Label: 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
- NDC Code(s): 44911-0430-1
- Packager: Energique, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 Label Information
Updated February 3, 2023
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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:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
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 liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0430 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA 4 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 4 [hp_X] in 1 mL GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER 4 [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 OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 12 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44911-0430-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 06/21/2017 09/30/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/21/2017 09/30/2026 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0430) , api manufacture(44911-0430) , label(44911-0430) , pack(44911-0430)