GASTRITIS ULCER - antimony trisulfide, silver nitrate, arsenic trioxide, baptisia tinctoria, bismuth, bryonia alba root, cinchona officinalis bark, citrullus colocynthis fruit pulp, graphite, calcium sulfide, goldenseal, ipecac, potassium dichromate, potassium carbonate, lycopodium clavatum spore, magnesium carbonate, magnesium phosphate, dibasic trihydrate, strychnos nux-vomica seed, phosphorus, podophyllum, pulsatilla vulgaris, ginger, matricaria recutita, echinacea, unspecified, iris versicolor root, ruta graveolens flowering top and taraxacum officinale 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

Gastritis~Ulcer Formulated for symptoms associated with gastritis and duodenal, esophageal or stomach ulcers.

DIRECTION SECTION

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

ACTIVE INGREDIENT SECTION

Antimon. crud. 15x, Arg. nit. 15x, Arsenicum alb. 15x, Baptisia 15x, Bismuthum metallicum 15x, Bryonia 15x, Cinchona 15x, Colocynthis 15x, Graphites 15x, Hepar sulph. calc. 15x, Hydrastis 15x, Ipecac. 15x, Kali bic. 15x, Kali carb.15x, Lycopodium 15x, Mag. carb. 15x, Mag. phos. 15x, Nux vom.15x, Phosphorus 15x, Podoph. pelt. 15x, Pulsatilla 15x, Zingiber 15x, Chamomilla 3x, Echinacea 3x, Iris versicolor 3x, Ruta 3x, Taraxacum 3x.

PURPOSE SECTION

Formulated for symptoms associated with gastritis and duodenal, esophageal or stomach ulcers.

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

GASTRITIS ULCER
antimon. crud., arg. nit.,arsenicum alb., baptisia, bismuthum metallicum,bryonia, cinchona, colocynthis, graphites, heparsulph. calc. hydrastis, ipecac., kali bic., kali carb., lycopodium, mag. carb. mag. phos., nux vom., phosphorus, podoph. pelt., pulsatilla, zingiber, chamomilla, echinacea, iris versicolor, ruta,taraxacum liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:55714-4530
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Antimony Trisulfide (Antimony Cation (3+))	Antimony Trisulfide	15 [hp_X] in 1 mL
Silver Nitrate (Silver Cation)	Silver Nitrate	15 [hp_X] in 1 mL
Arsenic Trioxide (Arsenic Cation (3+))	Arsenic Trioxide	15 [hp_X] in 1 mL
Baptisia Tinctoria (Baptisia Tinctoria)	Baptisia Tinctoria	15 [hp_X] in 1 mL
Bismuth (Bismuth)	Bismuth	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
Citrullus Colocynthis Fruit Pulp (Citrullus Colocynthis Fruit Pulp)	Citrullus Colocynthis Fruit Pulp	15 [hp_X] in 1 mL
Graphite (Graphite)	Graphite	15 [hp_X] in 1 mL
Calcium Sulfide (Calcium Sulfide)	Calcium Sulfide	15 [hp_X] in 1 mL
Goldenseal (Goldenseal)	Goldenseal	15 [hp_X] in 1 mL
Ipecac (Ipecac)	Ipecac	15 [hp_X] in 1 mL
Potassium Dichromate (Dichromate Ion)	Potassium Dichromate	15 [hp_X] in 1 mL
Potassium Carbonate (Carbonate Ion)	Potassium Carbonate	15 [hp_X] in 1 mL
Lycopodium Clavatum Spore (Lycopodium Clavatum Spore)	Lycopodium Clavatum Spore	15 [hp_X] in 1 mL
Magnesium Carbonate (Carbonate Ion)	Magnesium Carbonate	15 [hp_X] in 1 mL
Magnesium Phosphate, Dibasic Trihydrate (Magnesium Cation)	Magnesium Phosphate, Dibasic Trihydrate	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
Podophyllum (Podophyllum)	Podophyllum	15 [hp_X] in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris)	Pulsatilla Vulgaris	15 [hp_X] in 1 mL
Ginger (Ginger)	Ginger	15 [hp_X] in 1 mL
Matricaria Recutita (Matricaria Recutita)	Matricaria Recutita	3 [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
Ruta Graveolens Flowering Top (Ruta Graveolens Flowering Top)	Ruta Graveolens Flowering Top	3 [hp_X] in 1 mL
Taraxacum Officinale (Taraxacum Officinale)	Taraxacum Officinale	3 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol

Packaging
#	Item Code	Package Description
1	NDC:55714-4530-1	29.57 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(55714-4530), API MANUFACTURE(55714-4530)

Revised: 06/2011

Document Id: cdaf5fb6-be9a-fab2-e6db-49be73c3c20d

Set id: 8e8f50c9-0609-1735-95bd-49dad6beaecb

Version: 1

Effective Time: 20110601

Newton Laboratories, Inc.