Nervousness 4783l

Nervousness 4783l
SPL v2
SPL
SPL Set ID 99706ce2-d555-88ca-e053-2a95a90abb4b
Route
ORAL
Published
Effective Date 2019-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (20 [hp_X]) Ambergris (11 [hp_X]) Semecarpus Anacardium Juice Silver Cation Ferula Assa-foetida Resin Bryonia Alba Root Matricaria Chamomilla Black Cohosh Arabica Coffee Bean Cypripedium Parviflorum Var. Pubescens Root Gelsemium Sempervirens Root Hyoscyamus Niger Hypericum Perforatum Strychnos Ignatii Seed Phosphate Ion Strychnos Nux-vomica Seed Sambucus Nigra Flowering Top Strychnine Theridion Curassavicum Valerian Passiflora Incarnata Flowering Top
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-02

Description

Formulated for symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

Purpose

Formulated for symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.


Medication Information

Purpose

Formulated for symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

Description

Formulated for symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

Package Label

Warnings Section

WARNINGS: Keep out of reach of children. Do not 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

newtonlabs.net – Questions? 800.448.7256

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

Otc Purpose Section

Formulated for symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section

Formulated for symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by moouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

Otc Active Ingredient Section

Equal parts of Passiflora incarnata 11x, Valeriana officinalis 11x, Aconitum napellus 20x, Ambra grisea 20x, Anacardium orientale 20x, Argentum nitricum 20x, Asafoetida 20x, Bryonia 20x, Chamomilla 20x, Cimicifuga racemosa 20x, Coffea cruda 20x, Cypripedium pubescens 20x, Gelsemium sempervirens 20x, Hyoscyamus niger 20x, Hypericum perforatum 20x, Ignatia amara 20x, Kali phosphoricum 20x, Nux vomica 20x, Sambucus nigra 20x, Strychninum 20x, Theridion 20x, Valeriana officinalis 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 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 (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 symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 drops by moouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Passiflora incarnata 11x, Valeriana officinalis 11x, Aconitum napellus 20x, Ambra grisea 20x, Anacardium orientale 20x, Argentum nitricum 20x, Asafoetida 20x, Bryonia 20x, Chamomilla 20x, Cimicifuga racemosa 20x, Coffea cruda 20x, Cypripedium pubescens 20x, Gelsemium sempervirens 20x, Hyoscyamus niger 20x, Hypericum perforatum 20x, Ignatia amara 20x, Kali phosphoricum 20x, Nux vomica 20x, Sambucus nigra 20x, Strychninum 20x, Theridion 20x, Valeriana officinalis 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)