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

  • NDC Code(s): 55138-017-01
  • Packager: Integra Health International, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated September 8, 2015

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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

    image description

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:55138-017
    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:55138-017-0160 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 - Integra Health International, S.A. de C.V. (589880301)
    Establishment
    NameAddressID/FEIBusiness Operations
    Integra Health International, S.A. de C.V.589880301manufacture(55138-017)