

BioActive NutritionalCOLOTOXHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.