DIGESTIVE CARE - antimony trisulfide, silver nitrate, arsenic trioxide, baptisia tinctoria root, bismuth, bryonia alba root, matricaria recutita, cinchona officinalis bark, iris versicolor root, potassium dichromate, lachesis muta venom, lycopodium clavatum spore, magnesium carbonate, strychnos nux-vomica seed, phosphorus, podophyllum, pulsatilla vulgaris, daikon, toxicodendron pubescens leaf, tobacco leaf, verbascum thapsus, ginger, echinacea, unspecified and juglans regia fruit rind, immature 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

Digestive Care Formulated for digestive health and for symptoms associated with IBS, GERD, 'leaky gut' syndrome, dyspepsia and other GI conditions.

DIRECTION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) 15 minutes before meals or as needed 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, Chamomilla 15x, Cinchona 15x, Iris versicolor 15x, Kali bic. 15x, Lachesis 15x, Lycopodium 15x, Mag. carb. 15x, Nux vom.15x, Phosphorus 15x, Podoph. pelt. 15x, Pulsatilla 15x, Raphanus 15x, Rhus toxicodendron 15x, Tabacum 15x, Verbascum 15x, Zingiber 15x, Echinacea 3x, Juglans regia 3x.

PURPOSE SECTION

Formulated for digestive health and for symptoms associated with IBS, GERD, 'leaky gut' syndrome, dyspepsia and other GI conditions.

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

DIGESTIVE CARE
antimon. crud., arg. nit.,arsenicum alb., baptisia, bismuthum metallicum,bryonia, chamomilla, cinchona, iris versicolor, kalibic., lachesis, lycopodium, mag. carb., nux vom., phosphorus, podoph. pelt., pulsatilla, raphanus, rhus toxicodendron, tabacum, verbascum, zingiber, echinacea, juglans regia liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:55714-4510
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 Root (Baptisia Tinctoria Root)	Baptisia Tinctoria Root	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
Matricaria Recutita (Matricaria Recutita)	Matricaria Recutita	15 [hp_X] in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark)	Cinchona Officinalis Bark	15 [hp_X] in 1 mL
Iris Versicolor Root (Iris Versicolor Root)	Iris Versicolor Root	15 [hp_X] in 1 mL
Potassium Dichromate (Dichromate Ion)	Potassium Dichromate	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
Magnesium Carbonate (Carbonate Ion)	Magnesium Carbonate	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
Daikon (Daikon)	Daikon	15 [hp_X] in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf)	Toxicodendron Pubescens Leaf	15 [hp_X] in 1 mL
Tobacco Leaf (Tobacco Leaf)	Tobacco Leaf	15 [hp_X] in 1 mL
Verbascum Thapsus (Verbascum Thapsus)	Verbascum Thapsus	15 [hp_X] in 1 mL
Ginger (Ginger)	Ginger	15 [hp_X] in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified)	Echinacea, Unspecified	3 [hp_X] in 1 mL
Juglans Regia Fruit Rind, Immature (Juglans Regia Fruit Rind, Immature)	Juglans Regia Fruit Rind, Immature	3 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol

Packaging
#	Item Code	Package Description
1	NDC:55714-4510-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-4510-2	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(55714-4510), API MANUFACTURE(55714-4510)

Revised: 06/2011

Document Id: b3f284d7-cacb-48e3-108e-9c3e8367cb44

Set id: cb2feba5-0067-8609-3661-6e49ec553063

Version: 1

Effective Time: 20110601

Newton Laboratories, Inc.