DISTRESS-MOOD-SADNESS- 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 pellet 
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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Distress 4772P

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth (ages 6 to 11, give 3 pellets) as needed or as directed by a health professional. Sensitive persons begin with 1 pellet and gradually increase to full dose. Warning: If symptoms worsen or persist, especially if suicidal thoughts are present, consult a licensed health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 11x, Ginkgo 11x, Angelica sin. 20x, Aralia quin. 20x, Arg. nit. 20x, Arsenicum alb. 20x, Berber. aqui. 20x, Capsicum 20x, Cinchona 20x, Digitalis 20x, Gelsemium 20x, Hypericum 20x, Ignatia 20x, Iodium 20x, Kali brom. 20x, Kali carb. 20x, Mag. phos. 20x, Nat. carb. 20x, Nat. mur. 20x, Phos. 20x, Salix nigra 20x, Sanguinaria 20x, Sepia 20x, Stramonium 20x.

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingedients: Gluten-free, non-GMO, organc beet-derived sucrose (lactose-free) pellets.

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 taper-evident seal is broken or missing. If symptoms worsen or persist for more than few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

PACKAGE LABEL

package label

DISTRESS-MOOD-SADNESS 
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 pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-4772
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG) ANGELICA SINENSIS ROOT20 [hp_X]  in 1 g
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG20 [hp_X]  in 1 g
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE20 [hp_X]  in 1 g
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE20 [hp_X]  in 1 g
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM20 [hp_X]  in 1 g
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK20 [hp_X]  in 1 g
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS20 [hp_X]  in 1 g
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT20 [hp_X]  in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM20 [hp_X]  in 1 g
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED20 [hp_X]  in 1 g
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE20 [hp_X]  in 1 g
POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE20 [hp_X]  in 1 g
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE20 [hp_X]  in 1 g
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE20 [hp_X]  in 1 g
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE20 [hp_X]  in 1 g
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE20 [hp_X]  in 1 g
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS20 [hp_X]  in 1 g
SALIX NIGRA BARK (UNII: QU52J3A5B3) (SALIX NIGRA BARK - UNII:QU52J3A5B3) SALIX NIGRA BARK20 [hp_X]  in 1 g
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT20 [hp_X]  in 1 g
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE20 [hp_X]  in 1 g
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM20 [hp_X]  in 1 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED11 [hp_X]  in 1 g
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO11 [hp_X]  in 1 g
BERBERIS AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB) (BERBERIS AQUIFOLIUM ROOT BARK - UNII:VZJ9F3C3SB) BERBERIS AQUIFOLIUM ROOT BARK20 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4772-128 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/02/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-4772)

Revised: 12/2020
Document Id: b582999c-14bf-6f3e-e053-2a95a90a2eeb
Set id: 98d0be75-9b50-1e15-e053-2995a90abf3b
Version: 2
Effective Time: 20201202
 
Newton Laboratories, Inc.