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Prostate

Newton Laboratories, Inc.
Newton Laboratories, Inc.

Prostate


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 - 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%. 

QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256 

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. 

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.

PACKAGE LABEL

Prostate

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

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55714-2242
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
THYROID, UNSPECIFIED THYROID, UNSPECIFIED 15 [hp_X]
BARIUM CARBONATE BARIUM CATION 10 [hp_X]
BERBERIS VULGARIS ROOT BARK BERBERIS VULGARIS ROOT BARK 10 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 10 [hp_X]
OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X]
Cinchona Officinalis Bark Cinchona Officinalis Bark 10 [hp_X]
Conium Maculatum Flowering Top CONIUM MACULATUM FLOWERING TOP 10 [hp_X]
Digitalis DIGITALIS 10 [hp_X]
FERRIC PICRATE Ferric Cation 10 [hp_X]
GOLDENSEAL GOLDENSEAL 10 [hp_X]
Iodine IODINE 10 [hp_X]
Lycopodium Clavatum Spore LYCOPODIUM CLAVATUM SPORE 10 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 10 [hp_X]
CHONDRODENDRON TOMENTOSUM ROOT CHONDRODENDRON TOMENTOSUM ROOT 10 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 10 [hp_X]
SAW PALMETTO SAW PALMETTO 10 [hp_X]
Selenium SELENIUM 10 [hp_X]
DELPHINIUM STAPHISAGRIA SEED DELPHINIUM STAPHISAGRIA SEED 10 [hp_X]
THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG 10 [hp_X]
TRIFOLIUM PRATENSE FLOWER 10 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 3 [hp_X]
ARCTIUM LAPPA ROOT ARCTIUM LAPPA ROOT 3 [hp_X]
SOLIDAGO VIRGAUREA FLOWERING TOP SOLIDAGO VIRGAUREA FLOWERING TOP 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-2242-1 29.57 in 1 BOTTLE, GLASS
2 NDC:55714-2242-2 59.14 in 1 BOTTLE, GLASS
3 NDC:55714-2242-0 .5 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-03-01


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