Nervousness 2492p

Nervousness 2492p
SPL v2
SPL
SPL Set ID 9c94ff3a-2451-3617-e053-2a95a90a7cb9
Route
ORAL
Published
Effective Date 2019-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (15 [hp_X]) Ambergris (6 [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
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-01-01

Description

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

Purpose

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


Medication Information

Purpose

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

Description

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

Inactive Ingredient Section

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

Indications & Usage Section

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

Dosage & Administration Section

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section

Equal parts of Passiflora incarnata 6x, Valeriana officinalis 6x, Aconitum napellus 15x, Ambra grisea 15x, Anacardium orientale 15x, Argentum nitricum 15x, Asafoetida 15x, Bryonia 15x, Chamomilla 15x, Cimicifuga racemosa 15x, Coffea cruda 15x, Cypripedium pubescens 15x, Gelsemium sempervirens 15x, Hyoscyamus niger 15x, Hypericum perforatum 15x, Ignatia amara 15x, Kali phosphoricum 15x, Nux vomica 15x, Sambucus nigra 15x, Strychninum 15x, Theridion 15x, Valeriana officinalis 15x.

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

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for associated 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 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Passiflora incarnata 6x, Valeriana officinalis 6x, Aconitum napellus 15x, Ambra grisea 15x, Anacardium orientale 15x, Argentum nitricum 15x, Asafoetida 15x, Bryonia 15x, Chamomilla 15x, Cimicifuga racemosa 15x, Coffea cruda 15x, Cypripedium pubescens 15x, Gelsemium sempervirens 15x, Hyoscyamus niger 15x, Hypericum perforatum 15x, Ignatia amara 15x, Kali phosphoricum 15x, Nux vomica 15x, Sambucus nigra 15x, Strychninum 15x, Theridion 15x, Valeriana officinalis 15x.

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)