Label: NERVOUSNESS - ANXIETY- aconitum nap., ambra, anacardium orientale, arg. nit., asafoetida, bryonia, chamomilla, cimicifuga, coffea cruda, cypripedium, gelsemium, hyoscyamus, hypericum, ignatia, kali phos., nux vom., sambucus nig., strychninum, theridion, valeriana, passiflora liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-2244-0, 55714-2244-1, 55714-2244-2 - Packager: Newton Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated March 1, 2011
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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OTC - ACTIVE INGREDIENT SECTION
Aconitum nap. 15x, Ambra 15x, Anacardium orientale 15x, Arg. nit. 15x, Asafoetida 15x, Bryonia 15x, Chamomilla 15x, Cimicifuga 15x, Coffea cruda 15x, Cypripedium 15x, Gelsemium 15x, Hyoscyamus 15x, Hypericum 15x, Ignatia 15x, Kali phos. 15x, Nux vom. 15x, Sambucus nig. 15x, Strychninum 15x, Theridion 15x, Valeriana 15x, Passiflora 3x, Valeriana 3x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
NERVOUSNESS - ANXIETY
aconitum nap., ambra, anacardium orientale, arg. nit., asafoetida, bryonia, chamomilla, cimicifuga, coffea cruda, cypripedium, gelsemium, hyoscyamus, hypericum, ignatia, kali phos., nux vom., sambucus nig., strychninum, theridion, valeriana, passiflora liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2244 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus 15 [hp_X] in 1 mL Ambergris (UNII: XTC0D02P6C) (Ambergris - UNII:XTC0D02P6C) Ambergris 15 [hp_X] in 1 mL Semecarpus Anacardium Juice (UNII: Y0F0BU8RDU) (Semecarpus Anacardium Juice - UNII:Y0F0BU8RDU) Semecarpus Anacardium Juice 15 [hp_X] in 1 mL Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate 15 [hp_X] in 1 mL Asafetida (UNII: W9FZA51AS1) (Asafetida - UNII:W9FZA51AS1) Asafetida 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 Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita 15 [hp_X] in 1 mL Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9) Black Cohosh 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 Parvifolum Root (UNII: 21Y9GZ1LZA) (Cypripedium Parvifolum Root - UNII:21Y9GZ1LZA) Cypripedium Parvifolum 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 Hyoscyamus Niger (UNII: 4WRK2153H3) (Hyoscyamus Niger - UNII:4WRK2153H3) Hyoscyamus Niger 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 Potassium Phosphate, Dibasic (UNII: CI71S98N1Z) (Phosphate Ion - UNII:NK08V8K8HR) Potassium Phosphate, Dibasic 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 Strychnine (UNII: H9Y79VD43J) (Strychnine - UNII:H9Y79VD43J) Strychnine 15 [hp_X] in 1 mL Theridion Curassavicum (UNII: 9Z8D3HEM8L) (Theridion Curassavicum - UNII:9Z8D3HEM8L) Theridion Curassavicum 15 [hp_X] in 1 mL Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian 15 [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 Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-2244-1 29.57 mL in 1 BOTTLE, GLASS 2 NDC:55714-2244-2 59.14 mL in 1 BOTTLE, GLASS 3 NDC:55714-2244-0 .5 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-2244)