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 
Newton Laboratories, Inc.

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.

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Nervousness 4783L

INDICATIONS & USAGE SECTION

Formulated for symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by moouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Passiflora incarnata 11x, Valeriana officinalis 11x, Aconitum napellus 20x, Ambra grisea 20x, Anacardium orientale 20x, Argentum nitricum 20x, Asafoetida 20x, Bryonia 20x, Chamomilla 20x, Cimicifuga racemosa 20x, Coffea cruda 20x, Cypripedium pubescens 20x, Gelsemium sempervirens 20x, Hyoscyamus niger 20x, Hypericum perforatum 20x, Ignatia amara 20x, Kali phosphoricum 20x, Nux vomica 20x, Sambucus nigra 20x, Strychninum 20x, Theridion 20x, Valeriana officinalis 20x.

OTC - PURPOSE SECTION

Formulated for symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

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: 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

package 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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-4783
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS20 [hp_X]  in 1 mL
AMBERGRIS (UNII: XTC0D02P6C) (AMBERGRIS - UNII:XTC0D02P6C) AMBERGRIS20 [hp_X]  in 1 mL
SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE20 [hp_X]  in 1 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE20 [hp_X]  in 1 mL
FERULA ASSA-FOETIDA RESIN (UNII: W9FZA51AS1) (FERULA ASSA-FOETIDA RESIN - UNII:W9FZA51AS1) FERULA ASSA-FOETIDA RESIN20 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT20 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA20 [hp_X]  in 1 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH20 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN20 [hp_X]  in 1 mL
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT - UNII:21Y9GZ1LZA) CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT20 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT20 [hp_X]  in 1 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER20 [hp_X]  in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM20 [hp_X]  in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED20 [hp_X]  in 1 mL
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE20 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED20 [hp_X]  in 1 mL
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP20 [hp_X]  in 1 mL
STRYCHNINE (UNII: H9Y79VD43J) (STRYCHNINE - UNII:H9Y79VD43J) STRYCHNINE20 [hp_X]  in 1 mL
THERIDION CURASSAVICUM (UNII: 9Z8D3HEM8L) (THERIDION CURASSAVICUM - UNII:9Z8D3HEM8L) THERIDION CURASSAVICUM20 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN20 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP11 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4783-130 mL in 1 BOTTLE, GLASS; Type 7: Separate Products Requiring Cross Labeling09/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/02/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-4783)

Revised: 12/2020
Document Id: b5abb3d5-39f4-3349-e053-2a95a90aada7
Set id: 99706ce2-d555-88ca-e053-2a95a90abb4b
Version: 2
Effective Time: 20201204
 
Newton Laboratories, Inc.