Label: TOBACCO WITHDRAWAL- arsenicum alb., benzoicum acidum, berber. vulg., bryonia, caladium seguinum, cantharis, ceanothus, chelidonium majus, chionanthus virginica, cinchona, daphne indica, ignatia, iris versicolor, lycopodium, nicotinum, nux vom., rhus toxicodendron, scutellaria lateriflora, tabacum, echinacea, taraxacum, valeriana pellet
- NDC Code(s): 55714-2535-1
- Packager: Newton Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 January 28, 2020
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Taraxacum 6x, Valeriana 6x, Arsenicum alb. 15x, Benzoicum acidum 15x, Berber. vulg. 15x, Bryonia 15x, Caladium seguinum 15x, Cantharis 15x, Ceanothus 15x, Chelidonium majus 15x, Chionanthus virginica 15x, Cinchona 15x, Daphne indica 15x, Ignatia 15x, Iris versicolor 15x, Lycopodium 15x, Nicotinum 15x, Nux vom. 15x, Rhus toxicodendron 15x, Scutellaria lateriflora 15x, Tabacum 15x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
- WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
TOBACCO WITHDRAWAL
arsenicum alb., benzoicum acidum, berber. vulg., bryonia, caladium seguinum, cantharis, ceanothus, chelidonium majus, chionanthus virginica, cinchona, daphne indica, ignatia, iris versicolor, lycopodium, nicotinum, nux vom., rhus toxicodendron, scutellaria lateriflora, tabacum, echinacea, taraxacum, valeriana pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2535 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF 15 [hp_X] in 1 g ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 g TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 6 [hp_X] in 1 g VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 6 [hp_X] in 1 g CHIONANTHUS VIRGINICUS BARK (UNII: S9Y4B22U2E) (CHIONANTHUS VIRGINICUS BARK - UNII:S9Y4B22U2E) CHIONANTHUS VIRGINICUS BARK 15 [hp_X] in 1 g CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 15 [hp_X] in 1 g DAPHNE ODORA BARK (UNII: JSJ34YQJ5D) (DAPHNE ODORA BARK - UNII:JSJ34YQJ5D) DAPHNE ODORA BARK 15 [hp_X] in 1 g STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 15 [hp_X] in 1 g IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT 15 [hp_X] in 1 g LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 15 [hp_X] in 1 g NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 15 [hp_X] in 1 g STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 15 [hp_X] in 1 g TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 15 [hp_X] in 1 g SCUTELLARIA LATERIFLORA WHOLE (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA WHOLE - UNII:7BP4DH5PDC) SCUTELLARIA LATERIFLORA WHOLE 15 [hp_X] in 1 g ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 15 [hp_X] in 1 g BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID 15 [hp_X] in 1 g BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK 15 [hp_X] in 1 g BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 15 [hp_X] in 1 g DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B) DIEFFENBACHIA SEGUINE 15 [hp_X] in 1 g LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA 15 [hp_X] in 1 g CEANOTHUS AMERICANUS LEAF (UNII: 25B1Y14T8N) (CEANOTHUS AMERICANUS LEAF - UNII:25B1Y14T8N) CEANOTHUS AMERICANUS LEAF 15 [hp_X] in 1 g CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 15 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-2535-1 28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2019 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-2535)
