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

package label
package label

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 TypeOTC ANIMAL DRUGItem Code (Source)NDC:55714-4299
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate15 [hp_X]  in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72) Arabica Coffee Bean15 [hp_X]  in 1 mL
Cypripedium Parviflorum Var. Pubescens Root (UNII: 21Y9GZ1LZA) (Cypripedium Parviflorum Var. Pubescens Root - UNII:21Y9GZ1LZA) Cypripedium Parviflorum Var. Pubescens Root15 [hp_X]  in 1 mL
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root15 [hp_X]  in 1 mL
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum15 [hp_X]  in 1 mL
Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K) Strychnos Ignatii Seed15 [hp_X]  in 1 mL
Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine15 [hp_X]  in 1 mL
Potassium Bromide (UNII: OSD78555ZM) (Bromide Ion - UNII:952902IX06) Potassium Bromide15 [hp_X]  in 1 mL
Magnesium Phosphate, Dibasic Trihydrate (UNII: HF539G9L3Q) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Phosphate, Dibasic Trihydrate15 [hp_X]  in 1 mL
Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride15 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
Sambucus Nigra Flowering Top (UNII: CT03BSA18U) (Sambucus Nigra Flowering Top - UNII:CT03BSA18U) Sambucus Nigra Flowering Top15 [hp_X]  in 1 mL
Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice15 [hp_X]  in 1 mL
Datura Stramonium (UNII: G6W4F0V8Z3) (Datura Stramonium - UNII:G6W4F0V8Z3) Datura Stramonium15 [hp_X]  in 1 mL
Theridion Curassavicum (UNII: 9Z8D3HEM8L) (Theridion Curassavicum - UNII:9Z8D3HEM8L) Theridion Curassavicum15 [hp_X]  in 1 mL
Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc15 [hp_X]  in 1 mL
Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita3 [hp_X]  in 1 mL
Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O) Passiflora Incarnata Flowering Top3 [hp_X]  in 1 mL
Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4299-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-4299-259.14 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/15/201112/31/2018
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 TypeOTC ANIMAL DRUGItem Code (Source)NDC:55714-4292
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate15 [hp_X]  in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72) Arabica Coffee Bean15 [hp_X]  in 1 mL
Cypripedium Parviflorum Var. Pubescens Root (UNII: 21Y9GZ1LZA) (Cypripedium Parviflorum Var. Pubescens Root - UNII:21Y9GZ1LZA) Cypripedium Parviflorum Var. Pubescens Root15 [hp_X]  in 1 mL
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root15 [hp_X]  in 1 mL
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum15 [hp_X]  in 1 mL
Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K) Strychnos Ignatii Seed15 [hp_X]  in 1 mL
Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine15 [hp_X]  in 1 mL
Potassium Bromide (UNII: OSD78555ZM) (Bromide Ion - UNII:952902IX06) Potassium Bromide15 [hp_X]  in 1 mL
Magnesium Phosphate, Dibasic Trihydrate (UNII: HF539G9L3Q) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Phosphate, Dibasic Trihydrate15 [hp_X]  in 1 mL
Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride15 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
Sambucus Nigra Flowering Top (UNII: CT03BSA18U) (Sambucus Nigra Flowering Top - UNII:CT03BSA18U) Sambucus Nigra Flowering Top15 [hp_X]  in 1 mL
Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice15 [hp_X]  in 1 mL
Datura Stramonium (UNII: G6W4F0V8Z3) (Datura Stramonium - UNII:G6W4F0V8Z3) Datura Stramonium15 [hp_X]  in 1 mL
Theridion Curassavicum (UNII: 9Z8D3HEM8L) (Theridion Curassavicum - UNII:9Z8D3HEM8L) Theridion Curassavicum15 [hp_X]  in 1 mL
Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc15 [hp_X]  in 1 mL
Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita6 [hp_X]  in 1 mL
Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O) Passiflora Incarnata Flowering Top6 [hp_X]  in 1 mL
Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4292-130 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/14/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE, API MANUFACTURE

Revised: 1/2019
Document Id: f7757cba-3157-4193-8053-c8143d6f50b7
Set id: b5fa7686-2473-ea0c-4237-5cb619d64dea
Version: 5
Effective Time: 20190114
 
Newton Laboratories, Inc.