Restless Leg

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 02:05:28

Label at a glance#

ProductRestless Leg

Active ingredientAvicularia Avicularia, Amanita Muscaria Var. Muscaria Fruiting Body, Causticum, Cinchona Officinalis Bark, Conium Maculatum Flowering Top, Copper, Gelsemium Sempervirens Root, Hyoscyamus Niger, Hypericum Perforatum, Potassium Carbonate, Magnesium Carbonate, Mercury, Strychnos Nux-vomica Seed, Lead, Toxicodendron Pubescens Leaf, Claviceps Purpurea Sclerotium, Strychnine, Lycosa Tarantula, Valerian, Verbascum Thapsus, Zinc, Matricaria Recutita, 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

Restless Leg Formulated for symptoms associated with Restless Leg Syndrome, Parkinson's, neuroleptic~induced akathisia and other related conditions.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Mygale 15x, Agaricus musc. 10x, Causticum 10x, Cinchona 10x, Conium 10x, Cuprum met. 10x, Gelsemium 10x, Hyoscyamus 10x, Hypericum 10x, Kali carb. 10x ,Mag. carb. 10x, Merc. viv. 10x, Nux vom. 10x, Plumb. met. 10x, Rhus toxicodendron 10x, Secale 10x, Strychninum 10x, Tarentula hispana 10x, Valeriana 10x, Verbascum 10x, Zinc. met. 10x, Chamomilla 3x, Passiflora 3x, Valeriana 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms associated with Restless Leg Syndrome, Parkinson's, neuroleptic-induced akathisia 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c599c4a0-705d-4ebb-ab1f-977af038f96a	Product name	1	20251124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-4612-1	2020-01-31	C162847	48780-1	9d75b9d1-2598-f424-e053-dadaa90a57ce	Restless Leg
55714-4612-2	2020-01-31	C162847	48780-1	9d75b9d1-2598-f424-e053-dadaa90a57ce	Restless Leg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-4612-1	Restless Leg	29.57 mL in 1 BOTTLE, GLASS	LIQUID	29.57		3
55714-4612-2	Restless Leg	59.14 mL in 1 BOTTLE, GLASS	LIQUID	59.14		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-4612	RESTLESS LEG (MYGALE, AGARICUS MUSC., CAUSTICUM, CINCHONA, CONIUM, CUPRUM MET., GELSEMIUM, HYOSCYAMUS, HYPERICUM, KALI CARB, MAG.CARB, MERC. VIV., NUX VOM., PLUMB. MET., RHUS TOXICODENDRON, SECALE, STRYCHNINUM, TARENTULA HISPANA, VALERIANA, VERBASCUM, ZINC. MET., CHAMOMILLA, PASSIFLORA) LIQUID [NEWTON LABORATORIES, INC.]	3	Legacy NDC, 2 package rows	20140211_d3f2d68b-9b8f-1529-93c9-8335198ea5a9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Amanita Muscaria Var. Muscaria Fruiting Body	ACTIVE INGREDIENT	DIF093I037	3
Avicularia Avicularia	ACTIVE INGREDIENT	8ZTK6T93B6	3
Causticum	ACTIVE INGREDIENT	DD5FO1WKFU	3
Cinchona Officinalis Bark	ACTIVE INGREDIENT	S003A158SB	3
Claviceps Purpurea Sclerotium	ACTIVE INGREDIENT	01G9XEA93N	3
Conium Maculatum Flowering Top	ACTIVE INGREDIENT	Q28R5GF371	3
Copper	ACTIVE INGREDIENT	789U1901C5	3
Gelsemium Sempervirens Root	ACTIVE INGREDIENT	639KR60Q1Q	3
Hyoscyamus Niger	ACTIVE INGREDIENT	4WRK2153H3	3
Hypericum Perforatum	ACTIVE INGREDIENT	XK4IUX8MNB	3
Lead	ACTIVE INGREDIENT	2P299V784P	3
Lycosa Tarantula	ACTIVE INGREDIENT	86M454L2TT	3
Magnesium Carbonate	ACTIVE INGREDIENT	0E53J927NA	3
Matricaria Recutita	ACTIVE INGREDIENT	G0R4UBI2ZZ	3
Mercury	ACTIVE INGREDIENT	FXS1BY2PGL	3
Passiflora Incarnata Flowering Top	ACTIVE INGREDIENT	CLF5YFS11O	3
Potassium Carbonate	ACTIVE INGREDIENT	BQN1B9B9HA	3
Strychnine	ACTIVE INGREDIENT	H9Y79VD43J	3
Strychnos Nux-vomica Seed	ACTIVE INGREDIENT	269XH13919	3
Toxicodendron Pubescens Leaf	ACTIVE INGREDIENT	6IO182RP7A	3
Valerian	ACTIVE INGREDIENT	JWF5YAW3QW	3
Verbascum Thapsus	ACTIVE INGREDIENT	C9TD27U172	3
Zinc	ACTIVE INGREDIENT	J41CSQ7QDS	3
Amanita Muscaria Var. Muscaria Fruiting Body	ACTIVE MOIETY	DIF093I037	3
Avicularia Avicularia	ACTIVE MOIETY	8ZTK6T93B6	3
Carbonate Ion	ACTIVE MOIETY	7UJQ5OPE7D	3
Causticum	ACTIVE MOIETY	DD5FO1WKFU	3
Cinchona Officinalis Bark	ACTIVE MOIETY	S003A158SB	3
Claviceps Purpurea Sclerotium	ACTIVE MOIETY	01G9XEA93N	3
Conium Maculatum Flowering Top	ACTIVE MOIETY	Q28R5GF371	3
Copper	ACTIVE MOIETY	789U1901C5	3
Gelsemium Sempervirens Root	ACTIVE MOIETY	639KR60Q1Q	3
Hyoscyamus Niger	ACTIVE MOIETY	4WRK2153H3	3
Hypericum Perforatum	ACTIVE MOIETY	XK4IUX8MNB	3
Lead	ACTIVE MOIETY	2P299V784P	3
Lycosa Tarantula	ACTIVE MOIETY	86M454L2TT	3
Matricaria Recutita	ACTIVE MOIETY	G0R4UBI2ZZ	3
Mercury	ACTIVE MOIETY	FXS1BY2PGL	3
Passiflora Incarnata Flowering Top	ACTIVE MOIETY	CLF5YFS11O	3
Strychnine	ACTIVE MOIETY	H9Y79VD43J	3
Strychnos Nux-vomica Seed	ACTIVE MOIETY	269XH13919	3
Toxicodendron Pubescens Leaf	ACTIVE MOIETY	6IO182RP7A	3
Valerian	ACTIVE MOIETY	JWF5YAW3QW	3
Verbascum Thapsus	ACTIVE MOIETY	C9TD27U172	3
Zinc	ACTIVE MOIETY	J41CSQ7QDS	3
Alcohol	INACTIVE INGREDIENT	3K9958V90M	3

