Label: 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

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated June 1, 2011

If you are a consumer or patient please visit this version.

  • 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

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

  • 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

    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 pellet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4613
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avicularia Avicularia (UNII: 8ZTK6T93B6) (Avicularia Avicularia - UNII:8ZTK6T93B6) Avicularia Avicularia15 [hp_X]  in 1 g
    Amanita Muscaria Var. Muscaria Fruiting Body (UNII: DIF093I037) (Amanita Muscaria Var. Muscaria Fruiting Body - UNII:DIF093I037) Amanita Muscaria Var. Muscaria Fruiting Body10 [hp_X]  in 1 g
    Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU) Causticum10 [hp_X]  in 1 g
    Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark10 [hp_X]  in 1 g
    Conium Maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371) Conium Maculatum Flowering Top10 [hp_X]  in 1 g
    Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper10 [hp_X]  in 1 g
    Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root10 [hp_X]  in 1 g
    Hyoscyamus Niger (UNII: 4WRK2153H3) (Hyoscyamus Niger - UNII:4WRK2153H3) Hyoscyamus Niger10 [hp_X]  in 1 g
    Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum10 [hp_X]  in 1 g
    Potassium Carbonate (UNII: BQN1B9B9HA) (Carbonate Ion - UNII:7UJQ5OPE7D) Potassium Carbonate10 [hp_X]  in 1 g
    Magnesium Carbonate (UNII: 0E53J927NA) (Carbonate Ion - UNII:7UJQ5OPE7D) Magnesium Carbonate10 [hp_X]  in 1 g
    Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL) Mercury10 [hp_X]  in 1 g
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed10 [hp_X]  in 1 g
    Lead (UNII: 2P299V784P) (Lead - UNII:2P299V784P) Lead10 [hp_X]  in 1 g
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf10 [hp_X]  in 1 g
    Claviceps Purpurea Sclerotium (UNII: 01G9XEA93N) (Claviceps Purpurea Sclerotium - UNII:01G9XEA93N) Claviceps Purpurea Sclerotium10 [hp_X]  in 1 g
    Strychnine (UNII: H9Y79VD43J) (Strychnine - UNII:H9Y79VD43J) Strychnine10 [hp_X]  in 1 g
    Lycosa Tarantula (UNII: 86M454L2TT) (Lycosa Tarantula - UNII:86M454L2TT) Lycosa Tarantula10 [hp_X]  in 1 g
    Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian10 [hp_X]  in 1 g
    Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus10 [hp_X]  in 1 g
    Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc10 [hp_X]  in 1 g
    Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita3 [hp_X]  in 1 g
    Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O) Passiflora Incarnata Flowering Top3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sucrose (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4613-128.35 g in 1 BOTTLE, GLASS
    2NDC:55714-4613-256.7 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-4613)