prostate

prostate
SPL v1
SPL
SPL Set ID a8cd200a-3616-2399-9211-0f2c50d71e00
Route
oral
Published
Effective Date 2012-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
thyroid, unspecified (15 [hp_X]) barium cation (10 [hp_X]) berberis vulgaris root bark (3 [hp_X]) bryonia alba root oyster shell calcium carbonate, crude cinchona officinalis bark conium maculatum flowering top digitalis ferric cation goldenseal iodine lycopodium clavatum spore strychnos nux-vomica seed chondrodendron tomentosum root pulsatilla vulgaris saw palmetto selenium delphinium staphisagria seed thuja occidentalis leafy twig trifolium pratense flower echinacea, unspecified arctium lappa root solidago virgaurea flowering top
Inactive Ingredients
alcohol

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2011-03-01

Purpose

Formulated for associated symptoms such as enlargement, discomfort, frequent, incomplete or difficult urination and sexual dysfunction.

Description

Prostate    Formulated for associated symptoms such as enlargement, discomfort, frequent, incomplete or difficult urination and sexual dysfunction.


Medication Information

Purpose

Formulated for associated symptoms such as enlargement, discomfort, frequent, incomplete or difficult urination and sexual dysfunction.

Description

Prostate    Formulated for associated symptoms such as enlargement, discomfort, frequent, incomplete or difficult urination and sexual dysfunction.

Package Label

Warnings Section

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children. 

Questions Section

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256 

Otc Purpose Section

Formulated for associated symptoms such as enlargement, discomfort, frequent, incomplete or difficult urination and sexual dysfunction.

Inactive Ingredient Section

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

Indications & Usage Section

Prostate    Formulated for associated symptoms such as enlargement, discomfort, frequent, incomplete or difficult urination and sexual dysfunction.

Dosage & Administration Section

Directions: ORAL USE ONLY - SHAKE WELL.  Adults, take 6 drops orally one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Thyroidinum 15x, Baryta carb. 10x, Berber. vulg. 10x, Bryonia 10x, Calc. carb. 10x, Cinchona 10x,Conium 10x, Digitalis 10x, Ferrum picricum 10x, Hydrastis 10x, Iodium 10x, Lycopodium 10x, Nux vom. 10x, Pareira 10x, Pulsatilla 10x, Sabal 10x, Selenium 10x, Staphysag. 10x, Thuja occ. 10x, Trifolium pratense 10x, Echinacea 3x, Hydrastis 3x, Lappa 3x, Solidago 3x.

Otc Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

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)

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children. 

Questions Section (QUESTIONS SECTION)

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256 

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for associated symptoms such as enlargement, discomfort, frequent, incomplete or difficult urination and sexual dysfunction.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Prostate    Formulated for associated symptoms such as enlargement, discomfort, frequent, incomplete or difficult urination and sexual dysfunction.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: ORAL USE ONLY - SHAKE WELL.  Adults, take 6 drops orally one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Thyroidinum 15x, Baryta carb. 10x, Berber. vulg. 10x, Bryonia 10x, Calc. carb. 10x, Cinchona 10x,Conium 10x, Digitalis 10x, Ferrum picricum 10x, Hydrastis 10x, Iodium 10x, Lycopodium 10x, Nux vom. 10x, Pareira 10x, Pulsatilla 10x, Sabal 10x, Selenium 10x, Staphysag. 10x, Thuja occ. 10x, Trifolium pratense 10x, Echinacea 3x, Hydrastis 3x, Lappa 3x, Solidago 3x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

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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