Bladder 4467P-Dis

Drug Labeling and Warnings

Drug Details [pdf]

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 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.

----------

Bladder 4467P-Dis

INDICATIONS & USAGE SECTION

BLADDER - KIDNEY   Formulated for symptoms associated with urinary tract infections, renal lithiasis and other kidney or bladder dysfunction.    

DOSAGE & ADMINISTRATION SECTION

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional.  Under age 2, crush or dissolve pellets in purified water.    

ACTIVE INGREDIENT SECTION

Apis mel. 20x, Berber. vulg. 20x, Bryonia 20x, Cantharis 20x, Cinchona 20x, Equisetum hyemale 20x, Ferrum phosphoricum 20x, Gelsemium 20x, Juniperus com. 20x, Pareira 20x, Phosphorus 20x, Plantago 20x, Pulsatilla 20x, Sabal 20x, Terebinthina 20x, Uva-ursi 20x, Echinacea 8x, Hydrastis 8x, Lappa 8x, Solidago 8x, Echinacea 3x, Hydrastis 3x, Lappa 3x, Solidago 3x.         

PURPOSE SECTION

Formulated for symptoms associated with urinary tract infections, renal lithiasis and other kidney or bladder 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.  

PREGNANCY OR BREAST FEEDING SECTION

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

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 pellet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 55714-4467
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
JUNIPER BERRY (UNII: O84B5194RL) (JUNIPER BERRY - UNII:O84B5194RL)	JUNIPER BERRY	20 [hp_X]  in 1 g
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	20 [hp_X]  in 1 g
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	20 [hp_X]  in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	20 [hp_X]  in 1 g
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	20 [hp_X]  in 1 g
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	20 [hp_X]  in 1 g
EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25)	EQUISETUM HYEMALE	20 [hp_X]  in 1 g
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	20 [hp_X]  in 1 g
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	20 [hp_X]  in 1 g
CHONDRODENDRON TOMENTOSUM ROOT (UNII: 395A3P448Z) (CHONDRODENDRON TOMENTOSUM ROOT - UNII:395A3P448Z)	CHONDRODENDRON TOMENTOSUM ROOT	20 [hp_X]  in 1 g
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	20 [hp_X]  in 1 g
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	20 [hp_X]  in 1 g
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	20 [hp_X]  in 1 g
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS)	SAW PALMETTO	20 [hp_X]  in 1 g
TURPENTINE OIL (UNII: C5H0QJ6V7F) (TURPENTINE OIL - UNII:C5H0QJ6V7F)	TURPENTINE OIL	20 [hp_X]  in 1 g
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) (ARCTOSTAPHYLOS UVA-URSI LEAF - UNII:3M5V3D1X36)	ARCTOSTAPHYLOS UVA-URSI LEAF	20 [hp_X]  in 1 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	8 [hp_X]  in 1 g
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	8 [hp_X]  in 1 g
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3)	ARCTIUM LAPPA ROOT	8 [hp_X]  in 1 g
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	8 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-4467-1	28.35 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	06/01/2011	01/31/2019
2	NDC: 55714-4467-2	56.7 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	06/01/2011	01/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/01/2011	01/31/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	manufacture(55714-4467)

Revised: 10/2019

Document Id: 963bced6-197b-fed8-e053-2a95a90accac

34391-3

Set id: a9cdad4c-c953-35cf-972b-174b1f598758

Version: 2

Effective Time: 20191031