Prostate 2243P

Drug Labeling and Warnings

Drug Details [pdf]

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 pellet 
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Prostate 2243P

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions:  Adults, take 6 pellets orally one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 pellet 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: Gluten-free, non-GMO, beet-derived sucrose pellets. 

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

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 pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55714-2243
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED15 [hp_X]  in 1 g
BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE10 [hp_X]  in 1 g
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK10 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT10 [hp_X]  in 1 g
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]  in 1 g
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK10 [hp_X]  in 1 g
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP10 [hp_X]  in 1 g
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS10 [hp_X]  in 1 g
FERRIC PICRATE (UNII: KZM8ZRY36A) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION10 [hp_X]  in 1 g
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL10 [hp_X]  in 1 g
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE10 [hp_X]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE10 [hp_X]  in 1 g
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED10 [hp_X]  in 1 g
CHONDRODENDRON TOMENTOSUM ROOT (UNII: 395A3P448Z) (CHONDRODENDRON TOMENTOSUM ROOT - UNII:395A3P448Z) CHONDRODENDRON TOMENTOSUM ROOT10 [hp_X]  in 1 g
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS10 [hp_X]  in 1 g
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO10 [hp_X]  in 1 g
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM10 [hp_X]  in 1 g
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED10 [hp_X]  in 1 g
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG10 [hp_X]  in 1 g
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER10 [hp_X]  in 1 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED3 [hp_X]  in 1 g
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT3 [hp_X]  in 1 g
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55714-2243-128.35 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
2NDC: 55714-2243-256.7 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
3NDC: 55714-2243-07.08 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/01/201101/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/201101/31/2019
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-2243)

Revised: 1/2019