NDC 43857-0414 Tobaccotox

Avena Sativa, Kali Phosphoricum, Cactus Grandiflorus, Daphne Indica, Eucalyptol, Lobelia Inflata, Mentholum, Ignatia Amara, Nux Vomica, Staphysagria, Tabacum, Benzinum, Naphthalinum

NDC Product Code 43857-0414

NDC Code: 43857-0414

Proprietary Name: Tobaccotox 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: Avena Sativa, Kali Phosphoricum, Cactus Grandiflorus, Daphne Indica, Eucalyptol, Lobelia Inflata, Mentholum, Ignatia Amara, Nux Vomica, Staphysagria, Tabacum, Benzinum, Naphthalinum 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.
    • 43857-0414 - Tobaccotox

NDC 43857-0414-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Tobaccotox with NDC 43857-0414 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Tobaccotox is avena sativa, kali phosphoricum, cactus grandiflorus, daphne indica, eucalyptol, lobelia inflata, mentholum, ignatia amara, nux vomica, staphysagria, tabacum, benzinum, naphthalinum. 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.

Tobaccotox 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.

  • AVENA SATIVA FLOWERING TOP 1 [hp_X]/mL
  • DIBASIC POTASSIUM PHOSPHATE 2 [hp_X]/mL
  • SELENICEREUS GRANDIFLORUS STEM 3 [hp_X]/mL
  • DAPHNE ODORA BARK 3 [hp_X]/mL
  • EUCALYPTOL 3 [hp_X]/mL
  • LOBELIA INFLATA 3 [hp_X]/mL
  • MENTHOL, UNSPECIFIED FORM 4 [hp_X]/mL
  • STRYCHNOS IGNATII SEED 12 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/mL
  • DELPHINIUM STAPHISAGRIA SEED 12 [hp_X]/mL
  • TOBACCO LEAF 12 [hp_X]/mL
  • BENZENE 15 [hp_X]/mL
  • NAPHTHALENE 15 [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: 08-26-2016 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.

Tobaccotox Product Label Images

Tobaccotox 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:

Avena Sativa 1X, Kali Phosphoricum 2X, Cactus Grandiflorus 3X, Daphne Indica 3X, Eucalyptol 3X, Lobelia Inflata 3X, Mentholum 4X, Ignatia Amara 12X, Nux Vomica 12X, Staphysagria 12X, Tabacum 12X, Benzinum 15X, 30X, Naphthalinum 15X, 30X

Indications:

For temporary relief of nausea with headache, dry cough, and constriction of the chest.

For temporary relief of nausea with headache, dry cough, and constriction of the chest.

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 NutritionalTOBACCOTOXHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.

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