TABAKFRE- equal amounts of each hpus ingredient in 30c, 200c, 1m, lm1, lm2, lm3, lm4, and lm5 potencies solution

Tabakfre by

Drug Labeling and Warnings

Tabakfre by is a Homeopathic medication manufactured, distributed, or labeled by Primal Earth LLC, Integra Health International, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 condition
• taking any other drug

Stop 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TABAKFRE 
equal amounts of each hpus ingredient in 30c, 200c, 1m, lm1, lm2, lm3, lm4, and lm5 potencies solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70034-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	30 [hp_C]  in 60 mL
.ALPHA.-LIPOIC ACID, (+/-)- (UNII: 73Y7P0K73Y) (.ALPHA.-LIPOIC ACID, (+/-)- - UNII:73Y7P0K73Y)	.ALPHA.-LIPOIC ACID, (+/-)-	30 [hp_C]  in 60 mL
AGRIMONIA EUPATORIA FLOWER (UNII: 5811MI029U) (AGRIMONIA EUPATORIA FLOWER - UNII:5811MI029U)	AGRIMONIA EUPATORIA FLOWER	30 [hp_C]  in 60 mL
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X)	AMMONIA	30 [hp_C]  in 60 mL
AMMONIUM CARBONATE (UNII: NJ5VT0FKLJ) (AMMONIUM CATION - UNII:54S68520I4)	AMMONIUM CARBONATE	30 [hp_C]  in 60 mL
ANTIMONY ARSENATE (UNII: WE3458XNFT) (ARSENATE ION - UNII:G1DBI405OK)	ANTIMONY ARSENATE	30 [hp_C]  in 60 mL
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY POTASSIUM TARTRATE	30   in 60 mL
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U)	ANTIMONY TRISULFIDE	30   in 60 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	30   in 60 mL
ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIIODIDE	30   in 60 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	30   in 60 mL
ASARUM EUROPAEUM (UNII: H0876AL67A) (ASARUM EUROPAEUM - UNII:H0876AL67A)	ASARUM EUROPAEUM	30   in 60 mL
ASPIDOSPERMA QUEBRACHO-BLANCO BARK (UNII: 52B1340190) (ASPIDOSPERMA QUEBRACHO-BLANCO BARK - UNII:52B1340190)	ASPIDOSPERMA QUEBRACHO-BLANCO BARK	30   in 60 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	30   in 60 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	30   in 60 mL
BOS TAURUS HYPOTHALAMUS (UNII: S6G2NLH4Y7) (BOS TAURUS HYPOTHALAMUS - UNII:S6G2NLH4Y7)	BOS TAURUS HYPOTHALAMUS	30   in 60 mL
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G)	BROMINE	30   in 60 mL
CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM IODIDE	30   in 60 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	30   in 60 mL
CARBON DISULFIDE (UNII: S54S8B99E8) (CARBON DISULFIDE - UNII:S54S8B99E8)	CARBON DISULFIDE	30   in 60 mL
CARBON MONOXIDE (UNII: 7U1EE4V452) (CARBON MONOXIDE - UNII:7U1EE4V452)	CARBON MONOXIDE	30   in 60 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	30   in 60 mL
CHLORINE (UNII: 4R7X1O2820) (CHLORINE - UNII:4R7X1O2820)	CHLORINE	30   in 60 mL
CHLOROFORM (UNII: 7V31YC746X) (CHLOROFORM - UNII:7V31YC746X)	CHLOROFORM	30   in 60 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	30   in 60 mL
COENZYME A (UNII: SAA04E81UX) (COENZYME A - UNII:SAA04E81UX)	COENZYME A	30   in 60 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	30   in 60 mL
CORTICOTROPIN (UNII: K0U68Q2TXA) (CORTICOTROPIN - UNII:K0U68Q2TXA)	CORTICOTROPIN	30   in 60 mL
DAPHNE ODORA BARK (UNII: JSJ34YQJ5D) (DAPHNE ODORA BARK - UNII:JSJ34YQJ5D)	DAPHNE ODORA BARK	30   in 60 mL
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3)	DATURA STRAMONIUM	30   in 60 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	30   in 60 mL
DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B)	DIEFFENBACHIA SEGUINE	30   in 60 mL
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	30   in 60 mL
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	30   in 60 mL
ESCHSCHOLZIA CALIFORNICA (UNII: 9315HN272X) (ESCHSCHOLZIA CALIFORNICA - UNII:9315HN272X)	ESCHSCHOLZIA CALIFORNICA	30   in 60 mL
FORMALDEHYDE (UNII: 1HG84L3525) (FORMALDEHYDE - UNII:1HG84L3525)	FORMALDEHYDE	30   in 60 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H)	GLYCYRRHIZA GLABRA	30   in 60 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	30   in 60 mL
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) (HELIANTHUS ANNUUS FLOWERING TOP - UNII:BKJ0J3D1BP)	HELIANTHUS ANNUUS FLOWERING TOP	30   in 60 mL
