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Restless Leg (Newton Laboratories, Inc.)

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LIQUID 29.57 mL in 1 BOTTLE, GLASS (55714-4612-1) Label Information

Complete Restless Leg 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

    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

    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)