BLUES - MOOD - EMOTIONS- 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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Blues 2390L

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

INDICATIONS & USAGE SECTION

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

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

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Ginkgo 6x, Angelica sin. 15x, Aralia quin. 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, Phos. 15x, Salix nigra 15x, Sanguinaria 15x, Sepia 15x, Stramonium 15x.

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 alcohol 20%.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

QUESTIONS SECTION

newtonlabs.net ~ Questions? 800.448.7256

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

WARNINGS SECTION

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

PACKAGE LABEL

package label

BLUES - MOOD - EMOTIONS
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:55714-2390
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	6 [hp_X] in 1 mL
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T)	GINKGO	6 [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
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
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-2390-0	0.5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	10/31/2018	07/01/2019
2	NDC:55714-2390-1	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	10/31/2018
3	NDC:55714-2390-2	50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	10/31/2018	07/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/31/2018

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-2390)

Revised: 7/2019

Document Id: 8e99ae3f-5279-969d-e053-2995a90ac9e5

Set id: 79890e75-dfac-0262-e053-2a91aa0a5ce5

Version: 4

Effective Time: 20190726

Newton Laboratories, Inc.