HERRING SPERM DNA (UNII: 51FI676N6F) (HERRING SPERM DNA - UNII:51FI676N6F)	HERRING SPERM DNA	30   in 60 mL
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	30   in 60 mL
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ)	HORSE CHESTNUT	30   in 60 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	30   in 60 mL
JUGLANS REGIA FLOWERING TOP (UNII: 3BA2N709NG) (JUGLANS REGIA FLOWERING TOP - UNII:3BA2N709NG)	JUGLANS REGIA FLOWERING TOP	30   in 60 mL
JUNIPERUS COMMUNIS WHOLE (UNII: 464910T5N9) (JUNIPERUS COMMUNIS WHOLE - UNII:464910T5N9)	JUNIPERUS COMMUNIS WHOLE	30   in 60 mL
LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P)	LEAD	30   in 60 mL
LIQUID PETROLEUM (UNII: 6ZAE7X688J) (LIQUID PETROLEUM - UNII:6ZAE7X688J)	LIQUID PETROLEUM	30   in 60 mL
LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (LOBARIA PULMONARIA - UNII:D1YM0P5Z2T)	LOBARIA PULMONARIA	30   in 60 mL
LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U)	LOBELIA INFLATA	30   in 60 mL
LONICERA PERICLYMENUM FLOWERING TWIG (UNII: O263S43457) (LONICERA PERICLYMENUM FLOWERING TWIG - UNII:O263S43457)	LONICERA PERICLYMENUM FLOWERING TWIG	30   in 60 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30   in 60 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	30   in 60 mL
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL)	MERCURY	30   in 60 mL
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	30   in 60 mL
OXOGLURIC ACID (UNII: 8ID597Z82X) (.ALPHA.-KETOGLUTARIC ACID - UNII:8ID597Z82X)	OXOGLURIC ACID	30   in 60 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	30   in 60 mL
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	30   in 60 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	30   in 60 mL
PICEA MARIANA RESIN (UNII: 71AOV0W131) (PICEA MARIANA RESIN - UNII:71AOV0W131)	PICEA MARIANA RESIN	30   in 60 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	30   in 60 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	30   in 60 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CATION	30   in 60 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	30   in 60 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	30   in 60 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	30   in 60 mL
PULSATILLA PRATENSIS (UNII: 8E272251DI) (PULSATILLA PRATENSIS - UNII:8E272251DI)	PULSATILLA PRATENSIS	30 [hp_C]  in 60 mL
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX) (RICINUS COMMUNIS SEED - UNII:7EK4SFN1TX)	RICINUS COMMUNIS SEED	30   in 60 mL
SCROPHULARIA NODOSA (UNII: 7H443NUB2T) (SCROPHULARIA NODOSA - UNII:7H443NUB2T)	SCROPHULARIA NODOSA	30   in 60 mL
SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU)	SEMECARPUS ANACARDIUM JUICE	30   in 60 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30   in 60 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	30   in 60 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	30   in 60 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	30   in 60 mL
SUCROSE (UNII: C151H8M554) (SUCROSE - UNII:C151H8M554)	SUCROSE	30   in 60 mL
SULFUR IODIDE (UNII: L6L8KA2AA0) (SULFUR IODIDE - UNII:L6L8KA2AA0)	SULFUR IODIDE	30   in 60 mL
SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF)	SULFURIC ACID	30   in 60 mL
SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T)	SUS SCROFA PITUITARY GLAND	30   in 60 mL
SYZYGIUM JAMBOS SEED (UNII: 97P0H45869) (SYZYGIUM JAMBOS SEED - UNII:97P0H45869)	SYZYGIUM JAMBOS SEED	30   in 60 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	30   in 60 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	30   in 60 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5)	TIN	30   in 60 mL
TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU)	TOBACCO LEAF	30   in 60 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	30   in 60 mL

Inactive Ingredients
Ingredient Name	Strength
CADMIUM SULFATE (UNII: 947UNF3Z6O)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70034-001-01	60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/10/2015

Labeler - Primal Earth LLC (052466758)

Establishment
Name	Address	ID/FEI	Business Operations
Integra Health International, S.A. de C.V.		589880301	manufacture(70034-001)