Label: 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
- NDC Code(s): 44911-0670-1
- 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 April 5, 2023
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- ACTIVE INGREDIENTS:
- PURPOSE:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
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INGREDIENTS AND APPEARANCE
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 liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0670 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44911-0670-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 04/05/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/05/2023 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0670) , api manufacture(44911-0670) , label(44911-0670) , pack(44911-0670)