Label: NERVOUSNESS - ANXIETY- aconitum nap., ambra, anacardium orientale, arg. nit., asafoetida, bryonia, chamomilla, cimicifuga, coffea cruda, cypripedium, gelsemium, hyoscyamus, hypericum, ignatia, kali phos., nux vom., sambucus nig., strychninum, theridion, valeriana, passiflora liquid

  • Category: HUMAN OTC 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 March 1, 2011

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  • INDICATIONS & USAGE SECTION

    Nervousness - Anxiety  Formulated for associated symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

  • 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. Sensitive persons begin with 1 drop and gradually increase to full dose.

  • OTC - ACTIVE INGREDIENT SECTION

    Aconitum nap. 15x, Ambra 15x, Anacardium orientale 15x, Arg. nit. 15x, Asafoetida 15x, Bryonia 15x, Chamomilla 15x, Cimicifuga 15x, Coffea cruda 15x, Cypripedium 15x, Gelsemium 15x, Hyoscyamus 15x, Hypericum 15x, Ignatia 15x, Kali phos. 15x, Nux vom. 15x, Sambucus nig. 15x, Strychninum 15x, Theridion 15x, Valeriana 15x, Passiflora 3x, Valeriana 3x.

  • OTC - PURPOSE SECTION

    Formulated for associated symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

  • 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.  

  • 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. 

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    package label

  • INGREDIENTS AND APPEARANCE
    NERVOUSNESS - ANXIETY  
    aconitum nap., ambra, anacardium orientale, arg. nit., asafoetida, bryonia, chamomilla, cimicifuga, coffea cruda, cypripedium, gelsemium, hyoscyamus, hypericum, ignatia, kali phos., nux vom., sambucus nig., strychninum, theridion, valeriana, passiflora liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2244
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus15 [hp_X]  in 1 mL
    Ambergris (UNII: XTC0D02P6C) (Ambergris - UNII:XTC0D02P6C) Ambergris15 [hp_X]  in 1 mL
    Semecarpus Anacardium Juice (UNII: Y0F0BU8RDU) (Semecarpus Anacardium Juice - UNII:Y0F0BU8RDU) Semecarpus Anacardium Juice15 [hp_X]  in 1 mL
    Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate15 [hp_X]  in 1 mL
    Asafetida (UNII: W9FZA51AS1) (Asafetida - UNII:W9FZA51AS1) Asafetida15 [hp_X]  in 1 mL
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
    Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita15 [hp_X]  in 1 mL
    Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9) Black Cohosh15 [hp_X]  in 1 mL
    Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72) Arabica Coffee Bean15 [hp_X]  in 1 mL
    Cypripedium Parvifolum Root (UNII: 21Y9GZ1LZA) (Cypripedium Parvifolum Root - UNII:21Y9GZ1LZA) Cypripedium Parvifolum Root15 [hp_X]  in 1 mL
    Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root15 [hp_X]  in 1 mL
    Hyoscyamus Niger (UNII: 4WRK2153H3) (Hyoscyamus Niger - UNII:4WRK2153H3) Hyoscyamus Niger15 [hp_X]  in 1 mL
    Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum15 [hp_X]  in 1 mL
    Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K) Strychnos Ignatii Seed15 [hp_X]  in 1 mL
    Potassium Phosphate, Dibasic (UNII: CI71S98N1Z) (Phosphate Ion - UNII:NK08V8K8HR) Potassium Phosphate, Dibasic15 [hp_X]  in 1 mL
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
    Sambucus Nigra Flowering Top (UNII: CT03BSA18U) (Sambucus Nigra Flowering Top - UNII:CT03BSA18U) Sambucus Nigra Flowering Top15 [hp_X]  in 1 mL
    Strychnine (UNII: H9Y79VD43J) (Strychnine - UNII:H9Y79VD43J) Strychnine15 [hp_X]  in 1 mL
    Theridion Curassavicum (UNII: 9Z8D3HEM8L) (Theridion Curassavicum - UNII:9Z8D3HEM8L) Theridion Curassavicum15 [hp_X]  in 1 mL
    Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian15 [hp_X]  in 1 mL
    Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O) Passiflora Incarnata Flowering Top3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2244-129.57 mL in 1 BOTTLE, GLASS
    2NDC:55714-2244-259.14 mL in 1 BOTTLE, GLASS
    3NDC:55714-2244-0.5 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-2244)
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