FDA.reportPublic FDA data

Nervousness - Anxiety

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:52

Label at a glance#

ProductNervousness - Anxiety
Active ingredientACONITUM NAPELLUS, AMBERGRIS, SEMECARPUS ANACARDIUM JUICE, SILVER NITRATE, FERULA ASSA-FOETIDA RESIN, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, BLACK COHOSH, ARABICA COFFEE BEAN, CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, HYPERICUM PERFORATUM, STRYCHNOS IGNATII SEED, DIBASIC POTASSIUM PHOSPHATE, STRYCHNOS NUX-VOMICA SEED, SAMBUCUS NIGRA FLOWERING TOP, STRYCHNINE, THERIDION CURASSAVICUM, VALERIAN, PASSIFLORA INCARNATA FLOWERING TOP
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Passiflora incarnata 6x, Valeriana officinalis 6x, Aconitum napellus 15x, Ambra grisea 15x, Anacardium orientale 15x, Argentum nitricum 15x, Asafoetida 15x, Bryonia 15x, Chamomilla 15x, Cimicifuga racemosa 15x, Coffea cruda 15x, Cypripedium pubescens 15x, Gelsemium sempervirens 15x, Hyoscyamus niger 15x, Hypericum perforatum 15x, Ignatia amara 15x, Kali phosphoricum 15x, Nux vomica 15x, Sambucus nigra 15x, Strychninum 15x, Theridion 15x, Valeriana officinalis 15x.

OTC - PURPOSE SECTION

Formulated for associated 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

OTC - 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.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2491-1Nervousness - Anxiety30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2491NERVOUSNESS - ANXIETY (PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, AMBRA GRISEA, ANACARDIUM ORIENTALE, ARGENTUM NITRICUM, ASAFOETIDA, BRYONIA, CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, HYPERICUM PERFORATUM, IGNATIA AMARA, KALI PHOSPHORICUM, NUX VOMICA, SAMBUCUS NIGRA, STRYCHNINUM, THERIDION, VALERIANA OFFICINALIS.) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250210_9c5db752-11bb-01c0-e053-2a95a90aa731.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-249155714-2491-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACONITUM NAPELLUSU0NQ8555JDACTIB
AMBERGRISXTC0D02P6CACTIB
SEMECARPUS ANACARDIUM JUICEY0F0BU8RDUACTIB
SILVER NITRATE95IT3W8JZEACTIB
FERULA ASSA-FOETIDA RESINW9FZA51AS1ACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
BLACK COHOSHK73E24S6X9ACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT21Y9GZ1LZAACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
HYOSCYAMUS NIGER4WRK2153H3ACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
ALCOHOL3K9958V90MIACT
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
STRYCHNINEH9Y79VD43JACTIB
THERIDION CURASSAVICUM9Z8D3HEM8LACTIB
VALERIANJWF5YAW3QWACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nervousness - AnxietyPASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, AMBRA GRISEA, ANACARDIUM ORIENTALE, ARGENTUM NITRICUM, ASAFOETIDA, BRYONIA, CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, HYPERICUM PERFORATUM, IGNATIA AMARA, KALI PHOSPHORICUM, NUX VOMICA, SAMBUCUS NIGRA, STRYCHNINUM, THERIDION, VALERIANA OFFICINALIS.Newton Laboratories, Inc.9c5db752-11bb-01c0-e053-2a95a90aa7312025-02-07WarningsExact identifier
ndc (package): 55714-2491-1
ndc (product): 55714-2491
ndc11 (package): 55714249101
spl id: 2d952380-5840-5edf-e063-6394a90aecf4
spl set id: 9c5db752-11bb-01c0-e053-2a95a90aa731

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.