Stage 2595l

Stage 2595l
SPL v1
SPL
SPL Set ID 2df84360-dfff-9851-e063-6394a90ad790
Route
ORAL
Published
Effective Date 2025-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-02-11

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

Inactive Ingredients: 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 needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Active Ingredients: Equal parts of Passiflora 6x, Valeriana 6x, Aconitum nap. 15x, Anacardium 15x, Arg. nit. 15x, Arsenicum alb. 15x, Cypripedium 15x, Gelsemium 15x, Ignatia 15x, Kali carb.15x, Lycopodium 15x, Nat. mur. 15x, Phos. 15x, Sambucus nig. 15x, Sepia 15x, Staphysag. 15x, Stramonium 15x, Tarentula hisp. 15x, Theridion 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 symptoms associated with performance anxiety such as apprehension, nausea, restlessness, trembling and over-sensitivity.

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 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 needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Active Ingredients: Equal parts of Passiflora 6x, Valeriana 6x, Aconitum nap. 15x, Anacardium 15x, Arg. nit. 15x, Arsenicum alb. 15x, Cypripedium 15x, Gelsemium 15x, Ignatia 15x, Kali carb.15x, Lycopodium 15x, Nat. mur. 15x, Phos. 15x, Sambucus nig. 15x, Sepia 15x, Staphysag. 15x, Stramonium 15x, Tarentula hisp. 15x, Theridion 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)