DEPRESSION MOOD SUPPORT - angelica sinensis root, american ginseng, silver nitrate, arsenic trioxide, mahonia aquifolium root bark, capsicum, cinchona officinalis bark, digitalis, gelsemium sempervirens root, hypericum perforatum, strychnos ignatii seed, iodine, potassium bromide, potassium carbonate, magnesium phosphate, dibasic trihydrate, sodium carbonate, sodium chloride, phosphorus, salix nigra bark, sanguinaria canadensis root, sepia officinalis juice, datura stramonium, echinacea, unspecified, ginkgo, echinacea, unspecified and ginkgo 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

DEPRESSION MOOD SUPPORT Formulated for associated symptoms such as grief, despondency, difficult concentration, irritability, oversensitivity and prolonged sadness.

DIRECTION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 6 to 11, give 3 drops) as needed or as directed by a healthcare professional. Warning: If symptoms worsen or persist, especially if suicidal thoughts are present, consult a licensed healthcare professional.

ACTIVE INGREDIENT SECTION

Angelica sinensis, radix 15x, Aralia quinquefolia 15x, Arg. nit. 15x, Arsenicum alb. 15x, Berber. aqui. 15x, Capsicum 15x, Cinchona 15x, Digitalis 15x, Gelsemium 15x, Hypericum 15x, Ignatia 15x, Iodium 15x, Kali brom. 15x, Kali carb. 15x, Mag. phos. 15x, Nat. carb. 15x, Nat. mur. 15x, Phosphorus 15x, Salix nigra 15x, Sanguinaria 15x, Sepia 15x, Stramonium 15x, Echinacea 8x, Ginkgo 8x, Echinacea 3x, Ginkgo 3x.

PURPOSE SECTION

Formulated for associated symptoms such as grief, despondency, difficult concentration, irritability, oversensitivity and prolonged sadness.

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 or 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

DEPRESSION MOOD SUPPORT
angelica sinensis, radix, aralia quinquefolia, arg. nit., arsenicum alb., berber. aqui., capsicum, cinchona,digitalis,gelsemium, hypericum, ignatia, iodium, kali brom., kali carb., mag. phos., nat. carb., nat. mur., phosphorus, salix nigra, sanguinaria, sepia, stramonium, echinacea, ginkgo liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:55714-4566
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Angelica Sinensis Root (Angelica Sinensis Root)	Angelica Sinensis Root	15 [hp_X] in 1 mL
American Ginseng (American Ginseng)	American Ginseng	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
Mahonia Aquifolium Root Bark (Mahonia Aquifolium Root Bark)	Mahonia Aquifolium Root Bark	15 [hp_X] in 1 mL
Capsicum (Capsicum)	Capsicum	15 [hp_X] in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark)	Cinchona Officinalis Bark	15 [hp_X] in 1 mL
Digitalis (Digitalis)	Digitalis	15 [hp_X] in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root)	Gelsemium Sempervirens Root	15 [hp_X] in 1 mL
Hypericum Perforatum (Hypericum Perforatum)	Hypericum Perforatum	15 [hp_X] in 1 mL
Strychnos Ignatii Seed (Strychnos Ignatii Seed)	Strychnos Ignatii Seed	15 [hp_X] in 1 mL
Iodine (Iodine)	Iodine	15 [hp_X] in 1 mL
Potassium Bromide (Potassium Cation)	Potassium Bromide	15 [hp_X] in 1 mL
Potassium Carbonate (Carbonate Ion)	Potassium Carbonate	15 [hp_X] in 1 mL
Magnesium Phosphate, Dibasic Trihydrate (Magnesium Cation)	Magnesium Phosphate, Dibasic Trihydrate	15 [hp_X] in 1 mL
Sodium Carbonate (Carbonate Ion)	Sodium Carbonate	15 [hp_X] in 1 mL
Sodium Chloride (Sodium Cation)	Sodium Chloride	15 [hp_X] in 1 mL
Phosphorus (Phosphorus)	Phosphorus	15 [hp_X] in 1 mL
Salix Nigra Bark (Salix Nigra Bark)	Salix Nigra Bark	15 [hp_X] in 1 mL
Sanguinaria Canadensis Root (Sanguinaria Canadensis Root)	Sanguinaria Canadensis Root	15 [hp_X] in 1 mL
Sepia Officinalis Juice (Sepia Officinalis Juice)	Sepia Officinalis Juice	15 [hp_X] in 1 mL
Datura Stramonium (Datura Stramonium)	Datura Stramonium	15 [hp_X] in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified)	Echinacea, Unspecified	8 [hp_X] in 1 mL
Ginkgo (Ginkgo)	Ginkgo	8 [hp_X] in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified)	Echinacea, Unspecified	3 [hp_X] in 1 mL
Ginkgo (Ginkgo)	Ginkgo	3 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol

Packaging
#	Item Code	Package Description
1	NDC:55714-4566-1	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(55714-4566), API MANUFACTURE(55714-4566)

Revised: 06/2011

Document Id: 59880024-f9c4-9082-6deb-65a0ab50805d

Set id: 19189f54-5f6d-4cee-8db7-3d560843e059

Version: 1

Effective Time: 20110601

Newton Laboratories, Inc.