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
- NDC Code(s): 55714-4292-1, 55714-4299-1, 55714-4299-2
- Packager: Newton Laboratories, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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Drug Label Information
Updated January 14, 2019
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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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
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
- WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL.PRINCIPAL
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INGREDIENTS AND APPEARANCE
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 liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:55714-4299 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate 15 [hp_X] in 1 mL Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 15 [hp_X] in 1 mL Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72) Arabica Coffee Bean 15 [hp_X] in 1 mL Cypripedium Parviflorum Var. Pubescens Root (UNII: 21Y9GZ1LZA) (Cypripedium Parviflorum Var. Pubescens Root - UNII:21Y9GZ1LZA) Cypripedium Parviflorum Var. Pubescens Root 15 [hp_X] in 1 mL Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 15 [hp_X] in 1 mL Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum 15 [hp_X] in 1 mL Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K) Strychnos Ignatii Seed 15 [hp_X] in 1 mL Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine 15 [hp_X] in 1 mL Potassium Bromide (UNII: OSD78555ZM) (Bromide Ion - UNII:952902IX06) Potassium Bromide 15 [hp_X] in 1 mL Magnesium Phosphate, Dibasic Trihydrate (UNII: HF539G9L3Q) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Phosphate, Dibasic Trihydrate 15 [hp_X] in 1 mL Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride 15 [hp_X] in 1 mL Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed 15 [hp_X] in 1 mL Sambucus Nigra Flowering Top (UNII: CT03BSA18U) (Sambucus Nigra Flowering Top - UNII:CT03BSA18U) Sambucus Nigra Flowering Top 15 [hp_X] in 1 mL Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice 15 [hp_X] in 1 mL Datura Stramonium (UNII: G6W4F0V8Z3) (Datura Stramonium - UNII:G6W4F0V8Z3) Datura Stramonium 15 [hp_X] in 1 mL Theridion Curassavicum (UNII: 9Z8D3HEM8L) (Theridion Curassavicum - UNII:9Z8D3HEM8L) Theridion Curassavicum 15 [hp_X] in 1 mL Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc 15 [hp_X] in 1 mL Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita 3 [hp_X] in 1 mL Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O) Passiflora Incarnata Flowering Top 3 [hp_X] in 1 mL Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian 3 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4299-1 29.57 mL in 1 BOTTLE, GLASS 2 NDC:55714-4299-2 59.14 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/15/2011 12/31/2018 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 liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:55714-4292 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate 15 [hp_X] in 1 mL Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 15 [hp_X] in 1 mL Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72) Arabica Coffee Bean 15 [hp_X] in 1 mL Cypripedium Parviflorum Var. Pubescens Root (UNII: 21Y9GZ1LZA) (Cypripedium Parviflorum Var. Pubescens Root - UNII:21Y9GZ1LZA) Cypripedium Parviflorum Var. Pubescens Root 15 [hp_X] in 1 mL Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 15 [hp_X] in 1 mL Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum 15 [hp_X] in 1 mL Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K) Strychnos Ignatii Seed 15 [hp_X] in 1 mL Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine 15 [hp_X] in 1 mL Potassium Bromide (UNII: OSD78555ZM) (Bromide Ion - UNII:952902IX06) Potassium Bromide 15 [hp_X] in 1 mL Magnesium Phosphate, Dibasic Trihydrate (UNII: HF539G9L3Q) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Phosphate, Dibasic Trihydrate 15 [hp_X] in 1 mL Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride 15 [hp_X] in 1 mL Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed 15 [hp_X] in 1 mL Sambucus Nigra Flowering Top (UNII: CT03BSA18U) (Sambucus Nigra Flowering Top - UNII:CT03BSA18U) Sambucus Nigra Flowering Top 15 [hp_X] in 1 mL Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice 15 [hp_X] in 1 mL Datura Stramonium (UNII: G6W4F0V8Z3) (Datura Stramonium - UNII:G6W4F0V8Z3) Datura Stramonium 15 [hp_X] in 1 mL Theridion Curassavicum (UNII: 9Z8D3HEM8L) (Theridion Curassavicum - UNII:9Z8D3HEM8L) Theridion Curassavicum 15 [hp_X] in 1 mL Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc 15 [hp_X] in 1 mL Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita 6 [hp_X] in 1 mL Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O) Passiflora Incarnata Flowering Top 6 [hp_X] in 1 mL Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4292-1 30 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/14/2019 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE, API MANUFACTURE