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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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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

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.

image description

TABAKFRE 
equal amounts of each hpus ingredient in 30c, 200c, 1m, lm1, lm2, lm3, lm4, and lm5 potencies solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70034-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [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 FLOWER30 [hp_C]  in 60 mL
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA30 [hp_C]  in 60 mL
AMMONIUM CARBONATE (UNII: NJ5VT0FKLJ) (AMMONIUM CATION - UNII:54S68520I4) AMMONIUM CARBONATE30 [hp_C]  in 60 mL
ANTIMONY ARSENATE (UNII: WE3458XNFT) (ARSENATE ION - UNII:G1DBI405OK) ANTIMONY ARSENATE30 [hp_C]  in 60 mL
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE30   in 60 mL
ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE30   in 60 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN30   in 60 mL
ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIIODIDE30   in 60 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE30   in 60 mL
ASARUM EUROPAEUM (UNII: H0876AL67A) (ASARUM EUROPAEUM - UNII:H0876AL67A) ASARUM EUROPAEUM30   in 60 mL
ASPIDOSPERMA QUEBRACHO-BLANCO BARK (UNII: 52B1340190) (ASPIDOSPERMA QUEBRACHO-BLANCO BARK - UNII:52B1340190) ASPIDOSPERMA QUEBRACHO-BLANCO BARK30   in 60 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30   in 60 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP30   in 60 mL
BOS TAURUS HYPOTHALAMUS (UNII: S6G2NLH4Y7) (BOS TAURUS HYPOTHALAMUS - UNII:S6G2NLH4Y7) BOS TAURUS HYPOTHALAMUS30   in 60 mL
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE30   in 60 mL
CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM IODIDE30   in 60 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM30   in 60 mL
CARBON DISULFIDE (UNII: S54S8B99E8) (CARBON DISULFIDE - UNII:S54S8B99E8) CARBON DISULFIDE30   in 60 mL
CARBON MONOXIDE (UNII: 7U1EE4V452) (CARBON MONOXIDE - UNII:7U1EE4V452) CARBON MONOXIDE30   in 60 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS30   in 60 mL
CHLORINE (UNII: 4R7X1O2820) (CHLORINE - UNII:4R7X1O2820) CHLORINE30   in 60 mL
CHLOROFORM (UNII: 7V31YC746X) (CHLOROFORM - UNII:7V31YC746X) CHLOROFORM30   in 60 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK30   in 60 mL
COENZYME A (UNII: SAA04E81UX) (COENZYME A - UNII:SAA04E81UX) COENZYME A30   in 60 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP30   in 60 mL
CORTICOTROPIN (UNII: K0U68Q2TXA) (CORTICOTROPIN - UNII:K0U68Q2TXA) CORTICOTROPIN30   in 60 mL
DAPHNE ODORA BARK (UNII: JSJ34YQJ5D) (DAPHNE ODORA BARK - UNII:JSJ34YQJ5D) DAPHNE ODORA BARK30   in 60 mL
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM30   in 60 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED30   in 60 mL
DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B) DIEFFENBACHIA SEGUINE30   in 60 mL
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA30   in 60 mL
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE30   in 60 mL
ESCHSCHOLZIA CALIFORNICA (UNII: 9315HN272X) (ESCHSCHOLZIA CALIFORNICA - UNII:9315HN272X) ESCHSCHOLZIA CALIFORNICA30   in 60 mL
FORMALDEHYDE (UNII: 1HG84L3525) (FORMALDEHYDE - UNII:1HG84L3525) FORMALDEHYDE30   in 60 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA30   in 60 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL30   in 60 mL
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) (HELIANTHUS ANNUUS FLOWERING TOP - UNII:BKJ0J3D1BP) HELIANTHUS ANNUUS FLOWERING TOP30   in 60 mL
HERRING SPERM DNA (UNII: 51FI676N6F) (HERRING SPERM DNA - UNII:51FI676N6F) HERRING SPERM DNA30   in 60 mL
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS30   in 60 mL
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT30   in 60 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30   in 60 mL
