GLUTENSTAT- alfalfa, cinchona officinalis, zingiber officinale, 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 (Grain) 12X, Carbo Vegetabilis 12X, Cinchona Officinalis 4X, Gluten 16X, Glyphosate 12X, Hydrastis Canadensis 6X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Nux Vomica 12X, Oat (Grain) 12X, Pulsatilla (Vulgaris) 12X, Rye (Grain) 12X, Wheat (Grain) 12X, Zingiber Officinale 4X.

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.

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:

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, cinchona officinalis, zingiber officinale, 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0430
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA4 [hp_X]  in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK4 [hp_X]  in 1 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER4 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
BARLEY (UNII: 5PWM7YLI7R) (BARLEY - UNII:5PWM7YLI7R) BARLEY12 [hp_X]  in 1 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL12 [hp_X]  in 1 mL
GLYPHOSATE (UNII: 4632WW1X5A) (GLYPHOSATE - UNII:4632WW1X5A) GLYPHOSATE12 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE12 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 1 mL
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL12 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA12 [hp_X]  in 1 mL
RYE (UNII: 0R4AQI398X) (RYE - UNII:0R4AQI398X) RYE12 [hp_X]  in 1 mL
WHEAT (UNII: 4J2I0SN84Y) (WHEAT - UNII:4J2I0SN84Y) WHEAT12 [hp_X]  in 1 mL
WHEAT GLUTEN (UNII: 1534K8653J) (WHEAT GLUTEN - UNII:1534K8653J) WHEAT GLUTEN16 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44911-0430-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/21/201709/30/2026
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/21/201709/30/2026
Labeler - Energique, Inc. (789886132)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(44911-0430) , api manufacture(44911-0430) , label(44911-0430) , pack(44911-0430)

Revised: 2/2023
Document Id: 272661c5-f5fe-4d09-9e7e-aea49022f4dd
Set id: 314c8276-dc9b-4654-8e0e-3b4c22db5b21
Version: 3
Effective Time: 20230203
 
Energique, Inc.