INTESTINAL BACTERIA - rancid beef, arsenic trioxide, baptisia tinctoria root, bryonia alba root, cinchona officinalis bark, collinsonia canadensis root, iodine, iris versicolor root, lachesis muta venom, lycopodium clavatum spore, sodium carbonate, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, toxicodendron pubescens leaf, dioscorea villosa tuber, echinacea, unspecified, urtica urens and podophyllum 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.

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Intestinal Bacteria

INDICATIONS & USAGE SECTION

Intestinal Bacteria Formulated for symptoms of bacterial imbalance of the gastro-intestinal tract such as diarrhea, dyspepsia, fever, cramping, nausea and vomiting.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

Pyrogenium 30x, Arsenicum alb. 15x, Baptisia 15x, Bryonia 15x, Cinchona 15x, Collinsonia 15x, Iodium15x, Iris versicolor 15x, Lachesis 15x, Lycopodium 15x, Nat. carb. 15x, Nat. mur. 15x, Nux vom. 15x, Phosphorus 15x, Podoph. pelt. 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Dioscorea 3x, Echinacea 3x, Iris versicolor 3x, Urtica ur. 3x.

PURPOSE SECTION

Formulated for symptoms of bacterial imbalance of the gastro-intestinal tract such as diarrhea, dyspepsia, fever, cramping, nausea and vomiting.

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.

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.

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

INTESTINAL BACTERIA
pyrogenium, arsenicum alb.,baptisia, bryonia, cinchona, collinsonia, iodium, iris versicolor, lachesis, lycopodium, nat. carb.,nat.mur.,nux vom., phosphorus, podoph. pelt., pulsatilla, rhus toxicodendron, dioscorea, echinacea, urtica ur. liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:55714-4548
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Rancid Beef (Rancid Beef)	Rancid Beef	30 [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
Cinchona Officinalis Bark (Cinchona Officinalis Bark)	Cinchona Officinalis Bark	15 [hp_X] in 1 mL
Collinsonia Canadensis Root (Collinsonia Canadensis Root)	Collinsonia Canadensis Root	15 [hp_X] in 1 mL
Iodine (Iodine)	Iodine	15 [hp_X] in 1 mL
Iris Versicolor Root (Iris Versicolor Root)	Iris Versicolor Root	15 [hp_X] in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom)	Lachesis Muta Venom	15 [hp_X] in 1 mL
Lycopodium Clavatum Spore (Lycopodium Clavatum Spore)	Lycopodium Clavatum Spore	15 [hp_X] in 1 mL
Sodium Carbonate (Carbonate Ion)	Sodium Carbonate	15 [hp_X] in 1 mL
Sodium Chloride (Chloride Ion)	Sodium Chloride	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
Dioscorea Villosa Tuber (Dioscorea Villosa Tuber)	Dioscorea Villosa Tuber	3 [hp_X] in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified)	Echinacea, Unspecified	3 [hp_X] in 1 mL
Urtica Urens (Urtica Urens)	Urtica Urens	3 [hp_X] in 1 mL
Podophyllum (Podophyllum)	Podophyllum	15 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Alcohol

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-4548-1	29.57 mL in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-4548)

Revised: 6/2011

Document Id: e167eb5c-6117-a5e0-21e0-82c96445ee40

Set id: 70bb951d-fa42-5062-5d94-07292c6e7e73

Version: 2

Effective Time: 20110601

Newton Laboratories, Inc.