ENERGY VITALITY ASSIST- aralia quinquefolia, arsenicum alb., baptisia, berber. aqui., bryonia, chelidonium majus, cinchona, coni

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

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Active ingredient:
American Ginseng (UNII: 8W75VCV53Q) (American Ginseng - UNII:8W75VCV53Q), Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV), Baptisia Tinctoria (UNII: 5K1UO2888Y) (Baptisia Tinctoria - UNII:5K1UO2888Y), Mahonia Aquifolium Root Bark (UNII: VZJ9F3C3SB) (Mahonia Aquifolium Root Bark - UNII:VZJ9F3C3SB), Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B), Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN), Cinchona Officinalis Bark (
Available from:
Newton Laboratories, Inc.
INN (International Name):
American Ginseng
Composition:
American Ginseng 15 [hp_X] in 1 mL
Administration route:
ORAL
Prescription type:
OTC
Therapeutic indications:
Formulated for symptoms associated with illness, lowered vitality and aging such as fatigue, debility, decreased appetite, enlarged glands and stress. Formulated for symptoms associated with illness, lowered vitality and aging such as fatigue, debility, decreased appetite, enlarged glands and stress.
Authorization status:
unapproved homeopathic
Authorization number:
55714-4284-1, 55714-4359-0, 55714-4359-1, 55714-4359-2

ENERGY VITALITY ASSIST- aralia quinquefolia, arsenicum alb., baptisia, berber. aqui.,

bryonia, chelidonium majus, cinchona, conium, glycyrrhiza glabra, hydrastis, iodium, kali carb.,

lachesis, lycopodium, nat. mur., nux vom., phosphorus, phytolacca, pulsatilla, hypericum,

taraxacum, urtica ur. liquid

ENERGY-VITALITY- aralia quinquefolia, arsenicum alb., baptisia, berber. aqui., bryonia,

chelidonium majus, cinchona, conium, glycyrrhiza glabra, hydrastis, iodium, kali carb., lachesis,

lycopodium, nat. mur., nux vom., phosphorus, phytolacca, pulsatilla, hypericum, taraxacum,

urtica ur. liquid

Newton Laboratories, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been

approved by FDA. For further information about unapproved drugs, click here.

----------

Energy-Vitality

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with illness, lowered vitality and aging such as fatigue, debility,

decreased appetite, enlarged glands and stress.

DOSAGE & ADMINISTRATION SECTION

Directions: Pets, under 50 lbs., give 3 drops by mouth (50 to 500 lbs. - 6 drops, over 500 lbs. - 1/2

teaspoon) one to four times daily or as directed by a health professional. Place in mouth or purified

water

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Hypericum 6x, Taraxacum 6x, Urtica ur. 6x, Aralia quin. 15x, Arsenicum alb.15x,

Baptisia 15x, Berber. aqui. 15x, Bryonia 15x, Chelidonium maj. 15x, Cinchona 15x, Conium 15x,

Hydrastis 15x, Iodium 15x, Kali carb. 15x, Lachesis 15x, Lycopodium 15x, Nat. mur. 15x, Nux vom. 15x,

Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Glycyrrhiza 16x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with illness, lowered vitality and aging such as fatigue, debility,

decreased appetite, enlarged glands and stress.

INACTIVE INGREDIENT SECTION

USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 -

Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or

missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or

breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use..

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL

ENERGY VITALITY ASSIST

aralia quinquefolia, arsenicum alb., baptisia, berber. aqui., bryonia, chelidonium majus, cinchona, conium,

glycyrrhiza glabra, hydrastis, iodium, kali carb., lachesis, lycopodium, nat. mur., nux vom., phosphorus, phytolacca,

pulsatilla, hypericum, taraxacum, urtica ur. liquid

Product Information

Product T ype

OTC ANIMAL DRUG

Ite m Code (Source )

NDC:55714-4359

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

America n Ginseng (UNII: 8 W75VCV53Q) (American Ginseng - UNII:8 W75VCV53Q)

American Ginseng

15 [hp_X]

in 1 mL

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

Arsenic Trio xide

15 [hp_X]

in 1 mL

Ba ptisia Tincto ria (UNII: 5K1UO28 8 8 Y) (Baptisia Tincto ria - UNII:5K1UO28 8 8 Y)

