Label: AMOEBATOX (triticum aestivum, baptisia tinctoria, capsicum annuum, frasera caroliniensis, hamamelis virginiana, hydrastis canadensis, quassia amara, senna, hydrastis canadensis, hepar bovine, pancreas suis, spleen- bovine, belladonna, cinchona officinalis, lycopodium clavatum, nitricum acidum, nux vomica, entamoeba histolytica, giardia lamblia30 liquid

  • NDC Code(s): 43857-0409-1
  • 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 18, 2016

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, Frasera Caroliniensis 3X, Hamamelis Virginiana 3X, Quassia Amara 3X, Senna 3X, Hydrastis Canadensis 5X, Hepar Bovine 8X, Pancreas Suis 8X, Spleen (Bovine) 8X, Belladonna 12X, Cinchona Officinalis 12X, Lycopodium Clavatum 12X, Nitricum Acidum 12X, Nux Vomica 12X, Entamoeba Histolytica 15C, 30C, 100C, Giardia Lamblia 15C, 30C, 100C.

  • INDICATIONS:

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

  • 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.

  • 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.

  • 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 symptoms of diarrhea, mucousy stools, intestinal bloating.

  • INACTIVE INGREDIENTS:

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

  • QUESTIONS:

    Distributed by:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    AMOEBATOX

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Amoebatox

  • INGREDIENTS AND APPEARANCE
    AMOEBATOX 
    triticum aestivum, baptisia tinctoria, capsicum annuum, frasera caroliniensis, hamamelis virginiana, hydrastis canadensis, quassia amara, senna, hydrastis canadensis, hepar bovine, pancreas suis, spleen (bovine), belladonna, cinchona officinalis, lycopodium clavatum, nitricum acidum, nux vomica, entamoeba histolytica, giardia lamblia30 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0409
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRITICUM AESTIVUM WHOLE (UNII: 3C3Y389JBU) (TRITICUM AESTIVUM WHOLE - UNII:3C3Y389JBU) TRITICUM AESTIVUM WHOLE1 [hp_X]  in 1 mL
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT3 [hp_X]  in 1 mL
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM3 [hp_X]  in 1 mL
    ALPINE STRAWBERRY (UNII: CG6IX3GCMU) (ALPINE STRAWBERRY - UNII:CG6IX3GCMU) ALPINE STRAWBERRY3 [hp_X]  in 1 mL
    FRASERA CAROLINIENSIS ROOT (UNII: 1JX35YMF5T) (FRASERA CAROLINIENSIS ROOT - UNII:1JX35YMF5T) FRASERA CAROLINIENSIS ROOT3 [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 BARK3 [hp_X]  in 1 mL
    QUASSIA AMARA WOOD (UNII: S5249Q85HW) (QUASSIA AMARA WOOD - UNII:S5249Q85HW) QUASSIA AMARA WOOD3 [hp_X]  in 1 mL
    SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX) SENNA LEAF3 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL5 [hp_X]  in 1 mL
    BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022) BEEF LIVER8 [hp_X]  in 1 mL
    SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY) SUS SCROFA PANCREAS8 [hp_X]  in 1 mL
    BOS TAURUS SPLEEN (UNII: 190Q9MB3U3) (BOS TAURUS SPLEEN - UNII:190Q9MB3U3) BOS TAURUS SPLEEN8 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]  in 1 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK12 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
    NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID12 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 1 mL
    ENTAMOEBA HISTOLYTICA (UNII: 2XC2HJ478W) (ENTAMOEBA HISTOLYTICA - UNII:2XC2HJ478W) ENTAMOEBA HISTOLYTICA15 [hp_C]  in 1 mL
    GIARDIA LAMBLIA (UNII: 89IEJ09R73) (GIARDIA LAMBLIA - UNII:89IEJ09R73) GIARDIA LAMBLIA15 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0409-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/18/2016
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0409) , api manufacture(43857-0409) , label(43857-0409) , pack(43857-0409)