GLUTENSTAT- alfalfa, zingiber officinale, cinchona officinalis, hydrastis canadensis, barley (grain), carbo vegetabilis, glyphosate, lycopodium clavatum, natrum muriaticum, nux vomica, oat (grain), pulsatilla (vulgaris), rye (grain), wheat (grain), gluten 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.

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DRUG FACTS:

ACTIVE INGREDIENTS:

(in each drop): 6.67% of Alfalfa 4X, Barley 12X, Carbo Vegetabilis 12X, Cinchona Officinalis 4X, Gluten 16X, Glyphosate 12X, Hydrastis Canadensis 6X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Nux Vomica 12X, Oat 12X, Pulsatilla 12X, Rye 12X, Wheat 12X, Zingiber Officinale 4X.

PURPOSE:

May temporarily relieve symptoms of bloating, abdominal pain, alternating constipation and diarrhea, poor digestion and brain fog.**

**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 cool, dry place.

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 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 symptoms of bloating, abdominal pain, alternating constipation and diarrhea, poor digestion and brain fog.**

**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

GLUTENSTAT

1 fl. oz. (30 ml)

GLUTENSTAT

GLUTENSTAT
alfalfa, zingiber officinale, cinchona officinalis, hydrastis canadensis, barley (grain), carbo vegetabilis, glyphosate, lycopodium clavatum, natrum muriaticum, nux vomica, oat (grain), pulsatilla (vulgaris), rye (grain), wheat (grain), gluten liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:44911-0670
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD)	MEDICAGO SATIVA WHOLE	4 [hp_X] in 1 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	4 [hp_X] in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	6 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X] in 1 mL
BARLEY (UNII: 5PWM7YLI7R) (BARLEY - UNII:5PWM7YLI7R)	BARLEY	12 [hp_X] in 1 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	12 [hp_X] in 1 mL
GLYPHOSATE (UNII: 4632WW1X5A) (GLYPHOSATE - UNII:4632WW1X5A)	GLYPHOSATE	12 [hp_X] in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	12 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X] in 1 mL
OAT (UNII: Z6J799EAJK) (OAT - UNII:Z6J799EAJK)	OAT	12 [hp_X] in 1 mL
PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	PULSATILLA VULGARIS WHOLE	12 [hp_X] in 1 mL
RYE (UNII: 0R4AQI398X) (RYE - UNII:0R4AQI398X)	RYE	12 [hp_X] in 1 mL
WHEAT (UNII: 4J2I0SN84Y) (WHEAT - UNII:4J2I0SN84Y)	WHEAT	12 [hp_X] in 1 mL
WHEAT GLUTEN (UNII: 1534K8653J) (WHEAT GLUTEN - UNII:1534K8653J)	WHEAT GLUTEN	16 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:44911-0670-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/05/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/05/2023

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(44911-0670) , api manufacture(44911-0670) , label(44911-0670) , pack(44911-0670)

Revised: 4/2023

Document Id: 4884ad84-694d-41dc-9946-63e1cf2696b7

Set id: c6b867b6-74d9-4725-90d7-7d5d1fe61121

Version: 1

Effective Time: 20230405

Energique, Inc.