FDA.reportPublic FDA data

Depression - Mood - Distress-Adjunctive Complex

Manufacturer
Newton Laboratories, Inc.
Effective date
2019-11-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:57:46

Label at a glance#

ProductDepression - Mood - Distress-Adjunctive Complex
Active ingredientANGELICA SINENSIS ROOT, AMERICAN GINSENG, SILVER NITRATE, ARSENIC TRIOXIDE, BERBERIS AQUIFOLIUM ROOT BARK, CAPSICUM, CINCHONA OFFICINALIS BARK, DIGITALIS, GELSEMIUM SEMPERVIRENS ROOT, HYPERICUM PERFORATUM, STRYCHNOS IGNATII SEED, IODINE, POTASSIUM BROMIDE, POTASSIUM CARBONATE, MAGNESIUM PHOSPHATE, DIBASIC, SODIUM CARBONATE, SODIUM CHLORIDE, PHOSPHORUS, SALIX NIGRA BARK, SANGUINARIA CANADENSIS ROOT, SEPIA OFFICINALIS JUICE, DATURA STRAMONIUM, ECHINACEA, UNSPECIFIED, GINKGO
Label structure9 sections

Label contents#

Full prescribing information#

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING SECTION

OTC - 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 no 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

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

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

INACTIVE INGREDIENT SECTION

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

ACTIVE INGREDIENT SECTION

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 nig. 20x, Sanguinaria 20x, Sepia 20x, Stramonium 20x.

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. Warning: If symptoms worsen or persist, especially if suicidal thoughts are present, consult a licensed health professional.

INDICATIONS & USAGE SECTION

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

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-466255714-4662-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
ANGELICA SINENSIS ROOTB66F4574UGACTIB
AMERICAN GINSENG8W75VCV53QACTIB
SILVER NITRATE95IT3W8JZEACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BERBERIS AQUIFOLIUM ROOT BARKVZJ9F3C3SBACTIB
CAPSICUM00UK7646FGACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
DIGITALISF1T8QT9U8BACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
IODINE9679TC07X4ACTIB
POTASSIUM BROMIDEOSD78555ZMACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
MAGNESIUM PHOSPHATE, DIBASICA1Y870209ZACTIB
SODIUM CARBONATE45P3261C7TACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
PHOSPHORUS27YLU75U4WACTIB
SALIX NIGRA BARKQU52J3A5B3ACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
DATURA STRAMONIUMG6W4F0V8Z3ACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
GINKGO19FUJ2C58TACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b6745f68-8f03-2e90-e053-2a95a90a116397f64041-033c-bb6f-e053-2a95a90a06b02020-12-14WarningsExact identifier
spl set id: 97f64041-033c-bb6f-e053-2a95a90a06b0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.