NDC 70034-001 Tabakfre

Equal Amounts Of Each Hpus Ingredient In 30c, 200c, 1m, Lm1, Lm2, Lm3, Lm4, And Lm5 Potencies

NDC Product Code 70034-001

NDC Code: 70034-001

Proprietary Name: Tabakfre 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: Equal Amounts Of Each Hpus Ingredient In 30c, 200c, 1m, Lm1, Lm2, Lm3, Lm4, And Lm5 Potencies 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

  • 70034 - Primal Earth Llc
    • 70034-001 - Tabakfre

NDC 70034-001-01

Package Description: 60 mL in 1 BOTTLE, DROPPER

NDC Product Information

Tabakfre with NDC 70034-001 is a a human over the counter drug product labeled by Primal Earth Llc. The generic name of Tabakfre is equal amounts of each hpus ingredient in 30c, 200c, 1m, lm1, lm2, lm3, lm4, and lm5 potencies. The product's dosage form is solution and is administered via oral form.

Labeler Name: Primal Earth Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Tabakfre 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.

  • ACONITUM NAPELLUS 30 [hp_C]/60mL
  • .ALPHA.-LIPOIC ACID, (+/-)- 30 [hp_C]/60mL
  • AGRIMONIA EUPATORIA FLOWER 30 [hp_C]/60mL
  • AMMONIA 30 [hp_C]/60mL
  • AMMONIUM CARBONATE 30 [hp_C]/60mL
  • ANTIMONY ARSENATE 30 [hp_C]/60mL
  • ANTIMONY POTASSIUM TARTRATE 30 1/60mL
  • ANTIMONY TRISULFIDE 30 1/60mL
  • ARABICA COFFEE BEAN 30 1/60mL
  • ARSENIC TRIIODIDE 30 1/60mL
  • ARSENIC TRIOXIDE 30 1/60mL
  • ASARUM EUROPAEUM 30 1/60mL
  • ASPIDOSPERMA QUEBRACHO-BLANCO BARK 30 1/60mL
  • ATROPA BELLADONNA 30 1/60mL
  • AVENA SATIVA FLOWERING TOP 30 1/60mL
  • BOS TAURUS HYPOTHALAMUS 30 1/60mL
  • BROMINE 30 1/60mL
  • CALCIUM IODIDE 30 1/60mL
  • CAPSICUM 30 1/60mL
  • CARBON DISULFIDE 30 1/60mL
  • CARBON MONOXIDE 30 1/60mL
  • CHELIDONIUM MAJUS 30 1/60mL
  • CHLORINE 30 1/60mL
  • CHLOROFORM 30 1/60mL
  • CINCHONA OFFICINALIS BARK 30 1/60mL
  • COENZYME A 30 1/60mL
  • CONIUM MACULATUM FLOWERING TOP 30 1/60mL
  • CORTICOTROPIN 30 1/60mL
  • DAPHNE ODORA BARK 30 1/60mL
  • DATURA STRAMONIUM 30 1/60mL
  • DELPHINIUM STAPHISAGRIA SEED 30 1/60mL
  • DIEFFENBACHIA SEGUINE 30 1/60mL
  • ECHINACEA PURPUREA 30 1/60mL
  • EPINEPHRINE 30 1/60mL
  • ESCHSCHOLZIA CALIFORNICA 30 1/60mL
  • FORMALDEHYDE 30 1/60mL
  • GLYCYRRHIZA GLABRA 30 1/60mL
  • GOLDENSEAL 30 1/60mL
  • HELIANTHUS ANNUUS FLOWERING TOP 30 1/60mL
  • HERRING SPERM DNA 30 1/60mL
  • HOPS 30 1/60mL
  • HORSE CHESTNUT 30 1/60mL
  • HYPERICUM PERFORATUM 30 1/60mL
  • JUGLANS REGIA FLOWERING TOP 30 1/60mL
  • JUNIPERUS COMMUNIS WHOLE 30 1/60mL
  • LEAD 30 1/60mL
  • LIQUID PETROLEUM 30 1/60mL
  • LOBARIA PULMONARIA 30 1/60mL
  • LOBELIA INFLATA 30 1/60mL
  • LONICERA PERICLYMENUM FLOWERING TWIG 30 1/60mL
  • LYCOPODIUM CLAVATUM SPORE 30 1/60mL
  • MATRICARIA RECUTITA 30 1/60mL
  • MERCURY 30 1/60mL
  • NICOTINE 30 1/60mL
  • OXOGLURIC ACID 30 1/60mL
  • PASSIFLORA INCARNATA FLOWERING TOP 30 1/60mL
  • PHENOL 30 1/60mL
  • PHYTOLACCA AMERICANA ROOT 30 1/60mL
  • PICEA MARIANA RESIN 30 1/60mL
  • PLANTAGO MAJOR 30 1/60mL
  • POTASSIUM CARBONATE 30 1/60mL
  • POTASSIUM CHLORIDE 30 1/60mL
  • POTASSIUM DICHROMATE 30 1/60mL
  • POTASSIUM IODIDE 30 1/60mL
  • POTASSIUM PHOSPHATE, DIBASIC 30 1/60mL
  • PULSATILLA PRATENSIS 30 [hp_C]/60mL
  • RICINUS COMMUNIS SEED 30 1/60mL
  • SCROPHULARIA NODOSA 30 1/60mL
  • SEMECARPUS ANACARDIUM JUICE 30 1/60mL
  • SODIUM CHLORIDE 30 1/60mL
  • SOLIDAGO VIRGAUREA FLOWERING TOP 30 1/60mL
  • STRYCHNOS IGNATII SEED 30 1/60mL
  • STRYCHNOS NUX-VOMICA SEED 30 1/60mL
  • SUCROSE 30 1/60mL
  • SULFUR IODIDE 30 1/60mL
  • SULFURIC ACID 30 1/60mL
  • SUS SCROFA PITUITARY GLAND 30 1/60mL
  • SYZYGIUM JAMBOS SEED 30 1/60mL
  • TARAXACUM OFFICINALE 30 1/60mL
  • THUJA OCCIDENTALIS LEAFY TWIG 30 1/60mL
  • TIN 30 1/60mL
  • TOBACCO LEAF 30 1/60mL
  • TRIBASIC CALCIUM PHOSPHATE 30 1/60mL