Baptisia Tincto ria

15 [hp_X]

in 1 mL

Ma ho nia Aquifo lium Ro o t Ba rk (UNII: VZJ9 F3C3SB) (Maho nia Aquifo lium Ro o t Bark -

UNII:VZJ9 F3C3SB)

Maho nia Aquifo lium Ro o t

Ba rk

15 [hp_X]

in 1 mL

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 mL

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 mL

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 mL

Co nium Ma cula tum Flo wering To p (UNII: Q28 R5GF371) (Co nium Maculatum Flo wering

To p - UNII:Q28 R5GF371)

Co nium Maculatum

Flo wering To p

15 [hp_X]

in 1 mL

Glycyrrhiza Gla bra (UNII: 278 8 Z9 758 H) (Glycyrrhiza Glabra - UNII:278 8 Z9 758 H)

Glycyrrhiza Glabra

15 [hp_X]

in 1 mL

Go ldensea l (UNII: ZW3Z11D0 JV) (Go ldenseal - UNII:ZW3Z11D0 JV)

Go lde nse a l

15 [hp_X]

in 1 mL

Io dine (UNII: 9 6 79 TC0 7X4) (Io dine - UNII:9 6 79 TC0 7X4)

Io dine

15 [hp_X]

in 1 mL

Po ta ssium Ca rbo na te (UNII: BQN1B9 B9 HA) (Carbo nate Io n - UNII:7UJQ5OPE7D)

Po tassium Carbo nate

15 [hp_X]

in 1 mL

La chesis Muta Veno m (UNII: VSW71SS0 7I) (Lachesis Muta Veno m - UNII:VSW71SS0 7I)

Lachesis Muta Veno m

15 [hp_X]

in 1 mL

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 mL

So dium Chlo ride (UNII: 451W47IQ8 X) (Chlo ride Io n - UNII:Q32ZN48 6 9 8 )

So dium Chlo ride

15 [hp_X]

in 1 mL

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 mL

Pho spho rus (UNII: 27YLU75U4W) (Pho spho rus - UNII:27YLU75U4W)

Pho spho rus

15 [hp_X]

in 1 mL

Phyto la cca America na Ro o t (UNII: 11E6 VI8 VEG) (Phyto lacca Americana Ro o t -

UNII:11E6 VI8 VEG)

Phyto lacca Americana

Ro o t

15 [hp_X]

in 1 mL

Pulsa tilla Vulg a ris (UNII: I76 KB35JEV) (Pulsatilla Vulgaris - UNII:I76 KB35JEV)

Pulsatilla Vulgaris

15 [hp_X]

in 1 mL

Hypericum Perfo ra tum (UNII: XK4IUX8 MNB) (Hypericum Perfo ratum -

UNII:XK4IUX8 MNB)

Hypericum Perfo ratum

3 [hp_X]

in 1 mL

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 mL

Urtica Urens (UNII: IHN2NQ5OF9 ) (Urtica Urens - UNII:IHN2NQ5OF9 )

Urtica Urens

3 [hp_X]

Urtica Urens (UNII: IHN2NQ5OF9 ) (Urtica Urens - UNII:IHN2NQ5OF9 )

Urtica Urens

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Alco ho l (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55714-4359 -1

29 .57 mL in 1 BOTTLE, GLASS

2

NDC:55714-4359 -2

59 .14 mL in 1 BOTTLE, GLASS

3

NDC:55714-4359 -0

14.78 mL 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

12/31/20 18

ENERGY-VITALITY

aralia quinquefolia, arsenicum alb., baptisia, berber. aqui., bryonia, chelidonium majus, cinchona, conium,

glycyrrhiza glabra, hydrastis, iodium, kali carb., lachesis, lycopodium, nat. mur., nux vom., phosphorus, phytolacca,

pulsatilla, hypericum, taraxacum, urtica ur. liquid

Product Information

Product T ype

OTC ANIMAL DRUG

Ite m Code (Source )

NDC:55714-428 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

America n Ginseng (UNII: 8 W75VCV53Q) (American Ginseng - UNII:8 W75VCV53Q)

