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:

    For temporary relief of allergies due to grain and seeds.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health care 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 a 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:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of allergies due to grain and seeds.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    GRAIN & SEED ANTIGENS

    HOMEOPATHIC

    1 FL OZ (30 ml)

    GRAIN & SEED ANTIGENS

  • 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 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0635
    Route of AdministrationORALDEA ScheduleCII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMARANTHUS CRUENTUS SEED (UNII: 0C5WAA83X5) (AMARANTHUS CRUENTUS SEED - UNII:0C5WAA83X5) AMARANTHUS CRUENTUS SEED9 [hp_X]  in 1 mL
    BAMBUSA VULGARIS STEM (UNII: SMR633LHTC) (BAMBUSA VULGARIS STEM - UNII:SMR633LHTC) BAMBUSA VULGARIS STEM9 [hp_X]  in 1 mL
    BARLEY (UNII: 5PWM7YLI7R) (BARLEY - UNII:5PWM7YLI7R) BARLEY9 [hp_X]  in 1 mL
    BUCKWHEAT (UNII: N0Y68724R3) (BUCKWHEAT - UNII:N0Y68724R3) BUCKWHEAT9 [hp_X]  in 1 mL
    CORN (UNII: 0N8672707O) (CORN - UNII:0N8672707O) CORN9 [hp_X]  in 1 mL
    FLAX SEED (UNII: 4110YT348C) (FLAX SEED - UNII:4110YT348C) FLAX SEED9 [hp_X]  in 1 mL
    LENTIL (UNII: 6O38V6B52O) (LENTIL - UNII:6O38V6B52O) LENTIL9 [hp_X]  in 1 mL
    MILLET (UNII: TJR6B3R47P) (MILLET - UNII:TJR6B3R47P) MILLET9 [hp_X]  in 1 mL
    SORGHUM BICOLOR WHOLE (UNII: Y3T98X3AL6) (SORGHUM BICOLOR WHOLE - UNII:Y3T98X3AL6) SORGHUM BICOLOR WHOLE9 [hp_X]  in 1 mL
    OAT (UNII: Z6J799EAJK) (OAT - UNII:Z6J799EAJK) OAT9 [hp_X]  in 1 mL
    POPPY SEED (UNII: 60RO23IR87) (POPPY SEED - UNII:60RO23IR87) POPPY SEED9 [hp_X]  in 1 mL
    WHITE RICE (UNII: A195V20H7A) (WHITE RICE - UNII:A195V20H7A) WHITE RICE9 [hp_X]  in 1 mL
    RYE (UNII: 0R4AQI398X) (RYE - UNII:0R4AQI398X) RYE9 [hp_X]  in 1 mL
    SESAME SEED (UNII: 7Y1255HVXR) (SESAME SEED - UNII:7Y1255HVXR) SESAME SEED9 [hp_X]  in 1 mL
    SOYBEAN (UNII: L7HT8F1ZOD) (SOYBEAN - UNII:L7HT8F1ZOD) SOYBEAN9 [hp_X]  in 1 mL
    SUCROSE (UNII: C151H8M554) (SUCROSE - UNII:C151H8M554) SUCROSE9 [hp_X]  in 1 mL
    SUNFLOWER SEED (UNII: R9N3379M4Z) (SUNFLOWER SEED - UNII:R9N3379M4Z) SUNFLOWER SEED9 [hp_X]  in 1 mL
    WHEAT (UNII: 4J2I0SN84Y) (WHEAT - UNII:4J2I0SN84Y) WHEAT9 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [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
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0635-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/20/2023
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0635) , api manufacture(43857-0635) , label(43857-0635) , pack(43857-0635)
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