Label: BACTERIAL INFECTION - bacillus anthracis immunoserum rabbit, rancid beef, aconitum napellus, arnica montana, arsenic trioxide, baptisia tinctoria root, bryonia alba root, goldenseal, iodine, lachesis muta venom, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, toxicodendron pubescens leaf, echinacea, unspecified, iris versicolor root and urtica urens liquid

  • NDC Code(s): 55714-4550-1, 55714-4550-2
  • Packager: Newton Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

Drug Label Information

Updated 06/11

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

  • INDICATIONS & USAGE SECTION

    Bacterial Infection  Formulated for symptoms related to bacterial infections such as fever, chills, fatigue, swollen glands, pain, weakness and loss of appetite.      

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  • 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.      

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  • ACTIVE INGREDIENT SECTION

    Anthracinum 30x, Pyrogenium 30x, Aconitum nap.15x, Arnica 15x,  Arsenicum alb.15x, Baptisia 15x, Bryonia 15x, Hydrastis 15x, Iodium 15x, Lachesis 15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Echinacea  3x, Hydrastis 3x, Iris versicolor  3x,  Urtica ur. 3x.        

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  • PURPOSE SECTION

    Formulated for symptoms related to bacterial infections such as fever, chills, fatigue, swollen glands, pain, weakness and loss of appetite. 

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  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients:  USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.     

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  • QUESTIONS? SECTION

    www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
    Questions?  1.800.448.7256    

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  • 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.       

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  •  PREGNANCY OR BREAST FEEDING SECTION

    Consult a licensed healthcare professional if pregnant or nursing or if symptoms worsen or persist for more than a few days.      

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  • KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.       

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  • PACKAGE LABEL
  • INGREDIENTS AND APPEARANCE
    BACTERIAL INFECTION  
    anthracinum , pyrogenium, aconitum nap., arnica, arsenicum alb., baptisia, bryonia, hydrastis, iodium, lachesis, nux vom., phosphorus, pulsatilla, rhus toxicodendron , echinacea , iris versicolor, urtica ur. liquid
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55714-4550
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Bacillus Anthracis Immunoserum Rabbit (Bacillus Anthracis Immunoserum Rabbit) Bacillus Anthracis Immunoserum Rabbit 30 [hp_X]  in 1 mL
    Rancid Beef (Rancid Beef) Rancid Beef 30 [hp_X]  in 1 mL
    Aconitum Napellus (Aconitum Napellus) Aconitum Napellus 15 [hp_X]  in 1 mL
    Arnica Montana (Arnica Montana) Arnica Montana 15 [hp_X]  in 1 mL
    Arsenic Trioxide (Arsenic Cation (3+)) Arsenic Trioxide 15 [hp_X]  in 1 mL
    Baptisia Tinctoria Root (Baptisia Tinctoria Root) Baptisia Tinctoria Root 15 [hp_X]  in 1 mL
    Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root 15 [hp_X]  in 1 mL
    Goldenseal (Goldenseal) Goldenseal 15 [hp_X]  in 1 mL
    Iodine (Iodine) Iodine 15 [hp_X]  in 1 mL
    Lachesis Muta Venom (Lachesis Muta Venom) Lachesis Muta Venom 15 [hp_X]  in 1 mL
    Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed) Strychnos Nux-vomica Seed 15 [hp_X]  in 1 mL
    Phosphorus (Phosphorus) Phosphorus 15 [hp_X]  in 1 mL
    Pulsatilla Vulgaris (Pulsatilla Vulgaris) Pulsatilla Vulgaris 15 [hp_X]  in 1 mL
    Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf) Toxicodendron Pubescens Leaf 15 [hp_X]  in 1 mL
    Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified 3 [hp_X]  in 1 mL
    Iris Versicolor Root (Iris Versicolor Root) Iris Versicolor Root 3 [hp_X]  in 1 mL
    Urtica Urens (Urtica Urens) Urtica Urens 3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Alcohol  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55714-4550-1 29.57 mL in 1 BOTTLE, GLASS
    2 NDC:55714-4550-2 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(55714-4550)
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