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#
Contacts and useful links#
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
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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| efd58dcf-540a-4531-8766-e713129ca6f2 | Product name | 1 | 20250307 |
| 4b7700e3-6e0e-45e5-9d22-6f754d61386e | Product name | 2 | 20250304 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| 6cca4355-1206-91f7-02de-17eef38a8622 | Product name | 1 | 20140508 |
| 751c581a-bf64-2fd7-b3ec-ca02c83e4a00 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4783-1 | Nervousness - Anxiety | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-4783 | 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.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20201205_99706ce2-d555-88ca-e053-2a95a90abb4b.zip |
Products#
Every source-derived product name is available through these pages.
- 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
- WATER
- ALCOHOL
- ACONITUM NAPELLUS
- AMBERGRIS
- SEMECARPUS ANACARDIUM JUICE
- SILVER NITRATE
- SILVER CATION
- 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
- PHOSPHATE ION
- STRYCHNOS NUX-VOMICA SEED
- SAMBUCUS NIGRA FLOWERING TOP
- STRYCHNINE
- THERIDION CURASSAVICUM
- VALERIAN
- PASSIFLORA INCARNATA FLOWERING TOP
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4783 | 55714-4783-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 | Newton Laboratories, Inc. | 99706ce2-d555-88ca-e053-2a95a90abb4b | 2020-12-04 | Warnings | 55714-4783-1 55714-4783 55714478301 b5abb3d5-39f4-3349-e053-2a95a90aada7 99706ce2-d555-88ca-e053-2a95a90abb4b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
