Nervousness - Anxiety

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:52

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 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

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
55714-4783-1Nervousness - Anxiety30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4783NERVOUSNESS - 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.]2Current NDC, Legacy NDC, 1 package rows20201205_99706ce2-d555-88ca-e053-2a95a90abb4b.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
55714-478355714-4783-1

Ingredients#

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

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

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 - AnxietyACONITUM 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, PASSIFLORANewton Laboratories, Inc.99706ce2-d555-88ca-e053-2a95a90abb4b2020-12-04WarningsExact identifier
ndc (package): 55714-4783-1
ndc (product): 55714-4783
ndc11 (package): 55714478301
spl id: b5abb3d5-39f4-3349-e053-2a95a90aada7
spl set id: 99706ce2-d555-88ca-e053-2a95a90abb4b

Reported adverse events (FAERS/openFDA)#

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