BLADDER - KIDNEY - apis mellifera, berberis vulgaris root bark, bryonia alba root, lytta vesicatoria, cinchona officinalis bark, equisetum hyemale, ferrosoferric phosphate, gelsemium sempervirens root, juniper berry, chondrodendron tomentosum root, phosphorus, plantago major, pulsatilla vulgaris, saw palmetto, turpentine, arctostaphylos uva-ursi leaf, echinacea, unspecified, goldenseal, arctium lappa root and solidago virgaurea flowering top liquid
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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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INDICATIONS & USAGE SECTION

Bladder - Kidney Formulated for associated symptoms such as frequent or difficult urination, burning, pain, urgency and the sensation of a full bladder.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) 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

Apis mel. 15x, Berber. vulg. 15x, Bryonia 15x, Cantharis 15x, Cinchona 15x, Equisetum hyemale 15x, Ferrum phosphoricum 15x, Gelsemium 15x, Juniperus com. 15x, Pareira 15x, Phosphorus 15x, Plantago 15x, Pulsatilla 15x, Sabal 15x, Terebinthina 15x, Uva-ursi 15x, Echinacea 3x, Hydrastis 3x, Lappa 3x, Solidago 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as frequent or difficult urination, burning, pain, urgency and the sensation of a full bladder.

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

BLADDER - KIDNEY
apis mel., berber. vulg., bryonia, cantharis, cinchona, equisetum hyemale, ferrum phosphoricum, gelsemium, juniperus com., pareira, phosphorus, plantago, pulsatilla, sabal, terebinthina, uva-ursi, echinacea, hydrastis, lappa, solidago liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2218
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Apis Mellifera (Apis Mellifera)	Apis Mellifera	15 [hp_X] in 1 mL
Berberis Vulgaris Root Bark (Berberis Vulgaris Root Bark)	Berberis Vulgaris Root Bark	15 [hp_X] in 1 mL
Bryonia Alba Root (Bryonia Alba Root)	Bryonia Alba Root	15 [hp_X] in 1 mL
Lytta Vesicatoria (Lytta Vesicatoria)	Lytta Vesicatoria	15 [hp_X] in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark)	Cinchona Officinalis Bark	15 [hp_X] in 1 mL
Equisetum Hyemale (Equisetum Hyemale)	Equisetum Hyemale	15 [hp_X] in 1 mL
Ferrosoferric Phosphate (Ferrosoferric Phosphate)	Ferrosoferric Phosphate	15 [hp_X] in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root)	Gelsemium Sempervirens Root	15 [hp_X] in 1 mL
Juniper Berry (Juniper Berry)	Juniper Berry	15 [hp_X] in 1 mL
Chondrodendron Tomentosum Root (Chondrodendron Tomentosum Root)	Chondrodendron Tomentosum Root	15 [hp_X] in 1 mL
Phosphorus (Phosphorus)	Phosphorus	15 [hp_X] in 1 mL
Plantago Major (Plantago Major)	Plantago Major	15 [hp_X] in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris)	Pulsatilla Vulgaris	15 [hp_X] in 1 mL
Saw Palmetto (Saw Palmetto)	Saw Palmetto	15 [hp_X] in 1 mL
Turpentine (Turpentine)	Turpentine	15 [hp_X] in 1 mL
Arctostaphylos Uva-ursi Leaf (Arctostaphylos Uva-ursi Leaf)	Arctostaphylos Uva-ursi Leaf	15 [hp_X] in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified)	Echinacea, Unspecified	3 [hp_X] in 1 mL
Goldenseal (Goldenseal)	Goldenseal	3 [hp_X] in 1 mL
Arctium Lappa Root (Arctium Lappa Root)	Arctium Lappa Root	3 [hp_X] in 1 mL
Solidago Virgaurea Flowering Top (Solidago Virgaurea Flowering Top)	Solidago Virgaurea Flowering Top	3 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol

Packaging
#	Item Code	Package Description
1	NDC:55714-2218-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-2218-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-2218-0	.5 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-2218), API MANUFACTURE(55714-2218)

Revised: 03/2011

Document Id: 56d98a58-ee9e-5bb1-a339-52aa701342f8

Set id: 449c2bb1-4265-4a31-6a6f-20882923601d

Version: 1

Effective Time: 20110301

Newton Laboratories, Inc.