BLADDER - KIDNEY - apis mel., berber. vulg., bryonia, cantharis, cinchona, equisetum hyemale, ferrum phosphoricum, gelsemium, ju

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z), Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U), Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B), Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT), Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB), Equisetum Hyemale (UNII: 59677RXH25) (Equisetum Hyemale - UNII:59677RXH25), Ferrosoferric Phosphate (U
Available from:
Newton Laboratories, Inc.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
BLADDER - KIDNEY    Formulated for symptoms associated with urinary tract infections, renal lithiasis and other kidney or bladder dysfunction.     Formulated for symptoms associated with urinary tract infections, renal lithiasis and other kidney or bladder dysfunction. 
Authorization status:
unapproved homeopathic
Authorization number:
55714-4467-1, 55714-4467-2

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.

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Bladder - Kidney

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 T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:55714-446 7

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Apis Mellifera (UNII: 7S8 2P3R43Z) (Apis Mellifera - UNII:7S8 2P3R43Z)

Apis Mellifera

20 [hp_X]

in 1 g

Berberis Vulg a ris Ro o t Ba rk (UNII: 1TH8 Q20 J0 U) (Berberis Vulgaris Ro o t Bark -

UNII:1TH8 Q20 J0 U)

Berberis Vulgaris Ro o t

Ba rk

20 [hp_X]

in 1 g

Bryo nia Alba Ro o t (UNII: T7J0 46 YI2B) (Bryo nia Alba Ro o t - UNII:T7J0 46 YI2B)

Bryo nia Alba Ro o t

20 [hp_X]

in 1 g

Lytta Vesica to ria (UNII: 3Q0 34RO3BT) (Lytta Vesicato ria - UNII:3Q0 34RO3BT)

Lytta Vesicato ria

20 [hp_X]

in 1 g

Cincho na O fficina lis Ba rk (UNII: S0 0 3A158 SB) (Cincho na Officinalis Bark -

UNII:S0 0 3A158 SB)

Cincho na Officinalis Bark

20 [hp_X]

in 1 g

20 [hp_X]

Equisetum Hyema le (UNII: 59 6 77RXH25) (Equisetum Hyemale - UNII:59 6 77RXH25)

Equisetum Hyemale

20 [hp_X]

in 1 g

Ferro so ferric Pho spha te (UNII: 9 1GQH8 I5F7) (Ferro so ferric Pho sphate -

UNII:9 1GQH8 I5F7)

Ferro so ferric Pho sphate

20 [hp_X]

in 1 g

Gelsemium Sempervirens Ro o t (UNII: 6 39 KR6 0 Q1Q) (Gelsemium Sempervirens Ro o t -

UNII:6 39 KR6 0 Q1Q)

Gelsemium Sempervirens

Ro o t

20 [hp_X]

in 1 g

Juniperus Co mmunis Fruit (UNII: O8 4B519 4RL) (Juniperus Co mmunis Fruit -

UNII:O8 4B519 4RL)

Juniperus Co mmunis Fruit

20 [hp_X]

in 1 g

Cho ndro dendro n To mento sum Ro o t (UNII: 39 5A3P448 Z) (Cho ndro dendro n

To mento sum Ro o t - UNII:39 5A3P448 Z)

Cho ndro de ndro n

To mento sum Ro o t

20 [hp_X]

in 1 g

Pho spho rus (UNII: 27YLU75U4W) (Pho spho rus - UNII:27YLU75U4W)

Pho spho rus

20 [hp_X]

in 1 g

Pla nta g o Ma j o r (UNII: W246 9 WNO6 U) (Plantago Majo r - UNII:W246 9 WNO6 U)

Plantago Majo r

20 [hp_X]

in 1 g

Pulsa tilla Vulg a ris (UNII: I76 KB35JEV) (Pulsatilla Vulgaris - UNII:I76 KB35JEV)

Pulsatilla Vulgaris

20 [hp_X]

in 1 g

Sa w Pa lmetto (UNII: J7WWH9 M8 QS) (Saw Palmetto - UNII:J7WWH9 M8 QS)

Saw Palmetto

20 [hp_X]

in 1 g

Turpentine O il (UNII: C5H0 QJ6 V7F) (Turpentine Oil - UNII:C5H0 QJ6 V7F)

Turpentine Oil

20 [hp_X]

in 1 g

Arcto sta phylo s Uva -ursi Lea f (UNII: 3M5V3D1X36 ) (Arcto staphylo s Uva-ursi Leaf -

UNII:3M5V3D1X36 )

Arcto staphylo s Uva-ursi

Le a f

20 [hp_X]

in 1 g

Echina cea , Unspecified (UNII: 4N9 P6 CC1DX) (Echinacea, Unspecified -

UNII:4N9 P6 CC1DX)

Echinacea, Unspecified

8 [hp_X]

in 1 g

Go ldensea l (UNII: ZW3Z11D0 JV) (Go ldenseal - UNII:ZW3Z11D0 JV)

Go lde nse a l

8 [hp_X]

in 1 g

Arctium La ppa Ro o t (UNII: 59 7E9 BI3Z3) (Arctium Lappa Ro o t - UNII:59 7E9 BI3Z3)

Arctium Lappa Ro o t

8 [hp_X]

in 1 g

So lida g o Virg a urea Flo wering To p (UNII: 540 5K23S50 ) (So lidago Virgaurea Flo wering

To p - UNII:540 5K23S50 )

So lidago Virgaurea

Flo wering To p

8 [hp_X]

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Sucro se (UNII: C151H8 M554)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55714-446 7-1

28 .35 g in 1 BOTTLE, GLASS

2

NDC:55714-446 7-2

56 .7 g in 1 BOTTLE, GLASS

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 6 /0 1/20 11

Labeler -

Newton Laboratories, Inc. (788793610)

Registrant -

Newton Laboratories, Inc. (788793610)

Establishment

Newton Laboratories, Inc.

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Newto n Labo rato ries, Inc.

78 8 79 36 10

MANUFACTURE(55714-446 7)

Revised: 6/2011

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