JUGLANS REGIA FLOWERING TOP (UNII: 3BA2N709NG) (JUGLANS REGIA FLOWERING TOP - UNII:3BA2N709NG) JUGLANS REGIA FLOWERING TOP30   in 60 mL
JUNIPERUS COMMUNIS WHOLE (UNII: 464910T5N9) (JUNIPERUS COMMUNIS WHOLE - UNII:464910T5N9) JUNIPERUS COMMUNIS WHOLE30   in 60 mL
LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD30   in 60 mL
LIQUID PETROLEUM (UNII: 6ZAE7X688J) (LIQUID PETROLEUM - UNII:6ZAE7X688J) LIQUID PETROLEUM30   in 60 mL
LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (LOBARIA PULMONARIA - UNII:D1YM0P5Z2T) LOBARIA PULMONARIA30   in 60 mL
LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U) LOBELIA INFLATA30   in 60 mL
LONICERA PERICLYMENUM FLOWERING TWIG (UNII: O263S43457) (LONICERA PERICLYMENUM FLOWERING TWIG - UNII:O263S43457) LONICERA PERICLYMENUM FLOWERING TWIG30   in 60 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30   in 60 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA30   in 60 mL
MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY30   in 60 mL
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE30   in 60 mL
OXOGLURIC ACID (UNII: 8ID597Z82X) (.ALPHA.-KETOGLUTARIC ACID - UNII:8ID597Z82X) OXOGLURIC ACID30   in 60 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP30   in 60 mL
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL30   in 60 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT30   in 60 mL
PICEA MARIANA RESIN (UNII: 71AOV0W131) (PICEA MARIANA RESIN - UNII:71AOV0W131) PICEA MARIANA RESIN30   in 60 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR30   in 60 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE30   in 60 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION30   in 60 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE30   in 60 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION30   in 60 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC30   in 60 mL
PULSATILLA PRATENSIS (UNII: 8E272251DI) (PULSATILLA PRATENSIS - UNII:8E272251DI) PULSATILLA PRATENSIS30 [hp_C]  in 60 mL
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX) (RICINUS COMMUNIS SEED - UNII:7EK4SFN1TX) RICINUS COMMUNIS SEED30   in 60 mL
SCROPHULARIA NODOSA (UNII: 7H443NUB2T) (SCROPHULARIA NODOSA - UNII:7H443NUB2T) SCROPHULARIA NODOSA30   in 60 mL
SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE30   in 60 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30   in 60 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP30   in 60 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED30   in 60 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30   in 60 mL
SUCROSE (UNII: C151H8M554) (SUCROSE - UNII:C151H8M554) SUCROSE30   in 60 mL
SULFUR IODIDE (UNII: L6L8KA2AA0) (SULFUR IODIDE - UNII:L6L8KA2AA0) SULFUR IODIDE30   in 60 mL
SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID30   in 60 mL
SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T) SUS SCROFA PITUITARY GLAND30   in 60 mL
SYZYGIUM JAMBOS SEED (UNII: 97P0H45869) (SYZYGIUM JAMBOS SEED - UNII:97P0H45869) SYZYGIUM JAMBOS SEED30   in 60 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE30   in 60 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG30   in 60 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN30   in 60 mL
TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF30   in 60 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION30   in 60 mL
Inactive Ingredients
Ingredient NameStrength
CADMIUM SULFATE (UNII: 947UNF3Z6O)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70034-001-0160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/10/2015
Labeler - Primal Earth LLC (052466758)
Establishment
NameAddressID/FEIBusiness Operations
Integra Health International, S.A. de C.V.589880301manufacture(70034-001)

Revised: 10/2015
Document Id: 16714dac-df60-4a15-b59a-733febac091a
Set id: 22de9aa2-83f1-4453-9d14-13af3e3aee9f
Version: 1
Effective Time: 20151020
 
Primal Earth LLC