Nervousness - Anxiety

Manufacturer: Newton Laboratories, Inc.
Effective date: 2011-03-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:05:01

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

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Nervousness - Anxiety Formulated for associated symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Aconitum nap. 15x, Ambra 15x, Anacardium orientale 15x, Arg. nit. 15x, Asafoetida 15x, Bryonia 15x, Chamomilla 15x, Cimicifuga 15x, Coffea cruda 15x, Cypripedium 15x, Gelsemium 15x, Hyoscyamus 15x, Hypericum 15x, Ignatia 15x, Kali phos. 15x, Nux vom. 15x, Sambucus nig. 15x, Strychninum 15x, Theridion 15x, Valeriana 15x, Passiflora 3x, Valeriana 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

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.

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-2245-0	2020-01-31	C162847	48780-1	9d75b9d0-2aac-f424-e053-dadaa90a57ce	Nervousness - Anxiety
55714-2245-1	2020-01-31	C162847	48780-1	9d75b9d0-2aac-f424-e053-dadaa90a57ce	Nervousness - Anxiety
55714-2245-2	2020-01-31	C162847	48780-1	9d75b9d0-2aac-f424-e053-dadaa90a57ce	Nervousness - Anxiety

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55714-2245-0	Nervousness - Anxiety	7.08 g in 1 BOTTLE, GLASS	PELLET	7.08	1
55714-2245-1	Nervousness - Anxiety	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35	1
55714-2245-2	Nervousness - Anxiety	56.7 g in 1 BOTTLE, GLASS	PELLET	56.7	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-2245	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, 3 package rows	20131015_a5e9fb1f-ab17-10cb-d2e5-af21a73461e2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
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.

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

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 table
Product NDC	Package NDC
55714-2245	55714-2245-1, 55714-2245-2, 55714-2245-0

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
Name	UNII	Kind
Aconitum Napellus	U0NQ8555JD	ACTIB
Ambergris	XTC0D02P6C	ACTIB
Semecarpus Anacardium Juice	Y0F0BU8RDU	ACTIB
Silver Nitrate	95IT3W8JZE	ACTIB
Asafetida	W9FZA51AS1	ACTIB
Bryonia Alba Root	T7J046YI2B	ACTIB
Matricaria Recutita	G0R4UBI2ZZ	ACTIB
Black Cohosh	K73E24S6X9	ACTIB
Arabica Coffee Bean	3SW678MX72	ACTIB
Cypripedium Parvifolum Root	21Y9GZ1LZA	ACTIB
Gelsemium Sempervirens Root	639KR60Q1Q	ACTIB
Hyoscyamus Niger	4WRK2153H3	ACTIB
Hypericum Perforatum	XK4IUX8MNB	ACTIB
Strychnos Ignatii Seed	1NM3M2487K	ACTIB
Potassium Phosphate, Dibasic	CI71S98N1Z	ACTIB
Strychnos Nux-vomica Seed	269XH13919	ACTIB
Sambucus Nigra Flowering Top	CT03BSA18U	ACTIB
Strychnine	H9Y79VD43J	ACTIB
Theridion Curassavicum	9Z8D3HEM8L	ACTIB
Valerian	JWF5YAW3QW	ACTIB
Passiflora Incarnata Flowering Top	CLF5YFS11O	ACTIB
Sucrose	C151H8M554	IACT

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 ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fde69292-2a85-c035-981f-45217f046f42			a5e9fb1f-ab17-10cb-d2e5-af21a73461e2	2011-03-01	Warnings	Exact identifier spl id: fde69292-2a85-c035-981f-45217f046f42 spl set id: a5e9fb1f-ab17-10cb-d2e5-af21a73461e2

Reported adverse events (FAERS/openFDA)#

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