FDA.reportPublic FDA data

Nervousness - Anxiety

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:05:26

Label at a glance#

ProductNervousness - Anxiety
Active ingredientAconitum Napellus, Ambergris, Semecarpus Anacardium Juice, Silver Nitrate, 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, 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

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

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.   Ages 12 and up, take 6 drops orally (ages 6 to 11, give 3 drops) as needed or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

OTC - 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

ABUSE SECTION

Formulated for symptoms associated with generalized anxiety disorder, post-traumatic stress disorder, panic attacks and other related conditions.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

QUESTIONS? SECTION

OTC - 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

OTC - 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label
Package 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4460-12020-01-31C16284748780-19d75b9d0-49a5-f424-e053-dadaa90a57ceNervousness - Anxiety
55714-4460-22020-01-31C16284748780-19d75b9d0-49a5-f424-e053-dadaa90a57ceNervousness - Anxiety

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4460-1Nervousness - Anxiety29.57 mL in 1 BOTTLE, GLASSLIQUID29.573
55714-4460-2Nervousness - Anxiety59.14 mL in 1 BOTTLE, GLASSLIQUID59.143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4460NERVOUSNESS - 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.]3Legacy NDC, 2 package rows20140206_4db6e74a-ca03-d7b7-d697-78225ea38d5e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD3
AmbergrisACTIVE INGREDIENTXTC0D02P6C3
Arabica Coffee BeanACTIVE INGREDIENT3SW678MX723
AsafetidaACTIVE INGREDIENTW9FZA51AS13
Black CohoshACTIVE INGREDIENTK73E24S6X93
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B3
Cypripedium Parvifolum RootACTIVE INGREDIENT21Y9GZ1LZA3
Gelsemium Sempervirens RootACTIVE INGREDIENT639KR60Q1Q3
Hyoscyamus NigerACTIVE INGREDIENT4WRK2153H33
Hypericum PerforatumACTIVE INGREDIENTXK4IUX8MNB3
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ3
Passiflora Incarnata Flowering TopACTIVE INGREDIENTCLF5YFS11O3
Potassium Phosphate, DibasicACTIVE INGREDIENTCI71S98N1Z3
Sambucus Nigra Flowering TopACTIVE INGREDIENTCT03BSA18U3
Semecarpus Anacardium JuiceACTIVE INGREDIENTY0F0BU8RDU3
Silver NitrateACTIVE INGREDIENT95IT3W8JZE3
StrychnineACTIVE INGREDIENTH9Y79VD43J3
Strychnos Ignatii SeedACTIVE INGREDIENT1NM3M2487K3
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139193
Theridion CurassavicumACTIVE INGREDIENT9Z8D3HEM8L3
ValerianACTIVE INGREDIENTJWF5YAW3QW3
Aconitum NapellusACTIVE MOIETYU0NQ8555JD3
AmbergrisACTIVE MOIETYXTC0D02P6C3
Arabica Coffee BeanACTIVE MOIETY3SW678MX723
AsafetidaACTIVE MOIETYW9FZA51AS13
Black CohoshACTIVE MOIETYK73E24S6X93
Bryonia Alba RootACTIVE MOIETYT7J046YI2B3
Cypripedium Parvifolum RootACTIVE MOIETY21Y9GZ1LZA3
Gelsemium Sempervirens RootACTIVE MOIETY639KR60Q1Q3
Hyoscyamus NigerACTIVE MOIETY4WRK2153H33
Hypericum PerforatumACTIVE MOIETYXK4IUX8MNB3
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ3
Passiflora Incarnata Flowering TopACTIVE MOIETYCLF5YFS11O3
Phosphate IonACTIVE MOIETYNK08V8K8HR3
Sambucus Nigra Flowering TopACTIVE MOIETYCT03BSA18U3
Semecarpus Anacardium JuiceACTIVE MOIETYY0F0BU8RDU3
Silver CationACTIVE MOIETY57N7B0K90A3
StrychnineACTIVE MOIETYH9Y79VD43J3
Strychnos Ignatii SeedACTIVE MOIETY1NM3M2487K3
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139193
Theridion CurassavicumACTIVE MOIETY9Z8D3HEM8L3
ValerianACTIVE MOIETYJWF5YAW3QW3
AlcoholINACTIVE INGREDIENT3K9958V90M3

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-446055714-4460-1, 55714-4460-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
Aconitum NapellusU0NQ8555JDACTIB
AmbergrisXTC0D02P6CACTIB
Semecarpus Anacardium JuiceY0F0BU8RDUACTIB
Silver Nitrate95IT3W8JZEACTIB
AsafetidaW9FZA51AS1ACTIB
Bryonia Alba RootT7J046YI2BACTIB
Matricaria RecutitaG0R4UBI2ZZACTIB
Black CohoshK73E24S6X9ACTIB
Arabica Coffee Bean3SW678MX72ACTIB
Cypripedium Parvifolum Root21Y9GZ1LZAACTIB
Gelsemium Sempervirens Root639KR60Q1QACTIB
Hyoscyamus Niger4WRK2153H3ACTIB
Hypericum PerforatumXK4IUX8MNBACTIB
Strychnos Ignatii Seed1NM3M2487KACTIB
Potassium Phosphate, DibasicCI71S98N1ZACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Sambucus Nigra Flowering TopCT03BSA18UACTIB
StrychnineH9Y79VD43JACTIB
Theridion Curassavicum9Z8D3HEM8LACTIB
ValerianJWF5YAW3QWACTIB
Passiflora Incarnata Flowering TopCLF5YFS11OACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
359be9b3-5733-bb89-dedc-2a54969a367a4db6e74a-ca03-d7b7-d697-78225ea38d5e2011-06-01WarningsExact identifier
spl id: 359be9b3-5733-bb89-dedc-2a54969a367a
spl set id: 4db6e74a-ca03-d7b7-d697-78225ea38d5e

Reported adverse events (FAERS/openFDA)#

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