DEPRESSION - MOOD - DISTRESS- 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
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.

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Depression 4644L-Dis

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

WARNINGS SECTION

Warning: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

QUESTIONS? SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Questions? 1.800.448.7256

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

PURPOSE SECTION

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

ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 3x, Ginkgo 3x, Echinacea 8x, Ginkgo 8x, 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.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 6 to 11, give 3 drops) as needed or as directed by a health professional. Warning: If symptoms worsen or persist, especially if suicidal thoughts are present, consult a licensed health professional.

INDICATIONS & USAGE SECTION

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

PACKAGE LABEL

Package Label

DEPRESSION - MOOD - DISTRESS
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	Item Code (Source)	NDC:55714-4644
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG)	ANGELICA SINENSIS ROOT	15 [hp_X] in 1 mL
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q)	AMERICAN GINSENG	15 [hp_X] in 1 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	15 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	15 [hp_X] in 1 mL
MAHONIA AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB) (MAHONIA AQUIFOLIUM ROOT BARK - UNII:VZJ9F3C3SB)	MAHONIA AQUIFOLIUM ROOT BARK	15 [hp_X] in 1 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	15 [hp_X] in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	15 [hp_X] in 1 mL
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B)	DIGITALIS	15 [hp_X] in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	15 [hp_X] in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	15 [hp_X] in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	15 [hp_X] in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	15 [hp_X] in 1 mL
POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06)	POTASSIUM BROMIDE	15 [hp_X] in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	15 [hp_X] in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	15 [hp_X] in 1 mL
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D)	SODIUM CARBONATE	15 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	15 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	15 [hp_X] in 1 mL
SALIX NIGRA BARK (UNII: QU52J3A5B3) (SALIX NIGRA BARK - UNII:QU52J3A5B3)	SALIX NIGRA BARK	15 [hp_X] in 1 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	15 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	15 [hp_X] in 1 mL
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3)	DATURA STRAMONIUM	15 [hp_X] in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	8 [hp_X] in 1 mL
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T)	GINKGO	8 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-4644-1	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/17/2017	11/29/2019
2	NDC:55714-4644-2	59 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/17/2017	11/29/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/17/2017	11/29/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-4644)

Revised: 11/2019

Document Id: 97f43ca8-adb1-4b9c-e053-2a95a90aee10

Set id: 605258e1-e50c-4086-e053-2a91aa0af29f

Version: 2

Effective Time: 20191122

Newton Laboratories, Inc.