BLUES - MOOD SUPPORT - angelica sinensis root, american ginseng, silver nitrate, arsenic trioxide, 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 and mahonia aquifolium root bark 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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INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION 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. Sensitive persons begin with 1 drop and gradually increase to full dose. Warning: If symptoms worsen or persist, especially if suicidal thoughts are present, consult a licensed healthcare professional.

OTC - ACTIVE INGREDIENT SECTION

Angelica sinensis radix 10x, Aralia quinquefolia 10x, Arg. nit. 10x, Arsenicum alb. 10x, Berber. aqui. 10x, Capsicum 10x, Cinchona 10x, Digitalis 10x, Gelsemium 10x, Hypericum 10x, Ignatia 10x, Iodium 10x, Kali brom. 10x, Kali carb. 10x, Mag. phos. 10x, Nat. carb. 10x, Nat. mur. 10x, Phosphorus 10x, Salix nigra 10x, Sanguinaria 10x, Sepia 10x, Stramonium 10x, Echinacea 3x, Ginkgo 3x.

OTC - 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, 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

BLUES - 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 OTC DRUG	Item Code (Source)	NDC:55714-2268
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	10 [hp_X] in 1 mL
American Ginseng (American Ginseng)	American Ginseng	10 [hp_X] in 1 mL
Silver Nitrate (Silver Cation)	Silver Nitrate	10 [hp_X] in 1 mL
Arsenic Trioxide (Arsenic Cation (3+))	Arsenic Trioxide	10 [hp_X] in 1 mL
Capsicum (Capsicum)	Capsicum	10 [hp_X] in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark)	Cinchona Officinalis Bark	10 [hp_X] in 1 mL
Digitalis (Digitalis)	Digitalis	10 [hp_X] in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root)	Gelsemium Sempervirens Root	10 [hp_X] in 1 mL
Hypericum Perforatum (Hypericum Perforatum)	Hypericum Perforatum	10 [hp_X] in 1 mL
Strychnos Ignatii Seed (Strychnos Ignatii Seed)	Strychnos Ignatii Seed	10 [hp_X] in 1 mL
Iodine (Iodine)	Iodine	10 [hp_X] in 1 mL
Potassium Bromide (Potassium Cation)	Potassium Bromide	10 [hp_X] in 1 mL
Potassium Carbonate (Carbonate Ion)	Potassium Carbonate	10 [hp_X] in 1 mL
Magnesium Phosphate, Dibasic Trihydrate (Magnesium Cation)	Magnesium Phosphate, Dibasic Trihydrate	10 [hp_X] in 1 mL
Sodium Carbonate (Carbonate Ion)	Sodium Carbonate	10 [hp_X] in 1 mL
Sodium Chloride (Chloride Ion)	Sodium Chloride	10 [hp_X] in 1 mL
Phosphorus (Phosphorus)	Phosphorus	10 [hp_X] in 1 mL
Salix Nigra Bark (Salix Nigra Bark)	Salix Nigra Bark	10 [hp_X] in 1 mL
Sanguinaria Canadensis Root (Sanguinaria Canadensis Root)	Sanguinaria Canadensis Root	10 [hp_X] in 1 mL
Sepia Officinalis Juice (Sepia Officinalis Juice)	Sepia Officinalis Juice	10 [hp_X] in 1 mL
Datura Stramonium (Datura Stramonium)	Datura Stramonium	10 [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
Mahonia Aquifolium Root Bark (Mahonia Aquifolium Root Bark)	Mahonia Aquifolium Root Bark	10 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol

Packaging
#	Item Code	Package Description
1	NDC:55714-2268-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-2268-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-2268-0	.5 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-2268), API MANUFACTURE(55714-2268)

Revised: 03/2011

Document Id: 0eee4db6-29b8-797e-5339-0fd07e0c2778

Set id: 434bd82f-11b7-ce60-7663-0d3d580dcf71

Version: 1

Effective Time: 20110301

Newton Laboratories, Inc.