Stage 2522l

Stage 2522l
SPL v1
SPL
SPL Set ID 9d221e31-4ce6-8051-e053-2995a90abd4d
Route
ORAL
Published
Effective Date 2019-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Passiflora Incarnata Flowering Top (6 [hp_X]) Semecarpus Anacardium Juice (15 [hp_X]) Silver Cation Arsenic Cation (3+) Cypripedium Parviflorum Var. Pubescens Root Gelsemium Sempervirens Root Strychnos Ignatii Seed Carbonate Ion Lycopodium Clavatum Spore Sodium Cation Phosphorus Sambucus Nigra Flowering Top Sepia Officinalis Juice Delphinium Staphisagria Seed Datura Stramonium Lycosa Tarantula Theridion Curassavicum Valerian Aconitum Napellus
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-01-01

Description

Formulated for symptoms associated with performance anxiety such as apprehension, nausea, restlessness, trembling and over-sensitivity.

Purpose

Formulated for symptoms associated with performance anxiety such as apprehension, nausea, restlessness, trembling and over-sensitivity.


Medication Information

Purpose

Formulated for symptoms associated with performance anxiety such as apprehension, nausea, restlessness, trembling and over-sensitivity.

Description

Formulated for symptoms associated with performance anxiety such as apprehension, nausea, restlessness, trembling and over-sensitivity.

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 associated with performance anxiety such as apprehension, nausea, restlessness, trembling and over-sensitivity.

Inactive Ingredient Section

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

Indications & Usage Section

Formulated for symptoms associated with performance anxiety such as apprehension, nausea, restlessness, trembling and over-sensitivity.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as need or as directed by a health professional. Sensitive person begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Equal parts of Passiflora incarnata 6x, Valeriana officinalis 6x, Aconitum napellus 15x, Anacardium orientale 15x, Argentum nitricum 15x, Arsenicum album 15x, Cypripedium pubescens 15x, Gelsemium sempervirens 15x, Ignatia amara 15x, Kali carbonicum 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Phosphorus 15x, Sambucus nigra 15x, Sepia 15x, Staphysagria 15x, Stramonium 15x, Tarentula hispana 15x, Theridion 15x.

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 associated with performance anxiety such as apprehension, nausea, restlessness, trembling and over-sensitivity.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for symptoms associated with performance anxiety such as apprehension, nausea, restlessness, trembling and over-sensitivity.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as need or as directed by a health professional. Sensitive person begin with 1 drop 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, Anacardium orientale 15x, Argentum nitricum 15x, Arsenicum album 15x, Cypripedium pubescens 15x, Gelsemium sempervirens 15x, Ignatia amara 15x, Kali carbonicum 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Phosphorus 15x, Sambucus nigra 15x, Sepia 15x, Staphysagria 15x, Stramonium 15x, Tarentula hispana 15x, Theridion 15x.

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

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