GENSTAT- aesculus hippocastanum, equisetum hyemale, fumaria officinalis, hydrocotyle asiatica, oleum olea europaea, ononis spino

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

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Active ingredient:
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ), EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25), FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL) (FUMARIA OFFICINALIS FLOWERING TOP - UNII:VH659J61ZL), CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U), OLIVE OIL (UNII: 6UYK2W1W1E) (OLIVE OIL - UNII:6UYK2W1W1E), ONONIS SPINOSA WHOLE (UNII: RP8496915M) (ONONIS CAMPESTRIS - UNII:RP8496915M), PASSIFLORA INCARNATA FLOWERING TOP (UNII: C
Available from:
Energique, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sudden desire to urinate, lowered metabolism, cough, dry and croupy, abdominal bloating, constipation alternating with diarrhea, muscle stiffness, soreness, pain and general detoxifications.** **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration. Sudden desire to urinate, lowered metabolism, cough, dry and croupy, abdominal bloating, constipation alternating with diarrhea, muscle stiffness, soreness, pain and general detoxifications.** **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
Authorization status:
unapproved homeopathic
Authorization number:
44911-0315-1

GENSTAT- aesculus hippocastanum, equisetum hyemale, fumaria officinalis, hydrocotyle

asiatica, oleum olea europaea, ononis spinosa, passiflora incarnata, robes nigrum, solidago

virgaurea liquid

Energique, 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.

----------

Drug Facts:

ACTIVE INGREDIENTS:

Aesculus Hippocastanum 6X, Equisetum Hyemale 6X, Fumaria Officinalis 6X, Hydrocotyle Asiatica

6X, Oleum Olea Europaea 6X, Ononis Spinosa 6X, Passiflora Incarnata 6X, Robes Nigrum 6X,

Solidago Virgaurea 6X.

INDICATIONS:

Sudden desire to urinate, lowered metabolism, cough, dry and croupy, abdominal bloating, constipation

alternating with diarrhea, muscle stiffness, soreness, pain and general detoxifications.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by

the Food and Drug Administration.

WARNINGS:

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control

Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control

Center right away.

DIRECTIONS:

4 to 5 droppersful in a glass of juice before breakfast.

INDICATIONS:

Sudden desire to urinate, lowered metabolism, cough, dry and croupy, abdominal bloating, constipation

alternating with diarrhea, muscle stiffness, soreness, pain and general detoxifications.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by

the Food and Drug Administration.

INACTIVE INGREDIENTS:

Citric acid, Demineralized water, Magnesium chloride, Potassium sorbate.

QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579 800.868.8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

GENSTAT

4 fl. oz. (120 ml)

GENSTAT

aesculus hippocastanum, equisetum hyemale, fumaria officinalis, hydrocotyle asiatica, oleum olea europaea, ononis

spinosa, passiflora incarnata, robes nigrum, solidago virgaurea liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:449 11-0 315

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HO RSE CHESTNUT (UNII: 3C18 L6 RJAZ) (HORSE CHESTNUT - UNII:3C18 L6 RJAZ)

HORSE CHESTNUT

6 [hp_X]

in 1 mL

EQ UISETUM HYEMALE (UNII: 59 6 77RXH25) (EQUISETUM HYEMALE -

UNII:59 6 77RXH25)

EQUISETUM HYEMALE

6 [hp_X]

in 1 mL

FUMARIA O FFICINALIS FLO WERING TO P (UNII: VH6 59 J6 1ZL) (FUMARIA

OFFICINALIS FLOWERING TOP - UNII:VH6 59 J6 1ZL)

FUMARIA OFFICINALIS

FLOWERING TOP

6 [hp_X]

in 1 mL

Energique, Inc.

CENTELLA ASIATICA (UNII: 7M8 6 7G6 T1U) (CENTELLA ASIATICA -

UNII:7M8 6 7G6 T1U)

CENTELLA ASIATICA

6 [hp_X]

in 1 mL

O LIVE O IL (UNII: 6 UYK2W1W1E) (OLIVE OIL - UNII:6 UYK2W1W1E)

OLIVE OIL

6 [hp_X]

in 1 mL

O NO NIS SPINO SA WHO LE (UNII: RP8 49 6 9 15M) (ONONIS CAMPESTRIS -

UNII:RP8 49 6 9 15M)

ONONIS SPINOSA WHOLE

6 [hp_X]

in 1 mL

PASSIFLO RA INCARNATA FLO WERING TO P (UNII: CLF5YFS11O) (PASSIFLORA

INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)

PASSIFLORA INCARNATA

FLOWERING TOP

6 [hp_X]

in 1 mL

BLACK CURRANT (UNII: 9 755T40 D11) (BLACK CURRANT - UNII:9 755T40 D11)

BLACK CURRANT

6 [hp_X]

in 1 mL

SO LIDAGO VIRGAUREA FLO WERING TO P (UNII: 540 5K23S50 ) (SOLIDAGO

VIRGAUREA FLOWERING TOP - UNII:540 5K23S50 )

SOLIDAGO VIRGAUREA

FLOWERING TOP

6 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

MAGNESIUM CHLO RIDE (UNII: 0 2F3473H9 O)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:449 11-

0 315-1

120 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/28 /20 16

0 5/25/20 21

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 4/28 /20 16

0 5/25/20 21

Labeler -

Energique, Inc. (789886132)

Registrant -

Apotheca Company (844330915)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo the c a

Co mpany

8 44330 9 15

manufacture(449 11-0 315) , api manufacture(449 11-0 315) , label(449 11-0 315) , pack(449 11-

0 315)

Revised: 12/2016

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