American Ginseng

15 [hp_X]

in 1 mL

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

Arsenic Trio xide

15 [hp_X]

in 1 mL

Ba ptisia Tincto ria (UNII: 5K1UO28 8 8 Y) (Baptisia Tincto ria - UNII:5K1UO28 8 8 Y)

Baptisia Tincto ria

15 [hp_X]

in 1 mL

Ma ho nia Aquifo lium Ro o t Ba rk (UNII: VZJ9 F3C3SB) (Maho nia Aquifo lium Ro o t Bark -

UNII:VZJ9 F3C3SB)

Maho nia Aquifo lium Ro o t

Ba rk

15 [hp_X]

in 1 mL

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 mL

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 mL

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 mL

Co nium Ma cula tum Flo wering To p (UNII: Q28 R5GF371) (Co nium Maculatum Flo wering

To p - UNII:Q28 R5GF371)

Co nium Maculatum

Flo wering To p

15 [hp_X]

in 1 mL

Glycyrrhiza Gla bra (UNII: 278 8 Z9 758 H) (Glycyrrhiza Glabra - UNII:278 8 Z9 758 H)

Glycyrrhiza Glabra

16 [hp_X]

Glycyrrhiza Gla bra (UNII: 278 8 Z9 758 H) (Glycyrrhiza Glabra - UNII:278 8 Z9 758 H)

Glycyrrhiza Glabra

in 1 mL

Go ldensea l (UNII: ZW3Z11D0 JV) (Go ldenseal - UNII:ZW3Z11D0 JV)

Go lde nse a l

15 [hp_X]

in 1 mL

Io dine (UNII: 9 6 79 TC0 7X4) (Io dine - UNII:9 6 79 TC0 7X4)

Io dine

15 [hp_X]

in 1 mL

Po ta ssium Ca rbo na te (UNII: BQN1B9 B9 HA) (Carbo nate Io n - UNII:7UJQ5OPE7D)

Po tassium Carbo nate

15 [hp_X]

in 1 mL

La chesis Muta Veno m (UNII: VSW71SS0 7I) (Lachesis Muta Veno m - UNII:VSW71SS0 7I)

Lachesis Muta Veno m

15 [hp_X]

in 1 mL

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 mL

So dium Chlo ride (UNII: 451W47IQ8 X) (Chlo ride Io n - UNII:Q32ZN48 6 9 8 )

So dium Chlo ride

15 [hp_X]

in 1 mL

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 mL

Pho spho rus (UNII: 27YLU75U4W) (Pho spho rus - UNII:27YLU75U4W)

Pho spho rus

15 [hp_X]

in 1 mL

Phyto la cca America na Ro o t (UNII: 11E6 VI8 VEG) (Phyto lacca Americana Ro o t -

UNII:11E6 VI8 VEG)

Phyto lacca Americana

Ro o t

15 [hp_X]

in 1 mL

Pulsa tilla Vulg a ris (UNII: I76 KB35JEV) (Pulsatilla Vulgaris - UNII:I76 KB35JEV)

Pulsatilla Vulgaris

15 [hp_X]

in 1 mL

Hypericum Perfo ra tum (UNII: XK4IUX8 MNB) (Hypericum Perfo ratum -

UNII:XK4IUX8 MNB)

Hypericum Perfo ratum

6 [hp_X]

in 1 mL

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

Taraxacum Officinale

6 [hp_X]

in 1 mL

Urtica Urens (UNII: IHN2NQ5OF9 ) (Urtica Urens - UNII:IHN2NQ5OF9 )

Urtica Urens

6 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Alco ho l (UNII: 3K9 9 58 V9 0 M)

Wa ter (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55714-428 4-1

30 mL in 1 BOTTLE, GLASS

2

NDC:55714-428 4-0

15 mL 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 1/14/20 19

Labeler -

Newton Laboratories, Inc. (788793610)

Registrant -

Newton Laboratories, Inc. (788793610)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Newton Laboratories, Inc.

Newto n Labo rato ries, Inc.

78 8 79 36 10

MANUFACTURE, API MANUFACTURE

Revised: 1/2019

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