Label: AMOEBATOX- triticum aestivum, baptisia tinctoria, capsicum annuum, fragaria vesca, hamamelis virginiana, quassia amara, senna, hydrastis canadensis, podophyllum peltatum, hepar bovine, pancreas suis, spleen (bovine), belladonna, cinchona officinalis, lycopodium clavatum, nitricum acidum, nux vomica, giardia lamblia, entamoeba histolytica liquid

  • NDC Code(s): 43857-0517-1
  • Packager: BioActive Nutritional, 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 August 6, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS:

    Triticum Aestivum MT, Baptisia Tinctoria 3X, Capsicum Annuum 3X, Fragaria Vesca 3X, Hamamelis Virginiana 3X, Quassia Amara 3X, Senna 3X, Hydrastis Canadensis 5X, Podophyllum Peltatum 6X, Hepar Bovine 8X, Pancreas Suis 8X, Spleen (Bovine) 8X, Belladonna 12X, Cinchona Officinalis 12X, Lycopodium Clavatum 12X, Nitricum Acidum 12X, Nux Vomica 12X, Giardia Lamblia 15C, 30C, 100C, Entamoeba Histolytica 18C, 30C, 100C.

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  • INDICATIONS:

    For temporary relief of symptoms of diarrhea, mucousy stools, intestinal bloating.

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  • 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 cool, dry place.

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  • 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.

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  • DIRECTIONS:

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

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  • INDICATIONS:

    For temporary relief of symptoms of diarrhea, mucousy stools, intestinal bloating.

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  • INACTIVE INGREDIENTS:

    Cajuput (Leaf) Essential Oil, Demineralized Water, 25% Ethanol

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  • QUESTIONS:

    Distributed by:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

    bioactivenutritional.com

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  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    AMOEBATOX

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Amoebatox

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  • INGREDIENTS AND APPEARANCE
    AMOEBATOX 
    triticum aestivum, baptisia tinctoria, capsicum annuum, fragaria vesca, hamamelis virginiana, quassia amara, senna, hydrastis canadensis, podophyllum peltatum, hepar bovine, pancreas suis, spleen (bovine), belladonna, cinchona officinalis, lycopodium clavatum, nitricum acidum, nux vomica, giardia lamblia, entamoeba histolytica liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0517
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRITICUM AESTIVUM WHOLE (UNII: 3C3Y389JBU) (TRITICUM AESTIVUM WHOLE - UNII:3C3Y389JBU) TRITICUM AESTIVUM WHOLE 1 [hp_X]  in 1 mL
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 3 [hp_X]  in 1 mL
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 3 [hp_X]  in 1 mL
    ALPINE STRAWBERRY (UNII: CG6IX3GCMU) (ALPINE STRAWBERRY - UNII:CG6IX3GCMU) ALPINE STRAWBERRY 3 [hp_X]  in 1 mL
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 3 [hp_X]  in 1 mL
    QUASSIA AMARA WOOD (UNII: S5249Q85HW) (QUASSIA AMARA WOOD - UNII:S5249Q85HW) QUASSIA AMARA WOOD 3 [hp_X]  in 1 mL
    SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX) SENNA LEAF 3 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 5 [hp_X]  in 1 mL
    PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM 6 [hp_X]  in 1 mL
    BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022) BEEF LIVER 8 [hp_X]  in 1 mL
    SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY) SUS SCROFA PANCREAS 8 [hp_X]  in 1 mL
    BOS TAURUS SPLEEN (UNII: 190Q9MB3U3) (BOS TAURUS SPLEEN - UNII:190Q9MB3U3) BOS TAURUS SPLEEN 8 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 12 [hp_X]  in 1 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 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
    NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID 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
    ENTAMOEBA HISTOLYTICA (UNII: 2XC2HJ478W) (ENTAMOEBA HISTOLYTICA - UNII:2XC2HJ478W) ENTAMOEBA HISTOLYTICA 15 [hp_C]  in 1 mL
    GIARDIA LAMBLIA (UNII: 89IEJ09R73) (GIARDIA LAMBLIA - UNII:89IEJ09R73) GIARDIA LAMBLIA 18 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43857-0517-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 08/06/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 08/06/2019
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(43857-0517) , api manufacture(43857-0517) , label(43857-0517) , pack(43857-0517)
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