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:
OTC DRUG
Therapeutic indications:
Bladder - Kidney  Formulated for associated symptoms such as frequent or difficult urination, burning, pain, urgency and the sensation of a full bladder. Formulated for associated symptoms such as frequent or difficult urination, burning, pain, urgency and the sensation of a full bladder.
Authorization status:
unapproved homeopathic
Authorization number:
55714-2218-0, 55714-2218-1, 55714-2218-2

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 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.

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Bladder - Kidney

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55714-2218

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

15 [hp_X]

in 1 mL

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

15 [hp_X]

in 1 mL

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

15 [hp_X]

in 1 mL

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

Lytta Vesicato ria

15 [hp_X]

in 1 mL

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

15 [hp_X]

in 1 mL

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

Equisetum Hyemale

15 [hp_X]

in 1 mL

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

UNII:9 1GQH8 I5F7)

Ferro so ferric Pho sphate

15 [hp_X]

in 1 mL

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

15 [hp_X]

in 1 mL

Juniper Berry (UNII: O8 4B519 4RL) (Juniper Berry - UNII:O8 4B519 4RL)

Juniper Berry

15 [hp_X]

in 1 mL

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

15 [hp_X]

in 1 mL

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

Pho spho rus

15 [hp_X]

in 1 mL

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

Plantago Majo r

15 [hp_X]

in 1 mL

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

Pulsatilla Vulgaris

15 [hp_X]

in 1 mL

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

Saw Palmetto

15 [hp_X]

in 1 mL

Turpentine (UNII: XJ6 RUH0 O4G) (Turpentine - UNII:XJ6 RUH0 O4G)

Turpe ntine

15 [hp_X]

in 1 mL

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

15 [hp_X]

in 1 mL

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

UNII:4N9 P6 CC1DX)

Echinacea, Unspecified

3 [hp_X]

in 1 mL

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

Go lde nse a l

3 [hp_X]

in 1 mL

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

Arctium Lappa Ro o t

3 [hp_X]

in 1 mL

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

3 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Alco ho l (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

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

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 3/0 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(55714-2218 )

Revised: 3/2011

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