Gastritis – Ulcer: Homeopathic Product Information

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.

Package Label

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION 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.

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

Package Label
(click image for full-size original)

GASTRITIS — ULCER
antimon. crud., arg. nit., arsenicum alb., baptisia, bismuthum metallicum, bryonia, cinchona, colocynthis, graphites, hepar sulph. 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 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 Trisulfide) 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 Multilevel Packaging
1 NDC:55714-4530-1 29.57 mL in 1 BOTTLE, GLASS None
2 NDC:55714-4530-2 59.14 mL in 1 BOTTLE, GLASS None
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 Operations
Newton Laboratories, Inc. 788793610 MANUFACTURE (55714-4530)

Revised: 06/2011 Newton Laboratories, Inc.

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