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

Restless Leg
Mygale, Agaricus musc., Causticum, Cinchona, Conium, Cuprum met., Gelsemium, Hyoscyamus, Hypericum, Kali carb, Mag.carb, Merc. viv., Nux vom., Plumb. met., Rhus toxicodendron, Secale, Strychninum, Tarentula hispana, Valeriana, Verbascum, Zinc. met., Chamomilla, Passiflora
Avicularia Avicularia
Amanita Muscaria Var. Muscaria Fruiting Body
Causticum
Cinchona Officinalis Bark
Conium Maculatum Flowering Top
Copper
Gelsemium Sempervirens Root
Hyoscyamus Niger
Hypericum Perforatum
Potassium Carbonate
Carbonate Ion
Magnesium Carbonate
Mercury
Strychnos Nux-vomica Seed
Lead
Toxicodendron Pubescens Leaf
Claviceps Purpurea Sclerotium
Strychnine
Lycosa Tarantula
Valerian
Verbascum Thapsus
Zinc
Matricaria Recutita
Passiflora Incarnata Flowering Top
Alcohol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-4612	55714-4612-1, 55714-4612-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Avicularia Avicularia	8ZTK6T93B6	ACTIB
Amanita Muscaria Var. Muscaria Fruiting Body	DIF093I037	ACTIB
Causticum	DD5FO1WKFU	ACTIB
Cinchona Officinalis Bark	S003A158SB	ACTIB
Conium Maculatum Flowering Top	Q28R5GF371	ACTIB
Copper	789U1901C5	ACTIB
Gelsemium Sempervirens Root	639KR60Q1Q	ACTIB
Hyoscyamus Niger	4WRK2153H3	ACTIB
Hypericum Perforatum	XK4IUX8MNB	ACTIB
Potassium Carbonate	BQN1B9B9HA	ACTIB
Magnesium Carbonate	0E53J927NA	ACTIB
Mercury	FXS1BY2PGL	ACTIB
Strychnos Nux-vomica Seed	269XH13919	ACTIB
Lead	2P299V784P	ACTIB
Toxicodendron Pubescens Leaf	6IO182RP7A	ACTIB
Claviceps Purpurea Sclerotium	01G9XEA93N	ACTIB
Strychnine	H9Y79VD43J	ACTIB
Lycosa Tarantula	86M454L2TT	ACTIB
Valerian	JWF5YAW3QW	ACTIB
Verbascum Thapsus	C9TD27U172	ACTIB
Zinc	J41CSQ7QDS	ACTIB
Matricaria Recutita	G0R4UBI2ZZ	ACTIB
Passiflora Incarnata Flowering Top	CLF5YFS11O	ACTIB
Alcohol	3K9958V90M	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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Alcohol	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / DENTAL	12.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	CONCENTRATE / BUCCAL	679 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / SUBCUTANEOUS	6.1 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY, METERED / SUBLINGUAL		29 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / INTRAVENOUS		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d062da5b-fd1c-a3a2-56b1-bad8a3c5838b			d3f2d68b-9b8f-1529-93c9-8335198ea5a9	2011-06-01	Warnings	Exact identifier spl id: d062da5b-fd1c-a3a2-56b1-bad8a3c5838b spl set id: d3f2d68b-9b8f-1529-93c9-8335198ea5a9

Reported adverse events (FAERS/openFDA)#

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