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, goldenseal, iris versicolor root and urtica urens liquid 
Newton Laboratories, Inc.

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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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PRODUCT NAME & INDICATIONS SECTION

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

DIRECTION 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

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.        

PURPOSE SECTION

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

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, GA30012
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 or 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

BACTERIAL INFECTION  
anthracinum , pyrogenium, aconitum nap., arnica, arsenicum alb., baptisia, bryonia, hydrastis, iodium , lachesis, nux vom., phosphorus, pulsatilla, rhus toxicodendron , echinacea , hydrastis, iris versicolor , urtica ur liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:55714-4550
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacillus Anthracis Immunoserum Rabbit (Bacillus Anthracis Immunoserum Rabbit) Bacillus Anthracis Immunoserum Rabbit30 [hp_X]  in 1 mL
Rancid Beef (Rancid Beef) Rancid Beef30 [hp_X]  in 1 mL
Aconitum Napellus (Aconitum Napellus) Aconitum Napellus15 [hp_X]  in 1 mL
Arnica Montana (Arnica Montana) Arnica Montana15 [hp_X]  in 1 mL
Arsenic Trioxide (Arsenic Trioxide) Arsenic Trioxide15 [hp_X]  in 1 mL
Baptisia Tinctoria Root (Baptisia Tinctoria Root) Baptisia Tinctoria Root15 [hp_X]  in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root15 [hp_X]  in 1 mL
Goldenseal (Goldenseal) Goldenseal15 [hp_X]  in 1 mL
Iodine (Iodine) Iodine15 [hp_X]  in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom) Lachesis Muta Venom15 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
Phosphorus (Phosphorus) Phosphorus15 [hp_X]  in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris) Pulsatilla Vulgaris15 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified3 [hp_X]  in 1 mL
Goldenseal (Goldenseal) Goldenseal3 [hp_X]  in 1 mL
Iris Versicolor Root (Iris Versicolor Root) Iris Versicolor Root3 [hp_X]  in 1 mL
Urtica Urens (Urtica Urens) Urtica Urens3 [hp_X]  in 1 mL
Packaging
#Item CodePackage Description
1NDC:55714-4550-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-4550-259.14 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, API MANUFACTURE

Revised: 06/2011
 
Newton Laboratories, Inc.