TOBACCO WITHDRAWAL - arsenicum alb., benzoicum acidum, berber. vulg., bryonia, caladium seguinum, cantharis, ceanothus, chelidon

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV), Benzoic Acid (UNII: 8SKN0B0MIM) (Benzoic Acid - UNII:8SKN0B0MIM), Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U), Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B), Dieffenbachia Seguine (UNII: 01800C6E6B) (Dieffenbachia Seguine - UNII:01800C6E6B), Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT), Ceanothus Americanus Leaf (UNII: 25B1
Available from:
Newton Laboratories, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Tobacco Withdrawal   Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory conditions and stress caused by abstinence.  Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory conditions and stress caused by abstinence.
Authorization status:
unapproved homeopathic
Authorization number:
55714-2259-0, 55714-2259-1, 55714-2259-2

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

Newton Laboratories, Inc.

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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Tobacco Withdrawal

INDICATIONS & USAGE SECTION

Tobacco Withdrawal Formulated for symptoms associated with tobacco use such as anxiety, cravings,

irritability, respiratory conditions and stress caused by abstinence.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults, take 6 pellets orally as needed or as directed by a healthcare professional.

Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

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, Echinacea 3x, Taraxacum 3x,

Valeriana 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory

conditions and stress caused by abstinence.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions? 1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare

professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out

of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for

more than a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE 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

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55714-2259

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Arsenic Trio xide (UNII: S7V9 2P6 7HO) (Arsenic Catio n (3+) - UNII:C9 6 6 13F5AV)

Arsenic Trio xide

15 [hp_X]

in 1 g

Benzo ic Acid (UNII: 8 SKN0 B0 MIM) (Benzo ic Acid - UNII:8 SKN0 B0 MIM)

Benzo ic Acid

15 [hp_X]

in 1 g

Berberis Vulg a ris Ro o t Ba rk (UNII: 1TH8 Q20 J0 U) (Berberis Vulgaris Ro o t Bark -

UNII:1TH8 Q20 J0 U)

Berberis Vulgaris Ro o t

Ba rk

15 [hp_X]

in 1 g

Bryo nia Alba Ro o t (UNII: T7J0 46 YI2B) (Bryo nia Alba Ro o t - UNII:T7J0 46 YI2B)

Bryo nia Alba Ro o t

15 [hp_X]

in 1 g

Dieffenba chia Seg uine (UNII: 0 18 0 0 C6 E6 B) (Dieffenbachia Seguine -

UNII:0 18 0 0 C6 E6 B)

Dieffenbachia Seguine

15 [hp_X]

in 1 g

Lytta Vesica to ria (UNII: 3Q0 34RO3BT) (Lytta Vesicato ria - UNII:3Q0 34RO3BT)

Lytta Vesicato ria

15 [hp_X]

in 1 g

Cea no thus America nus Lea f (UNII: 25B1Y14T8 N) (Ceano thus Americanus Leaf -

UNII:25B1Y14T8 N)

Ceano thus Americanus

Le a f

15 [hp_X]

in 1 g

Chelido nium Ma j us (UNII: 7E8 8 9 U5RNN) (Chelido nium Majus - UNII:7E8 8 9 U5RNN)

Chelido nium Majus

15 [hp_X]

in 1 g

Chio na nthus Virg inicus Ba rk (UNII: S9 Y4B22U2E) (Chio nanthus Virginicus Bark -

UNII:S9 Y4B22U2E)

Chio nanthus Virginicus

Ba rk

15 [hp_X]

in 1 g

Cincho na O fficina lis Ba rk (UNII: S0 0 3A158 SB) (Cincho na Officinalis Bark -

UNII:S0 0 3A158 SB)

Cincho na Officinalis Bark

15 [hp_X]

in 1 g

Da phne O do ra Ba rk (UNII: JSJ34YQJ5D) (Daphne Odo ra Bark - UNII:JSJ34YQJ5D)

Daphne Odo ra Bark

15 [hp_X]

in 1 g

Strychno s Ig na tii Seed (UNII: 1NM3M248 7K) (Strychno s Ignatii Seed - UNII:1NM3M248 7K)

Strychno s Ignatii Seed

15 [hp_X]

in 1 g

Iris Versico lo r Ro o t (UNII: X43D4L3DQC) (Iris Versico lo r Ro o t - UNII:X43D4L3DQC)

Iris Versico lo r Ro o t

15 [hp_X]

in 1 g

Lyco po dium Cla va tum Spo re (UNII: C8 8 X29 Y479 ) (Lyco po dium Clavatum Spo re -

UNII:C8 8 X29 Y479 )

Lyco po dium Clavatum

Spo re

15 [hp_X]

in 1 g

Nico tine (UNII: 6 M3C8 9 ZY6 R) (Nico tine - UNII:6 M3C8 9 ZY6 R)

Nic o tine

15 [hp_X]

in 1 g

Strychno s Nux-vo mica Seed (UNII: 26 9 XH139 19 ) (Strychno s Nux-vo mica Seed -

UNII:26 9 XH139 19 )

Strychno s Nux-vo mica

Se e d

15 [hp_X]

in 1 g

To xico dendro n Pubescens Lea f (UNII: 6 IO18 2RP7A) (To xico dendro n Pubescens Leaf -

UNII:6 IO 18 2RP7A)

To xico dendro n Pubescens

Le a f

15 [hp_X]

in 1 g

Scutella ria La teriflo ra (UNII: 7BP4DH5PDC) (Scutellaria Lateriflo ra - UNII:7BP4DH5PDC)

Scutellaria Lateriflo ra

15 [hp_X]

in 1 g

To ba cco Lea f (UNII: 6 YR26 0 8 RSU) (To bacco Leaf - UNII:6 YR26 0 8 RSU)

To bacco Leaf

15 [hp_X]

in 1 g

Echina cea , Unspecified (UNII: 4N9 P6 CC1DX) (Echinacea, Unspecified -

UNII:4N9 P6 CC1DX)

Echinacea, Unspecified

3 [hp_X]

in 1 g

Ta ra xa cum O fficina le (UNII: 39 9 8 1FM375) (Taraxacum Officinale - UNII:39 9 8 1FM375)

Taraxacum Officinale

3 [hp_X]

in 1 g

Va leria n (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW)

Va le ria n

3 [hp_X]

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Sucro se (UNII: C151H8 M554)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55714-2259 -1

28 .35 g in 1 BOTTLE, GLASS

2

NDC:55714-2259 -2

56 .7 g in 1 BOTTLE, GLASS

3

NDC:55714-2259 -0

7.0 8 g in 1 BOTTLE, GLASS

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 3/0 1/20 11

Newton Laboratories, Inc.

Labeler -

Newton Laboratories, Inc. (788793610)

Registrant -

Newton Laboratories, Inc. (788793610)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Newto n Labo rato ries, Inc.

78 8 79 36 10

MANUFACTURE(55714-2259 )

Revised: 3/2011

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