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
- NDC Code(s): 55714-4772-1
- Packager: Newton Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated December 2, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
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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.
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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
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
newtonlabs.net - Questions? 800 448-7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
- WARNINGS SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
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 pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-4772 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG) ANGELICA SINENSIS ROOT 20 [hp_X] in 1 g AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG 20 [hp_X] in 1 g SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 20 [hp_X] in 1 g ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 20 [hp_X] in 1 g CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 20 [hp_X] in 1 g CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 20 [hp_X] in 1 g DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS 20 [hp_X] in 1 g GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 20 [hp_X] in 1 g HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 20 [hp_X] in 1 g STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 20 [hp_X] in 1 g IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 20 [hp_X] in 1 g POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE 20 [hp_X] in 1 g POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 20 [hp_X] in 1 g MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 20 [hp_X] in 1 g SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE 20 [hp_X] in 1 g SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 20 [hp_X] in 1 g PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 20 [hp_X] in 1 g SALIX NIGRA BARK (UNII: QU52J3A5B3) (SALIX NIGRA BARK - UNII:QU52J3A5B3) SALIX NIGRA BARK 20 [hp_X] in 1 g SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 20 [hp_X] in 1 g SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 20 [hp_X] in 1 g DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM 20 [hp_X] in 1 g ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 11 [hp_X] in 1 g GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO 11 [hp_X] in 1 g BERBERIS AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB) (BERBERIS AQUIFOLIUM ROOT BARK - UNII:VZJ9F3C3SB) BERBERIS AQUIFOLIUM ROOT BARK 20 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4772-1 28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/02/2019 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-4772)
