ALCOSTAT- beta vulgaris, taraxacum officinale, trifolium pratense, capsicum annuum, chelidonium majus, lycopodium clavatum, nox

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

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Active ingredient:
BETA VULGARIS (UNII: 4G174V5051) (BETA VULGARIS - UNII:4G174V5051), TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375), TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828), CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG), CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN), LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479), STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919)
Available from:
Energique, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
May temporarily relieve loss of appetite, stomach upset, nausea, and craving of alcohol.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. May temporarily relieve loss of appetite, stomach upset, nausea, and craving of alcohol.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Authorization status:
unapproved homeopathic
Authorization number:
44911-0182-1

ALCOSTAT- beta vulgaris, taraxacum officinale, trifolium pratense, capsicum annuum,

chelidonium majus, lycopodium clavatum, nox vomica, quercus glandium spiritus, sulphuricum

acidum, ethylicum, saccharum officinale, 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:

(in each drop): 11.08% of Capsicum Annuum 12X, Chelidonium Majus 12X, Ethylicum 12X, 30X,

Lycopodium Clavatum 12X, Nux Vomica 12X, Quercus Glandium Spiritus 12X, Saccharum Officinale

30X, Sulphuricum Acidum 12X; 0.10% of Beta Vulgaris 3X, Taraxacum Officinale 3X, Trifolium

Pratense 3X.

INDICATIONS:

May temporarily relieve loss of appetite, stomach upset, nausea, and craving of alcohol.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA

evaluated.

WARNINGS:

If pregnant or breast-feeding, 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:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care

professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a

physician for use in children under 12 years of age.

INDICATIONS:

May temporarily relieve loss of appetite, stomach upset, nausea, and craving of alcohol.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA

evaluated.

INACTIVE INGREDIENTS:

Demineralized water, 20% Ethanol.

QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800.869.8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

ALCOSTAT

1 fl. oz. (30 ml)

ALCOSTAT

beta vulgaris, taraxacum officinale, trifolium pratense, capsicum annuum, chelidonium majus, lycopodium clavatum,

nox vomica, quercus glandium spiritus, sulphuricum acidum, ethylicum, saccharum officinale, liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:449 11-0 18 2

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BETA VULGARIS (UNII: 4G174V50 51) (BETA VULGARIS - UNII:4G174V50 51)

BETA VULGARIS

3 [hp_X]

in 1 mL

TARAXACUM O FFICINALE (UNII: 39 9 8 1FM375) (TARAXACUM OFFICINALE -

UNII:39 9 8 1FM375)

TARAXACUM

OFFICINALE

3 [hp_X]

in 1 mL

Energique, Inc.

TRIFO LIUM PRATENSE FLO WER (UNII: 4JS0 8 38 8 28 ) (TRIFOLIUM PRATENSE

FLOWER - UNII:4JS0 8 38 8 28 )

TRIFOLIUM PRATENSE

FLOWER

3 [hp_X]

in 1 mL

CAPSICUM (UNII: 0 0 UK76 46 FG) (CAPSICUM - UNII:0 0 UK76 46 FG)

CAPSICUM

12 [hp_X]

in 1 mL

CHELIDO NIUM MAJUS (UNII: 7E8 8 9 U5RNN) (CHELIDONIUM MAJUS -

UNII:7E8 8 9 U5RNN)

CHELIDONIUM MAJUS

12 [hp_X]

in 1 mL

LYCO PO DIUM CLAVATUM SPO RE (UNII: C8 8 X29 Y479 ) (LYCOPODIUM CLAVATUM

SPORE - UNII:C8 8 X29 Y479 )

LYCOPODIUM

CLAVATUM SPORE

12 [hp_X]

in 1 mL

STRYCHNO S NUX-VO MICA SEED (UNII: 26 9 XH139 19 ) (STRYCHNOS NUX-VOMICA

SEED - UNII:26 9 XH139 19 )

STRYCHNOS NUX-

VOMICA SEED

12 [hp_X]

in 1 mL

Q UERCUS RO BUR NUT (UNII: Q7MU1F4GLY) (QUERCUS ROBUR NUT -

UNII:Q7MU1F4GLY)

QUERCUS ROBUR NUT

12 [hp_X]

in 1 mL

SULFURIC ACID (UNII: O40 UQP6 WCF) (SULFURIC ACID - UNII:O40 UQP6 WCF)

SULFURIC ACID

12 [hp_X]

in 1 mL

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

12 [hp_X]

in 1 mL

SUCRO SE (UNII: C151H8 M554) (SUCROSE - UNII:C151H8 M554)

SUCROSE

30 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:449 11-

0 18 2-1

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

Pro duc t

0 7/0 5/20 19

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 7/0 8 /20 15

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 18 2) , api manufacture(449 11-0 18 2) , label(449 11-0 18 2) , pack(449 11-

0 18 2)

Revised: 7/2019

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