Distress-Mood-Sadness
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2020-12-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:13:43
Label at a glance#
ProductDistress-Mood-Sadness
Active ingredientANGELICA SINENSIS ROOT, AMERICAN GINSENG, SILVER NITRATE, ARSENIC TRIOXIDE, CAPSICUM, CINCHONA OFFICINALIS BARK, DIGITALIS, GELSEMIUM SEMPERVIRENS ROOT, HYPERICUM PERFORATUM, STRYCHNOS IGNATII SEED, IODINE, POTASSIUM BROMIDE, POTASSIUM CARBONATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM CARBONATE, SODIUM CHLORIDE, PHOSPHORUS, SALIX NIGRA BARK, SANGUINARIA CANADENSIS ROOT, SEPIA OFFICINALIS JUICE, DATURA STRAMONIUM, ECHINACEA, UNSPECIFIED, GINKGO, BERBERIS AQUIFOLIUM ROOT BARK
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
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
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4772-1 | Distress-Mood-Sadness | 28 g in 1 BOTTLE, GLASS | PELLET | 28 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-4772 | 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.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20201203_98d0be75-9b50-1e15-e053-2995a90abf3b.zip |
Products#
Every source-derived product name is available through these pages.
- 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
- SUCROSE
- ANGELICA SINENSIS ROOT
- AMERICAN GINSENG
- SILVER NITRATE
- SILVER CATION
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- CAPSICUM
- CINCHONA OFFICINALIS BARK
- DIGITALIS
- GELSEMIUM SEMPERVIRENS ROOT
- HYPERICUM PERFORATUM
- STRYCHNOS IGNATII SEED
- IODINE
- POTASSIUM BROMIDE
- BROMIDE ION
- POTASSIUM CARBONATE
- CARBONATE ION
- MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
- MAGNESIUM CATION
- SODIUM CARBONATE
- SODIUM CHLORIDE
- CHLORIDE ION
- PHOSPHORUS
- SALIX NIGRA BARK
- SANGUINARIA CANADENSIS ROOT
- SEPIA OFFICINALIS JUICE
- DATURA STRAMONIUM
- ECHINACEA, UNSPECIFIED
- GINKGO
- BERBERIS AQUIFOLIUM ROOT BARK
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4772 | 55714-4772-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 | Newton Laboratories, Inc. | 98d0be75-9b50-1e15-e053-2995a90abf3b | 2020-12-02 | Warnings | 55714-4772-1 55714-4772 55714477201 b582999c-14bf-6f3e-e053-2a95a90a2eeb 98d0be75-9b50-1e15-e053-2995a90abf3b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.