Restless Leg

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 02:05:14

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: 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.

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: 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

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
55714-4613-1	2020-01-31	C162847	48780-1	9d75b9d0-581e-f424-e053-dadaa90a57ce	Restless Leg
55714-4613-2	2020-01-31	C162847	48780-1	9d75b9d0-581e-f424-e053-dadaa90a57ce	Restless Leg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-4613-1	Restless Leg	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35		1
55714-4613-2	Restless Leg	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
55714-4613	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) PELLET [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 2 package rows	20131121_6b02dbf8-bde2-ad93-452c-3d879395f3f1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Amanita Muscaria Var. Muscaria Fruiting Body	ACTIVE INGREDIENT	DIF093I037	1
Avicularia Avicularia	ACTIVE INGREDIENT	8ZTK6T93B6	1
Causticum	ACTIVE INGREDIENT	DD5FO1WKFU	1
Cinchona Officinalis Bark	ACTIVE INGREDIENT	S003A158SB	1
Claviceps Purpurea Sclerotium	ACTIVE INGREDIENT	01G9XEA93N	1
Conium Maculatum Flowering Top	ACTIVE INGREDIENT	Q28R5GF371	1
Copper	ACTIVE INGREDIENT	789U1901C5	1
Gelsemium Sempervirens Root	ACTIVE INGREDIENT	639KR60Q1Q	1
Hyoscyamus Niger	ACTIVE INGREDIENT	4WRK2153H3	1
Hypericum Perforatum	ACTIVE INGREDIENT	XK4IUX8MNB	1
Lead	ACTIVE INGREDIENT	2P299V784P	1
Lycosa Tarantula	ACTIVE INGREDIENT	86M454L2TT	1
Magnesium Carbonate	ACTIVE INGREDIENT	0E53J927NA	1
Matricaria Recutita	ACTIVE INGREDIENT	G0R4UBI2ZZ	1
Mercury	ACTIVE INGREDIENT	FXS1BY2PGL	1
Passiflora Incarnata Flowering Top	ACTIVE INGREDIENT	CLF5YFS11O	1
Potassium Carbonate	ACTIVE INGREDIENT	BQN1B9B9HA	1
Strychnine	ACTIVE INGREDIENT	H9Y79VD43J	1
Strychnos Nux-vomica Seed	ACTIVE INGREDIENT	269XH13919	1
Toxicodendron Pubescens Leaf	ACTIVE INGREDIENT	6IO182RP7A	1
Valerian	ACTIVE INGREDIENT	JWF5YAW3QW	1
Verbascum Thapsus	ACTIVE INGREDIENT	C9TD27U172	1
Zinc	ACTIVE INGREDIENT	J41CSQ7QDS	1
Amanita Muscaria Var. Muscaria Fruiting Body	ACTIVE MOIETY	DIF093I037	1
Avicularia Avicularia	ACTIVE MOIETY	8ZTK6T93B6	1
Carbonate Ion	ACTIVE MOIETY	7UJQ5OPE7D	1
Causticum	ACTIVE MOIETY	DD5FO1WKFU	1
Cinchona Officinalis Bark	ACTIVE MOIETY	S003A158SB	1
Claviceps Purpurea Sclerotium	ACTIVE MOIETY	01G9XEA93N	1
Conium Maculatum Flowering Top	ACTIVE MOIETY	Q28R5GF371	1
Copper	ACTIVE MOIETY	789U1901C5	1
Gelsemium Sempervirens Root	ACTIVE MOIETY	639KR60Q1Q	1
Hyoscyamus Niger	ACTIVE MOIETY	4WRK2153H3	1
Hypericum Perforatum	ACTIVE MOIETY	XK4IUX8MNB	1
Lead	ACTIVE MOIETY	2P299V784P	1
Lycosa Tarantula	ACTIVE MOIETY	86M454L2TT	1
Matricaria Recutita	ACTIVE MOIETY	G0R4UBI2ZZ	1
Mercury	ACTIVE MOIETY	FXS1BY2PGL	1
Passiflora Incarnata Flowering Top	ACTIVE MOIETY	CLF5YFS11O	1
Strychnine	ACTIVE MOIETY	H9Y79VD43J	1
Strychnos Nux-vomica Seed	ACTIVE MOIETY	269XH13919	1
Toxicodendron Pubescens Leaf	ACTIVE MOIETY	6IO182RP7A	1
Valerian	ACTIVE MOIETY	JWF5YAW3QW	1
Verbascum Thapsus	ACTIVE MOIETY	C9TD27U172	1
Zinc	ACTIVE MOIETY	J41CSQ7QDS	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	1

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
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-4613	55714-4613-1, 55714-4613-2

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
Sucrose	C151H8M554	IACT

Source Document#

Source XML · Source PDF

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	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 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	CAPSULE, COATED PELLETS / ORAL	59.8 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	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 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
Sucrose	SUCROSE	C151H8M554	LIQUID / ORAL		37500 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	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 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	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 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	POWDER, FOR SUSPENSION / ORAL		40017 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	TABLET / ORAL		4249 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	SOLUTION / ORAL		70000 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	CAPSULE, DELAYED RELEASE / ORAL		955 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	INJECTION, SOLUTION / INTRAVENOUS	NA		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	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	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	SUSPENSION, EXTENDED RELEASE / ORAL		5400 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	DROPS / ORAL	NA		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	ELIXIR / ORAL		18000 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	PASTILLE / ORAL	426 mg		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	LOZENGE / BUCCAL	NA		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	INJECTION / SUBCUTANEOUS	47.75 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	SUSPENSION/ DROPS / ORAL		3750 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	WAFER / ORAL	155.2 mg		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	SYRUP / ORAL		46400 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	CAPSULE / ORAL		3568 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	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 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

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
a7de20a6-c9f7-0303-22e1-659794b081bb			6b02dbf8-bde2-ad93-452c-3d879395f3f1	2011-06-01	Warnings	Exact identifier spl id: a7de20a6-c9f7-0303-22e1-659794b081bb spl set id: 6b02dbf8-bde2-ad93-452c-3d879395f3f1

Reported adverse events (FAERS/openFDA)#

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