Label: GRAIN AND SEED ANTIGENS- amaranth, bamboo, barley, buckwheat, corn, flax seed, lentils, millet, milo, oat, poppy seed, rice, rye, sesame, soybean, sugarcane, sunflower seed, wheat, arsenicum album, lycopodium clavatum, natrum muriaticum, sulphur liquid
- NDC Code(s): 43857-0635-1
- Packager: BioActive Nutritional, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CII
- 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 June 20, 2023
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ACTIVE INGREDIENTS:
Amaranth 9X, 12X, 15X, 30X, Bamboo 9X, 12X, 15X, 30X Barley 9X, 12X, 15X, 30X, Buckwheat 9X, 12X, 15X, 30X, Corn 9X, 12X, 15X, 30X, Flax Seed 9X, 12X, 15X, 30X, Lentils 9X, 12X, 15X, 30X, Millet 9X, 12X, 15X, 30X, Milo 9X, 12X, 15X, 30X, Oat 9X, 12X, 15X, 30X, Poppy Seed 9X, 12X, 15X, 30X, Rice 9X, 12X, 15X, 30X, Rye 9X, 12X, 15X, 30X, Sesame 9X, 12X, 15X, 30X, Soybean 9X, 12X, 15X, 30X, Sugarcane 9X, 12X, 15X, 30X, Sunflower Seed 9X, 12X, 15X, 30X, Wheat 9X, 12X, 15X, 30X, Arsenicum Album 12X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Sulphur 12X.
- PURPOSE:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
GRAIN AND SEED ANTIGENS
amaranth, bamboo, barley, buckwheat, corn, flax seed, lentils, millet, milo, oat, poppy seed, rice, rye, sesame, soybean, sugarcane, sunflower seed, wheat, arsenicum album, lycopodium clavatum, natrum muriaticum, sulphur liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0635 Route of Administration ORAL DEA Schedule CII Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS CRUENTUS SEED (UNII: 0C5WAA83X5) (AMARANTHUS CRUENTUS SEED - UNII:0C5WAA83X5) AMARANTHUS CRUENTUS SEED 9 [hp_X] in 1 mL BAMBUSA VULGARIS STEM (UNII: SMR633LHTC) (BAMBUSA VULGARIS STEM - UNII:SMR633LHTC) BAMBUSA VULGARIS STEM 9 [hp_X] in 1 mL BARLEY (UNII: 5PWM7YLI7R) (BARLEY - UNII:5PWM7YLI7R) BARLEY 9 [hp_X] in 1 mL BUCKWHEAT (UNII: N0Y68724R3) (BUCKWHEAT - UNII:N0Y68724R3) BUCKWHEAT 9 [hp_X] in 1 mL CORN (UNII: 0N8672707O) (CORN - UNII:0N8672707O) CORN 9 [hp_X] in 1 mL FLAX SEED (UNII: 4110YT348C) (FLAX SEED - UNII:4110YT348C) FLAX SEED 9 [hp_X] in 1 mL LENTIL (UNII: 6O38V6B52O) (LENTIL - UNII:6O38V6B52O) LENTIL 9 [hp_X] in 1 mL MILLET (UNII: TJR6B3R47P) (MILLET - UNII:TJR6B3R47P) MILLET 9 [hp_X] in 1 mL SORGHUM BICOLOR WHOLE (UNII: Y3T98X3AL6) (SORGHUM BICOLOR WHOLE - UNII:Y3T98X3AL6) SORGHUM BICOLOR WHOLE 9 [hp_X] in 1 mL OAT (UNII: Z6J799EAJK) (OAT - UNII:Z6J799EAJK) OAT 9 [hp_X] in 1 mL POPPY SEED (UNII: 60RO23IR87) (POPPY SEED - UNII:60RO23IR87) POPPY SEED 9 [hp_X] in 1 mL WHITE RICE (UNII: A195V20H7A) (WHITE RICE - UNII:A195V20H7A) WHITE RICE 9 [hp_X] in 1 mL RYE (UNII: 0R4AQI398X) (RYE - UNII:0R4AQI398X) RYE 9 [hp_X] in 1 mL SESAME SEED (UNII: 7Y1255HVXR) (SESAME SEED - UNII:7Y1255HVXR) SESAME SEED 9 [hp_X] in 1 mL SOYBEAN (UNII: L7HT8F1ZOD) (SOYBEAN - UNII:L7HT8F1ZOD) SOYBEAN 9 [hp_X] in 1 mL SUCROSE (UNII: C151H8M554) (SUCROSE - UNII:C151H8M554) SUCROSE 9 [hp_X] in 1 mL SUNFLOWER SEED (UNII: R9N3379M4Z) (SUNFLOWER SEED - UNII:R9N3379M4Z) SUNFLOWER SEED 9 [hp_X] in 1 mL WHEAT (UNII: 4J2I0SN84Y) (WHEAT - UNII:4J2I0SN84Y) WHEAT 9 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 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 SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [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:43857-0635-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 06/20/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/20/2023 Labeler - BioActive Nutritional, Inc. (624980496) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43857-0635) , api manufacture(43857-0635) , label(43857-0635) , pack(43857-0635)