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

Restless Leg by

Drug Labeling and Warnings

Restless Leg by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

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

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

Keep out of reach of children

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 55714-4612
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avicularia Avicularia (UNII: 8ZTK6T93B6) (Avicularia Avicularia - UNII:8ZTK6T93B6)	Avicularia Avicularia	15 [hp_X]  in 1 mL
Amanita Muscaria Var. Muscaria Fruiting Body (UNII: DIF093I037) (Amanita Muscaria Var. Muscaria Fruiting Body - UNII:DIF093I037)	Amanita Muscaria Var. Muscaria Fruiting Body	10 [hp_X]  in 1 mL
Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU)	Causticum	10 [hp_X]  in 1 mL
Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB)	Cinchona Officinalis Bark	10 [hp_X]  in 1 mL
Conium Maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371)	Conium Maculatum Flowering Top	10 [hp_X]  in 1 mL
Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5)	Copper	10 [hp_X]  in 1 mL
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q)	Gelsemium Sempervirens Root	10 [hp_X]  in 1 mL
Hyoscyamus Niger (UNII: 4WRK2153H3) (Hyoscyamus Niger - UNII:4WRK2153H3)	Hyoscyamus Niger	10 [hp_X]  in 1 mL
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB)	Hypericum Perforatum	10 [hp_X]  in 1 mL
Potassium Carbonate (UNII: BQN1B9B9HA) (Carbonate Ion - UNII:7UJQ5OPE7D)	Potassium Carbonate	10 [hp_X]  in 1 mL
Magnesium Carbonate (UNII: 0E53J927NA) (Carbonate Ion - UNII:7UJQ5OPE7D)	Magnesium Carbonate	10 [hp_X]  in 1 mL
Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL)	Mercury	10 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919)	Strychnos Nux-vomica Seed	10 [hp_X]  in 1 mL
Lead (UNII: 2P299V784P) (Lead - UNII:2P299V784P)	Lead	10 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A)	Toxicodendron Pubescens Leaf	10 [hp_X]  in 1 mL
Claviceps Purpurea Sclerotium (UNII: 01G9XEA93N) (Claviceps Purpurea Sclerotium - UNII:01G9XEA93N)	Claviceps Purpurea Sclerotium	10 [hp_X]  in 1 mL
Strychnine (UNII: H9Y79VD43J) (Strychnine - UNII:H9Y79VD43J)	Strychnine	10 [hp_X]  in 1 mL
Lycosa Tarantula (UNII: 86M454L2TT) (Lycosa Tarantula - UNII:86M454L2TT)	Lycosa Tarantula	10 [hp_X]  in 1 mL
Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW)	Valerian	10 [hp_X]  in 1 mL
Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172)	Verbascum Thapsus	10 [hp_X]  in 1 mL
Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS)	Zinc	10 [hp_X]  in 1 mL
Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ)	Matricaria Recutita	3 [hp_X]  in 1 mL
Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O)	Passiflora Incarnata Flowering Top	3 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-4612-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC: 55714-4612-2	59.14 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-4612)