Label: STRESS - PANIC- aconitum nap., apis mel., arnica, arsenicum alb., belladonna, bellis, bryonia, calendula, chamomilla, cistus canadensis, ferrum phosphoricum, histaminum hydrochloricum, hypericum, ignatia, mezereum, ornithogalum, passiflora, phosphorus, prunus spin., rhus toxicodendron, sarcolacticum ac., sulphur, veratrum alb., valeriana 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 April 15, 2014

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

  • INDICATIONS & USAGE SECTION

    Stress - Panic  Formulated for symptoms associated with stress and panic such as shock, anxiety, tension, fear or nervousness.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: ORAL USE ONLY -  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, Apis mel. 15x, Arnica 15x, Arsenicum alb. 15x, Belladonna 15x, Bellis 15x, Bryonia 15x, Calendula 15x, Chamomilla 15x, Cistus canadensis 15x, Ferrum phosphoricum 15x, Histaminum hydrochloricum 15x, Hypericum 15x, Ignatia 15x, Mezereum 15x, Ornithogalum 15x, Passiflora 15x, Phos. 15x, Prunus spin. 15x, Rhus tox. 15x, Sarcolacticum ac. 15x, Sulphur 15x, Veratrum alb. 15x, Chamomilla 3x, Valeriana 3x.

  • OTC - PURPOSE SECTION

     Formulated for symptoms associated with stress and panic such as shock, anxiety, tension, fear or nervousness.

  • 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
    STRESS - PANIC  
    aconitum nap., apis mel., arnica, arsenicum alb., belladonna, bellis, bryonia, calendula, chamomilla, cistus canadensis, ferrum phosphoricum, histaminum hydrochloricum, hypericum, ignatia, mezereum, ornithogalum, passiflora, phosphorus, prunus spin., rhus toxicodendron, sarcolacticum ac., sulphur, veratrum alb., valeriana liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-8001
    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
    Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera15 [hp_X]  in 1 mL
    Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana15 [hp_X]  in 1 mL
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Cation (3+)15 [hp_X]  in 1 mL
    Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna15 [hp_X]  in 1 mL
    Bellis Perennis (UNII: 2HU33I03UY) (Bellis Perennis - UNII:2HU33I03UY) Bellis Perennis15 [hp_X]  in 1 mL
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
    Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ) Calendula Officinalis Flowering Top15 [hp_X]  in 1 mL
    Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita15 [hp_X]  in 1 mL
    Helianthemum Canadense (UNII: 46G3W789Q3) (Helianthemum Canadense - UNII:46G3W789Q3) Helianthemum Canadense15 [hp_X]  in 1 mL
    Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7) Ferrosoferric Phosphate15 [hp_X]  in 1 mL
    Histamine Dihydrochloride (UNII: 3POA0Q644U) (Histamine - UNII:820484N8I3) Histamine Dihydrochloride15 [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
    Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark15 [hp_X]  in 1 mL
    Ornithogalum Umbellatum (UNII: 9NS3M2Y78S) (Ornithogalum Umbellatum - UNII:9NS3M2Y78S) Ornithogalum Umbellatum15 [hp_X]  in 1 mL
    Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O) Passiflora Incarnata Flowering Top15 [hp_X]  in 1 mL
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 mL
    Prunus Spinosa Flower Bud (UNII: 53Y84VPS2W) (Prunus Spinosa Flower Bud - UNII:53Y84VPS2W) Prunus Spinosa Flower Bud15 [hp_X]  in 1 mL
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 mL
    Lactic Acid, L- (UNII: F9S9FFU82N) (Lactic Acid, L- - UNII:F9S9FFU82N) Lactic Acid, L-15 [hp_X]  in 1 mL
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur15 [hp_X]  in 1 mL
    Veratrum Album Root (UNII: QNS6W5US1Z) (Veratrum Album Root - UNII:QNS6W5US1Z) Veratrum Album Root15 [hp_X]  in 1 mL
    Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-8001-129.57 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/15/2014
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-8001)