NERVOUSNESS - FEAR- arg. nit., bryonia, coffea cruda, cypripedium, gelsemium, hypericum, ignatia, iodium, kali brom., mag. phos.

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

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Active ingredient:
Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A), Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B), Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72), Cypripedium Parviflorum Var. Pubescens Root (UNII: 21Y9GZ1LZA) (Cypripedium Parviflorum Var. Pubescens Root - UNII:21Y9GZ1LZA), Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q), Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perfor
Available from:
Newton Laboratories, Inc.
INN (International Name):
Silver Nitrate
Composition:
Silver Nitrate 15 [hp_X] in 1 mL
Administration route:
ORAL
Prescription type:
OTC
Therapeutic indications:
Formulated for associated symptoms such as aggression, hypersensitivity, tremors, nervous habits, separation anxiety and loss of appetite. Formulated for associated symptoms such as aggression, hypersensitivity, tremors, nervous habits, separation anxiety and loss of appetite.
Authorization status:
unapproved homeopathic
Authorization number:
55714-4292-1, 55714-4299-1, 55714-4299-2

NERVOUSNESS - FEAR- arg. nit., bryonia, coffea cruda, cypripedium, gelsemium, hypericum,

ignatia, iodium, kali brom., mag. phos., nat. mur., nux vom., sambucus nig., sepia,

stramonium,theridion, zinc. met., chamomilla, passiflora,valeriana 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.

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Nervousness - Fear

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as aggression, hypersensitivity, tremors, nervous habits,

separation anxiety and loss of appetite.

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) as needed or as directed by a health professional. Place in mouth or purified water.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Chamomilla 6x, Passiflora 6x, Valeriana 6x, Arg. nit. 15x, Bryonia 15x, Coffea cruda

15x, Cypripedium 15x, Gelsemium 15x, Hypericum 15x, Ignatia 15x, Iodium 15x, Kali brom. 15x, Mag.

phos. 15x, Nat. mur. 15x, Nux vom. 15x, Sambucus nig. 15x, Sepia 15x, Stramonium 15x,Theridion 15x,

Zinc. met. 15x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as aggression, hypersensitivity, tremors, nervous habits,

separation anxiety and loss of appetite.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: 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: 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

NERVOUSNESS - FEAR

arg. nit., bryonia, coffea cruda, cypripedium, gelsemium, hypericum, ignatia, iodium, kali brom., mag. phos., nat.

mur., nux vom., sambucus nig., sepia, stramonium,theridion, zinc. met., chamomilla, passiflora,valeriana liquid

Product Information

Product T ype

OTC ANIMAL DRUG

Ite m Code (Source )

NDC:55714-429 9

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Silver Nitra te (UNII: 9 5IT3W8 JZE) (Silver Catio n - UNII:57N7B0 K9 0 A)

Silver Nitrate

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

Ara bica Co ffee Bea n (UNII: 3SW6 78 MX72) (Arabica Co ffee Bean - UNII:3SW6 78 MX72)

Arabica Co ffee Bean

15 [hp_X]

in 1 mL

Cypripedium Pa rviflo rum Va r. Pubescens Ro o t (UNII: 21Y9 GZ1LZA) (Cypripedium

Parviflo rum Var. Pubescens Ro o t - UNII:21Y9 GZ1LZA)

Cypripedium Parviflo rum Var.

Pubescens Ro o t

15 [hp_X]

in 1 mL

Gelsemium Sempervirens Ro o t (UNII: 6 39 KR6 0 Q1Q) (Gelsemium Sempervirens Ro o t -

UNII:6 39 KR6 0 Q1Q)

Gelsemium Sempervirens

Ro o t

15 [hp_X]

in 1 mL

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

UNII:XK4IUX8 MNB)

Hypericum Perfo ratum

15 [hp_X]

in 1 mL

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 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 Bro mide (UNII: OSD78 555ZM) (Bro mide Io n - UNII:9 529 0 2IX0 6 )

Po tassium Bro mide

15 [hp_X]

in 1 mL

Ma g nesium Pho spha te, Diba sic Trihydra te (UNII: HF539 G9 L3Q) (Magnesium Catio n -

UNII:T6 V3LHY8 38 )

Magnesium Pho sphate,

Dibasic Trihydrate

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 Seed

15 [hp_X]

in 1 mL

Sa mbucus Nig ra Flo wering To p (UNII: CT0 3BSA18 U) (Sambucus Nigra Flo wering To p -

UNII:CT0 3BSA18 U)

Sambucus Nigra Flo wering

To p

15 [hp_X]

in 1 mL

Sepia O fficina lis Juice (UNII: QDL8 3WN8 C2) (Sepia Officinalis Juice -

UNII:QDL8 3WN8 C2)

Sepia Officinalis Juice

15 [hp_X]

in 1 mL

Da tura Stra mo nium (UNII: G6 W4F0 V8 Z3) (Datura Stramo nium - UNII:G6 W4F0 V8 Z3)

