Distress 4772p

Distress 4772p
SPL v2
SPL
SPL Set ID 98d0be75-9b50-1e15-e053-2995a90abf3b
Route
ORAL
Published
Effective Date 2018-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Angelica Sinensis Root (20 [hp_X]) American Ginseng (11 [hp_X]) Silver Cation Arsenic Cation (3+) Capsicum Cinchona Officinalis Bark Digitalis Gelsemium Sempervirens Root Hypericum Perforatum Strychnos Ignatii Seed Iodine Bromide Ion Carbonate Ion Magnesium Cation Chloride Ion Phosphorus Salix Nigra Bark Sanguinaria Canadensis Root Sepia Officinalis Juice Datura Stramonium Echinacea, Unspecified Ginkgo Berberis Aquifolium Root Bark
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-02
Description

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

Purpose

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

Medication Information

Purpose

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

Description

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

Package Label

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.

Questions Section

newtonlabs.net - Questions? 800 448-7256

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

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.

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 Pregnancy Or Breast Feeding Section

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

Otc Keep Out of Reach of Children Section

Keep out of reach of children.

Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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.

Questions Section (QUESTIONS SECTION)

newtonlabs.net - Questions? 800 448-7256

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

Otc Purpose Section (OTC - PURPOSE SECTION)

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

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

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

Dosage & Administration Section (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 (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 Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

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

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:56.554659 · Updated: 2026-03-14T23:14:59.768699