Label: EXHAUSTION CHRONIC FATIGUE- aconitum nap., adrenalinum, aralia quinquefolia, arnica, arsenicum alb., baptisia, bryonia, cantharis, chelidonium majus, cinchona, iodium, kali carb., kali iod.,lachesis,lycopodium, lycopus virginicus, nat. mur., nux vom., phosphorus, pulsatilla, rhus toxicodendron, sabal, thyroidinum, echinacea, gingko, phytolacca, alcohol liquid

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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

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  • PRODUCT NAME & INDICATIONS SECTION

    Exhaustion~Chronic Fatigue  Formulated for symptoms associated with severe fatigue, Epstein-Barr, Chronic Fatigue Syndrome, adrenal exhaustion and other related conditions.

  • DIRECTION SECTION

    Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 6 to 11, give 3 drops) as needed or as directed by a healthcare professional.

  • ACTIVE INGREDIENT SECTION

    Aconitum nap. 20x, Adrenalinum 20x, Aralia quinquefolia 20x, Arnica 20x, Arsenicum alb. 20x, Baptisia 20x, Bryonia 20x, Cantharis 20x, Chelidonium majus 20x, Cinchona 20x, Iodium 20x, Kali carb. 20x, Kali iod. 20x, Lachesis 20x, Lycopodium 20x, Lycopus virginicus 20x, Nat. mur. 20x, Nux vom. 20x, Phosphorus 20x, Pulsatilla 20x, Rhus toxicodendron 20x, Sabal 20x, Thyroidinum 20x, Echinacea 8x, Gingko 8x, Phytolacca 8x, Echinacea 3x, Gingko 3x, Phytolacca 3x.

  • PURPOSE SECTION

     Formulated for symptoms associated with severe fatigue, Epstein-Barr, Chronic Fatigue Syndrome, adrenal exhaustion 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.  

  • 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
    EXHAUSTION CHRONIC FATIGUE  
    aconitum nap., adrenalinum, aralia quinquefolia, arnica, arsenicum alb., baptisia, bryonia, cantharis, chelidonium majus, cinchona, iodium, kali carb., kali iod.,lachesis,lycopodium, lycopus virginicus, nat. mur., nux vom., phosphorus, pulsatilla, rhus toxicodendron, sabal, thyroidinum, echinacea, gingko, phytolacca, alcohol liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4552
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus20 [hp_X]  in 1 mL
    Epinephrine (UNII: YKH834O4BH) (Epinephrine - UNII:YKH834O4BH) Epinephrine20 [hp_X]  in 1 mL
    American Ginseng (UNII: 8W75VCV53Q) (American Ginseng - UNII:8W75VCV53Q) American Ginseng20 [hp_X]  in 1 mL
    Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana20 [hp_X]  in 1 mL
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide20 [hp_X]  in 1 mL
    Baptisia Tinctoria (UNII: 5K1UO2888Y) (Baptisia Tinctoria - UNII:5K1UO2888Y) Baptisia Tinctoria20 [hp_X]  in 1 mL
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root20 [hp_X]  in 1 mL
    Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria20 [hp_X]  in 1 mL
    Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus20 [hp_X]  in 1 mL
    Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark20 [hp_X]  in 1 mL
    Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine20 [hp_X]  in 1 mL
    Potassium Carbonate (UNII: BQN1B9B9HA) (Carbonate Ion - UNII:7UJQ5OPE7D) Potassium Carbonate20 [hp_X]  in 1 mL
    Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q) Potassium Iodide20 [hp_X]  in 1 mL
    Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom20 [hp_X]  in 1 mL
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore20 [hp_X]  in 1 mL
    Lycopus Virginicus (UNII: TWH5125Q6F) (Lycopus Virginicus - UNII:TWH5125Q6F) Lycopus Virginicus20 [hp_X]  in 1 mL
    Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37) Sodium Chloride20 [hp_X]  in 1 mL
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed20 [hp_X]  in 1 mL
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus20 [hp_X]  in 1 mL
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris20 [hp_X]  in 1 mL
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf20 [hp_X]  in 1 mL
    Saw Palmetto (UNII: J7WWH9M8QS) (Saw Palmetto - UNII:J7WWH9M8QS) Saw Palmetto20 [hp_X]  in 1 mL
    Thyroid, Unspecified (UNII: 0B4FDL9I6P) (Thyroid, Unspecified - UNII:0B4FDL9I6P) Thyroid, Unspecified20 [hp_X]  in 1 mL
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified8 [hp_X]  in 1 mL
    Ginkgo (UNII: 19FUJ2C58T) (Ginkgo - UNII:19FUJ2C58T) Ginkgo8 [hp_X]  in 1 mL
    Phytolacca Americana Root (UNII: 11E6VI8VEG) (Phytolacca Americana Root - UNII:11E6VI8VEG) Phytolacca Americana Root8 [hp_X]  in 1 mL
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 mL
    Ginkgo (UNII: 19FUJ2C58T) (Ginkgo - UNII:19FUJ2C58T) Ginkgo3 [hp_X]  in 1 mL
    Phytolacca Americana Root (UNII: 11E6VI8VEG) (Phytolacca Americana Root - UNII:11E6VI8VEG) Phytolacca Americana Root3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4552-129.57 mL in 1 BOTTLE, GLASS
    2NDC:55714-4552-259.14 mL 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(55714-4552) , API MANUFACTURE(55714-4552)
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