Prostate 2503l

Prostate 2503l
SPL v4
SPL
SPL Set ID 9ca8f252-a14f-3990-e053-2995a90af8d7
Route
ORAL
Published
Effective Date 2025-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea, Unspecified (6 [hp_X]) Saw Palmetto (15 [hp_X]) Selenium Delphinium Staphisagria Seed Thuja Occidentalis Leafy Twig Trifolium Pratense Flower Arctium Lappa Root Solidago Virgaurea Flowering Top Strychnos Nux-vomica Seed Chondrodendron Tomentosum Root Iodine Thyroid, Unspecified Barium Cation Berberis Vulgaris Root Bark Bryonia Alba Root Oyster Shell Calcium Carbonate, Crude Cinchona Officinalis Bark Conium Maculatum Flowering Top Digitalis Ferric Cation Goldenseal Anemone Pulsatilla Lycopodium Clavatum Spore
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-01-01

Description

Formulated for associated symptoms such as discomfort, or frequent, incomplete or difficult urination and performance issues.

Purpose

Formulated for associated symptoms such as discomfort, or frequent, incomplete or difficult urination and performance issues.


Medication Information

Purpose

Formulated for associated symptoms such as discomfort, or frequent, incomplete or difficult urination and performance issues.

Description

Formulated for associated symptoms such as discomfort, or frequent, incomplete or difficult urination and performance issues.

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 discomfort, or frequent, incomplete or difficult urination and performance issues.

Inactive Ingredient Section

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

Indications & Usage Section

Formulated for associated symptoms such as discomfort, or frequent, incomplete or difficult urination and performance issues.

Dosage & Administration Section

Directions: Adults, take 6 drops by mouth one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and increase to full dose.

Otc Active Ingredient Section

Equal parts of Echinacea 6x, Hydrastis canadensis 6x, Lappa major 6x, Solidago virgaurea 6x, Baryta carbonica 15x, Berberis vulgaris 15x, Bryonia 15x, Calcarea carbonica 15x, Cinchona officinalis 15x, Conium maculatum 15x, Digitalis purpurea 15x, Ferrum picricum 15x, Hydrastis canadensis 15x, Iodium 15x, Lycopodium clavatum 15x, Nux vomica 15x, Pareira brava 15x, Pulsatilla 15x, Sabal serrulata 15x, Selenium metallicum 15x, Staphysagria 15x, Thuja occidentalis 15x, Trifolium pratense 15x, Thyroidinum 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 discomfort, or frequent, incomplete or difficult urination and performance issues.

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 associated symptoms such as discomfort, or frequent, incomplete or difficult urination and performance issues.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Adults, take 6 drops by mouth one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 6x, Hydrastis canadensis 6x, Lappa major 6x, Solidago virgaurea 6x, Baryta carbonica 15x, Berberis vulgaris 15x, Bryonia 15x, Calcarea carbonica 15x, Cinchona officinalis 15x, Conium maculatum 15x, Digitalis purpurea 15x, Ferrum picricum 15x, Hydrastis canadensis 15x, Iodium 15x, Lycopodium clavatum 15x, Nux vomica 15x, Pareira brava 15x, Pulsatilla 15x, Sabal serrulata 15x, Selenium metallicum 15x, Staphysagria 15x, Thuja occidentalis 15x, Trifolium pratense 15x, Thyroidinum 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)