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#

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:  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

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: Gluten-free, non-GMO, beet-derived sucrose pellets.

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
55714-4461-12020-01-31C16284748780-19d75b9d0-db64-f424-e053-dadaa90a57ceNervousness - Anxiety
55714-4461-22020-01-31C16284748780-19d75b9d0-db64-f424-e053-dadaa90a57ceNervousness - Anxiety

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4461-1Nervousness - Anxiety28.35 g in 1 BOTTLE, GLASSPELLET28.351
55714-4461-2Nervousness - Anxiety56.7 g in 1 BOTTLE, GLASSPELLET56.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4461NERVOUSNESS - 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.]1Legacy NDC, 2 package rows20131030_a9799afd-12fc-1408-0962-a183c8de5f77.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD1
AmbergrisACTIVE INGREDIENTXTC0D02P6C1
Arabica Coffee BeanACTIVE INGREDIENT3SW678MX721
AsafetidaACTIVE INGREDIENTW9FZA51AS11
Black CohoshACTIVE INGREDIENTK73E24S6X91
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Cypripedium Parvifolum RootACTIVE INGREDIENT21Y9GZ1LZA1
Gelsemium Sempervirens RootACTIVE INGREDIENT639KR60Q1Q1
Hyoscyamus NigerACTIVE INGREDIENT4WRK2153H31
Hypericum PerforatumACTIVE INGREDIENTXK4IUX8MNB1
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ1
Passiflora Incarnata Flowering TopACTIVE INGREDIENTCLF5YFS11O1
Potassium Phosphate, DibasicACTIVE INGREDIENTCI71S98N1Z1
Sambucus Nigra Flowering TopACTIVE INGREDIENTCT03BSA18U1
Semecarpus Anacardium JuiceACTIVE INGREDIENTY0F0BU8RDU1
Silver NitrateACTIVE INGREDIENT95IT3W8JZE1
StrychnineACTIVE INGREDIENTH9Y79VD43J1
Strychnos Ignatii SeedACTIVE INGREDIENT1NM3M2487K1
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Theridion CurassavicumACTIVE INGREDIENT9Z8D3HEM8L1
ValerianACTIVE INGREDIENTJWF5YAW3QW1
Aconitum NapellusACTIVE MOIETYU0NQ8555JD1
AmbergrisACTIVE MOIETYXTC0D02P6C1
Arabica Coffee BeanACTIVE MOIETY3SW678MX721
AsafetidaACTIVE MOIETYW9FZA51AS11
Black CohoshACTIVE MOIETYK73E24S6X91
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Cypripedium Parvifolum RootACTIVE MOIETY21Y9GZ1LZA1
Gelsemium Sempervirens RootACTIVE MOIETY639KR60Q1Q1
Hyoscyamus NigerACTIVE MOIETY4WRK2153H31
Hypericum PerforatumACTIVE MOIETYXK4IUX8MNB1
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ1
Passiflora Incarnata Flowering TopACTIVE MOIETYCLF5YFS11O1
Phosphate IonACTIVE MOIETYNK08V8K8HR1
Sambucus Nigra Flowering TopACTIVE MOIETYCT03BSA18U1
Semecarpus Anacardium JuiceACTIVE MOIETYY0F0BU8RDU1
Silver CationACTIVE MOIETY57N7B0K90A1
StrychnineACTIVE MOIETYH9Y79VD43J1
Strychnos Ignatii SeedACTIVE MOIETY1NM3M2487K1
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Theridion CurassavicumACTIVE MOIETY9Z8D3HEM8L1
ValerianACTIVE MOIETYJWF5YAW3QW1
SucroseINACTIVE INGREDIENTC151H8M5541

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
55714-446155714-4461-1, 55714-4461-2

Ingredients#

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

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

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 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SucroseSUCROSEC151H8M554INJECTION, EMULSION / INTRAVENOUS970 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, FILM COATED, EXTENDED RELEASE / ORAL119.12 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TROCHE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS308 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554LOZENGE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS900 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTION / SUBCUTANEOUS47.75 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554POWDER / ORAL27768 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554INJECTABLE, LIPOSOMAL / INTRAVENOUS7560 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
SucroseSUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii candidate
48 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
dfd192fe-6084-7bad-34de-94fb6210940aa9799afd-12fc-1408-0962-a183c8de5f772011-06-01WarningsExact identifier
spl id: dfd192fe-6084-7bad-34de-94fb6210940a
spl set id: a9799afd-12fc-1408-0962-a183c8de5f77

Reported adverse events (FAERS/openFDA)#

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