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.

  • CADMIUM SULFATE (UNII: 947UNF3Z6O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)

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: Primal Earth Llc
Labeler Code: 70034
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: 09-10-2015 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: 12-31-2017 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: E 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.

Tabakfre Product Label Images

Tabakfre 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

Otc - Active Ingredient

Equal amounts of each HPUS ingredient in 30C, 200C, 1M, LM1, LM2, LM3, LM4, & LM5 Potencies: Abies nigra, Aconitum napellus, Adrenalinum, Adrenocorticotrophin, Aesculus hippo flos, Agrimonia eupatoria flos, Alpha-katoglutaricum acidum, Alpha -lipoicum, acidum, Ammonium carbonicum, Ammonium arsenicicum, Antimonium crudum, Antimonium lartaricum, Arsenicum album, Arsenicum ioatum, Asarum europaeum, Avena sativa, Bel adonna, Bromium, Bryonia, Cadmium sulphuricum, Caladium seguinum, Calcarea iodata, Calcarea phosphorica, Capsicum annum, Carbolicum acidum, Carboneum oxygenisatum, Carboneum sulphuratum, Chamomilla, Chelidonium majus, chlorinum,Chloroformum, Cinchona officinalis, Coenzyme A. Colfea cruda, Conium maculatum, Daphne indica, DNA, Echinacea purpurea, Eschscholtzia californica, Eugenia jambosa, Formalinum, Glycyrrhiza glabra, Helianthus annus, Humulus lupulus, Hydrastis canadensis, Hypericum perforatum, Hypthalamus, Ignatia amara, juglans regia flos, Juniperus communis, Kali bichromicum, Kali Carbonicum, Kali iodatum, Kali muriaticum, Kali phophoricum, Lobelia inflata, Lonicera periclymenum, Lycopodium clavatum, Mercurius vivus, Natrum muriaticum, Nicotinum, Nux vornica, Passiflora incarnata, Petroleum, Phytolacca decandra, Pituitarum posterium, Plantago major, Plumbum metlicum, Pulsatilla, Quebracho, Ricinus cmmunis, Saccharum officinale, Scrophularia nodosa, Solidago virgaurea, Stannum metallicum, Staphysagria,Sticta pulmonaria, Stramonium, Sulphur iodatum, Sulphuricum acidum, Tabacum, Taraxacum officinale, Thuja occidentalis.

Otc - Purpose Section

For temporary relief of general symptoms of tobacco cravings including: tobacco cravings (smoking or chew-type tobaccos), headaches, shortness of breath, cough, nervousness, tightness in chest, irritability, restlessness, insomnia, craving for stimulants, nausea, toxic effcts from ingested  substances, enxiety, lightheadedness, dizziness and poor concentration.

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

Indications And Usage

For temporary relief of general symptoms of tobacco cravings including: tobacco cravings (smoking or chew type tobaccos), headaches, shortness of breath, cough, nervousness, tightness in chest, irritability, restlessness, insomnia, craving for stimulants, nausa, toxic effects from ingested substances, anxiety, lightheadedness, dizziness and poor concentration.

Dosage & Administration Section

Fill bottle dropper by squeezing the rubber dropper-top firmly and then releasing.Place full dropper of the liquid directly into mouth under the tongue.Hold under tongue for 30 seconds then swallow. use approximately 1 full dropper, 1 to 3 times daily, or as needed for relief of symptoms.A spray, fine mist or vapor can be created by placing 1 dropper into an atomizer and ten atomizing, 1 to 3 times per day, as needed for relief of symptoms.Use 5 days per week.Do not use more than directed.

Warnings

  • Do not use if you have ever had an allergic reaction to this product or any of its ingredients.Ask your doctor befgore use if you are under a doctor's care for any serious conditiontaking any other drugStop use and ask a doctor if symptoms persist, worsen, or if new symptoms occur.If pregnant or breast-feeding, ask a health professional before use.

Inactive Ingredient Section

Vegetable glycerin 10%, Purified Water.

* Please review the disclaimer below.

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