Datura Stramo nium

15 [hp_X]

in 1 mL

Theridio n Cura ssa vicum (UNII: 9 Z8 D3HEM8 L) (Theridio n Curassavicum -

UNII:9 Z8 D3HEM8 L)

Theridio n Curassavicum

15 [hp_X]

in 1 mL

Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS)

Zinc

15 [hp_X]

in 1 mL

Ma trica ria Recutita (UNII: G0 R4UBI2ZZ) (Matricaria Recutita - UNII:G0 R4UBI2ZZ)

Matricaria Recutita

3 [hp_X]

in 1 mL

Pa ssiflo ra Inca rna ta Flo wering To p (UNII: CLF5YFS11O) (Passiflo ra Incarnata Flo wering

To p - UNII:CLF5YFS11O)

Passiflo ra Incarnata

Flo wering To p

3 [hp_X]

in 1 mL

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

Va le ria n

3 [hp_X]

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:55714-429 9 -1

29 .57 mL in 1 BOTTLE, GLASS

2

NDC:55714-429 9 -2

59 .14 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 7/15/20 11

12/31/20 18

NERVOUSNESS - FEAR

arg. nit., bryonia, coffea cruda, cypripedium, gelsemium, hypericum, ignatia, iodium, kali brom., mag. phos., nat.

mur., nux vom., sambucus nig., sepia, stramonium,theridion, zinc. met., chamomilla, passiflora,valeriana liquid

Product Information

Product T ype

OTC ANIMAL DRUG

Ite m Code (Source )

NDC:55714-429 2

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Silver Nitra te (UNII: 9 5IT3W8 JZE) (Silver Catio n - UNII:57N7B0 K9 0 A)

Silver Nitrate

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

Ara bica Co ffee Bea n (UNII: 3SW6 78 MX72) (Arabica Co ffee Bean - UNII:3SW6 78 MX72)

Arabica Co ffee Bean

15 [hp_X]

in 1 mL

Cypripedium Pa rviflo rum Va r. Pubescens Ro o t (UNII: 21Y9 GZ1LZA) (Cypripedium

Parviflo rum Var. Pubescens Ro o t - UNII:21Y9 GZ1LZA)

Cypripedium Parviflo rum Var.

Pubescens Ro o t

15 [hp_X]

in 1 mL

Gelsemium Sempervirens Ro o t (UNII: 6 39 KR6 0 Q1Q) (Gelsemium Sempervirens Ro o t -

UNII:6 39 KR6 0 Q1Q)

Gelsemium Sempervirens

Ro o t

15 [hp_X]

in 1 mL

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

UNII:XK4IUX8 MNB)

Hypericum Perfo ratum

15 [hp_X]

in 1 mL

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 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 Bro mide (UNII: OSD78 555ZM) (Bro mide Io n - UNII:9 529 0 2IX0 6 )

Po tassium Bro mide

15 [hp_X]

in 1 mL

Ma g nesium Pho spha te, Diba sic Trihydra te (UNII: HF539 G9 L3Q) (Magnesium Catio n -

UNII:T6 V3LHY8 38 )

Magnesium Pho sphate,

Dibasic Trihydrate

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 Seed

15 [hp_X]

in 1 mL

Sa mbucus Nig ra Flo wering To p (UNII: CT0 3BSA18 U) (Sambucus Nigra Flo wering To p -

UNII:CT0 3BSA18 U)

Sambucus Nigra Flo wering

To p

15 [hp_X]

in 1 mL

Sepia O fficina lis Juice (UNII: QDL8 3WN8 C2) (Sepia Officinalis Juice -

UNII:QDL8 3WN8 C2)

Sepia Officinalis Juice

15 [hp_X]

in 1 mL

Da tura Stra mo nium (UNII: G6 W4F0 V8 Z3) (Datura Stramo nium - UNII:G6 W4F0 V8 Z3)

Datura Stramo nium

15 [hp_X]

in 1 mL

Theridio n Cura ssa vicum (UNII: 9 Z8 D3HEM8 L) (Theridio n Curassavicum -

Theridio n Curassavicum

15 [hp_X]

Newton Laboratories, Inc.

UNII:9 Z8 D3HEM8 L)

Theridio n Curassavicum

in 1 mL

Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS)

Zinc

15 [hp_X]

in 1 mL

Ma trica ria Recutita (UNII: G0 R4UBI2ZZ) (Matricaria Recutita - UNII:G0 R4UBI2ZZ)

Matricaria Recutita

6 [hp_X]

in 1 mL

Pa ssiflo ra Inca rna ta Flo wering To p (UNII: CLF5YFS11O) (Passiflo ra Incarnata Flo wering

To p - UNII:CLF5YFS11O)

Passiflo ra Incarnata

Flo wering To p

6 [hp_X]

in 1 mL

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

Va le ria n

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:55714-429 2-1

30 mL in 1 BOTTLE, GLASS

2

NDC:55714-429 2-2

50 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

Newto n Labo rato ries, Inc.

78 8 79 36 10

MANUFACTURE, API MANUFACTURE

Revised: 1/2019

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