Nervousness - Anxiety
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2011-06-01
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:05:07
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Nervousness - Anxiety Formulated for symptoms associated with generalized anxiety disorder, post-traumatic stress disorder, panic attacks and other related conditions.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 pellets orally (ages 6 to 11, give 3 pellets) as needed or as directed by a healthcare professional.
ACTIVE INGREDIENT SECTION
Aconitum nap. 20x, Ambra 20x, Anacardium orientale 20x, Arg. nit. 20x, Asafoetida 20x, Bryonia 20x, Chamomilla 20x, Cimicifuga 20x, Coffea cruda 20x, Cypripedium 20x, Gelsemium 20x, Hyoscyamus 20x, Hypericum 20x, Ignatia 20x, Kali phos. 20x, Nux vom. 20x, Sambucus nig. 20x, Strychninum 20x, Theridion 20x, Valeriana 20x, Passiflora 8x, Valeriana 8x, Passiflora 3x, Valeriana 3x.
PURPOSE SECTION
Formulated for symptoms associated with generalized anxiety disorder, post-traumatic stress disorder, panic attacks and other related conditions.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.
QUESTIONS? SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256
WARNINGS SECTION
Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.
PREGNANCY OR BREAST FEEDING SECTION
Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-4461-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-db64-f424-e053-dadaa90a57ce | Nervousness - Anxiety |
| 55714-4461-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-db64-f424-e053-dadaa90a57ce | Nervousness - Anxiety |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4461-1 | Nervousness - Anxiety | 28.35 g in 1 BOTTLE, GLASS | PELLET | 28.35 | 1 | |
| 55714-4461-2 | Nervousness - Anxiety | 56.7 g in 1 BOTTLE, GLASS | PELLET | 56.7 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-4461 | 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) PELLET [NEWTON LABORATORIES, INC.] | 1 | Legacy NDC, 2 package rows | 20131030_a9799afd-12fc-1408-0962-a183c8de5f77.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Aconitum Napellus | ACTIVE INGREDIENT | U0NQ8555JD | 1 | |
| Ambergris | ACTIVE INGREDIENT | XTC0D02P6C | 1 | |
| Arabica Coffee Bean | ACTIVE INGREDIENT | 3SW678MX72 | 1 | |
| Asafetida | ACTIVE INGREDIENT | W9FZA51AS1 | 1 | |
| Black Cohosh | ACTIVE INGREDIENT | K73E24S6X9 | 1 | |
| Bryonia Alba Root | ACTIVE INGREDIENT | T7J046YI2B | 1 | |
| Cypripedium Parvifolum Root | ACTIVE INGREDIENT | 21Y9GZ1LZA | 1 | |
| Gelsemium Sempervirens Root | ACTIVE INGREDIENT | 639KR60Q1Q | 1 | |
| Hyoscyamus Niger | ACTIVE INGREDIENT | 4WRK2153H3 | 1 | |
| Hypericum Perforatum | ACTIVE INGREDIENT | XK4IUX8MNB | 1 | |
| Matricaria Recutita | ACTIVE INGREDIENT | G0R4UBI2ZZ | 1 | |
| Passiflora Incarnata Flowering Top | ACTIVE INGREDIENT | CLF5YFS11O | 1 | |
| Potassium Phosphate, Dibasic | ACTIVE INGREDIENT | CI71S98N1Z | 1 | |
| Sambucus Nigra Flowering Top | ACTIVE INGREDIENT | CT03BSA18U | 1 | |
| Semecarpus Anacardium Juice | ACTIVE INGREDIENT | Y0F0BU8RDU | 1 | |
| Silver Nitrate | ACTIVE INGREDIENT | 95IT3W8JZE | 1 | |
| Strychnine | ACTIVE INGREDIENT | H9Y79VD43J | 1 | |
| Strychnos Ignatii Seed | ACTIVE INGREDIENT | 1NM3M2487K | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE INGREDIENT | 269XH13919 | 1 | |
| Theridion Curassavicum | ACTIVE INGREDIENT | 9Z8D3HEM8L | 1 | |
| Valerian | ACTIVE INGREDIENT | JWF5YAW3QW | 1 | |
| Aconitum Napellus | ACTIVE MOIETY | U0NQ8555JD | 1 | |
| Ambergris | ACTIVE MOIETY | XTC0D02P6C | 1 | |
| Arabica Coffee Bean | ACTIVE MOIETY | 3SW678MX72 | 1 | |
| Asafetida | ACTIVE MOIETY | W9FZA51AS1 | 1 | |
| Black Cohosh | ACTIVE MOIETY | K73E24S6X9 | 1 | |
| Bryonia Alba Root | ACTIVE MOIETY | T7J046YI2B | 1 | |
| Cypripedium Parvifolum Root | ACTIVE MOIETY | 21Y9GZ1LZA | 1 | |
| Gelsemium Sempervirens Root | ACTIVE MOIETY | 639KR60Q1Q | 1 | |
| Hyoscyamus Niger | ACTIVE MOIETY | 4WRK2153H3 | 1 | |
| Hypericum Perforatum | ACTIVE MOIETY | XK4IUX8MNB | 1 | |
| Matricaria Recutita | ACTIVE MOIETY | G0R4UBI2ZZ | 1 | |
| Passiflora Incarnata Flowering Top | ACTIVE MOIETY | CLF5YFS11O | 1 | |
| Phosphate Ion | ACTIVE MOIETY | NK08V8K8HR | 1 | |
| Sambucus Nigra Flowering Top | ACTIVE MOIETY | CT03BSA18U | 1 | |
| Semecarpus Anacardium Juice | ACTIVE MOIETY | Y0F0BU8RDU | 1 | |
| Silver Cation | ACTIVE MOIETY | 57N7B0K90A | 1 | |
| Strychnine | ACTIVE MOIETY | H9Y79VD43J | 1 | |
| Strychnos Ignatii Seed | ACTIVE MOIETY | 1NM3M2487K | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE MOIETY | 269XH13919 | 1 | |
| Theridion Curassavicum | ACTIVE MOIETY | 9Z8D3HEM8L | 1 | |
| Valerian | ACTIVE MOIETY | JWF5YAW3QW | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 |
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
- Aconitum Napellus
- Ambergris
- Semecarpus Anacardium Juice
- Silver Nitrate
- Silver Cation
- Asafetida
- Bryonia Alba Root
- Matricaria Recutita
- Black Cohosh
- Arabica Coffee Bean
- Cypripedium Parvifolum Root
- Gelsemium Sempervirens Root
- Hyoscyamus Niger
- Hypericum Perforatum
- Strychnos Ignatii Seed
- Potassium Phosphate, Dibasic
- Phosphate Ion
- Strychnos Nux-vomica Seed
- Sambucus Nigra Flowering Top
- Strychnine
- Theridion Curassavicum
- Valerian
- Passiflora Incarnata Flowering Top
- Sucrose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4461 | 55714-4461-1, 55714-4461-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Sucrose | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| Sucrose | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| Sucrose | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| Sucrose | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg |
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 |
|---|---|---|---|---|---|---|
| dfd192fe-6084-7bad-34de-94fb6210940a | a9799afd-12fc-1408-0962-a183c8de5f77 | 2011-06-01 | Warnings | dfd192fe-6084-7bad-34de-94fb6210940a a9799afd-12fc-1408-0962-a183c8de5f77 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
