Label: BIOTOX GUT- cochlearia armoracia, phytolacca decandra, chelidonium majus, intestinal mucosa, spleen, hepar bovine, thymus, salmonella enteritidis, helicobacter pylori, nux vomica, salmonella paratyphi, botulinum liquid

  • NDC Code(s): 50181-0035-1
  • Packager: The Wellness Center for Research and Education, 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 June 18, 2015

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

  • ACTIVE INGREDIENTS:

    Cochlearia Armoracia 3X, Phytolacca Decandra 3X, 6X, Chelidonium Majus 3X, 6X, 8X, Intestinal Mucosa (Bovine) 8X, Spleen (Suis) 8X, Hepar Bovine 8X, 30C, Thymus (Suis) 8X, 1LM, Salmonella Enteritidis 12X, 15X 30X, 30C, 60C, Helicobacter Pylori 15X, 30X, 30C, 60C, Nux Vomica 3C, Salmonella Paratyphi 15C, 30C, 60C, Botulinum 30C.

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  • INDICATIONS:

    Skin rash, headache, mental and physical fatigue, fever, cough, vomiting, flu-like symptoms, heart palpitations, virus, pain, belching, diarrhea, food poisoning, stiffness of limbs.

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  • WARNINGS:

    ​If pregnant or breast-feeding​ ask a health 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.

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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:

    5 drops 2 or 3 times per day, on an empty stomach, 5 days per week or until symptoms abate. Consult a physician for use in children under 12 years of age.

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  • INDICATIONS:

    Skin rash, headache, mental and physical fatigue, fever, cough, vomiting, flu-like symptoms, heart palpitations, virus, pain, belching, diarrhea, food poisoning, stiffness of limbs.

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  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

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  • QUESTIONS:

    MFD FOR:

    The Wellness Center for Research and Education, Inc.

    1237 S. Victoria Ave. Suite 169

    Oxnard, CA 93035

    1-866-962-6484

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  • PACKAGE LABEL DISPLAY:

    Dr. Theresa Dale's

    NDC: 50181-0035-1

    ​Homeopathic

    ​BioTox Gut

    ​1 FL OZ (30 ml)

    BioTox Gut

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  • INGREDIENTS AND APPEARANCE
    BIOTOX GUT 
    cochlearia armoracia, phytolacca decandra, chelidonium majus, intestinal mucosa, spleen, hepar bovine, thymus, salmonella enteritidis, helicobacter pylori, nux vomica, salmonella paratyphi, botulinum liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50181-0035
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HORSERADISH (UNII: 8DS6G120HJ) (HORSERADISH - UNII:8DS6G120HJ) HORSERADISH 3 [hp_X]  in 1 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 3 [hp_X]  in 1 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 3 [hp_X]  in 1 mL
    BOS TAURUS INTESTINAL MUCOSA (UNII: 0989HO597G) (BOS TAURUS INTESTINAL MUCOSA - UNII:0989HO597G) BOS TAURUS INTESTINAL MUCOSA 8 [hp_X]  in 1 mL
    SUS SCROFA SPLEEN (UNII: 92AMN5J79Y) (SUS SCROFA SPLEEN - UNII:92AMN5J79Y) SUS SCROFA SPLEEN 8 [hp_X]  in 1 mL
    BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022) BEEF LIVER 8 [hp_X]  in 1 mL
    SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62) SUS SCROFA THYMUS 8 [hp_X]  in 1 mL
    SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS (UNII: Y3V16D4PV4) (SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS - UNII:Y3V16D4PV4) SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 12 [hp_X]  in 1 mL
    HELICOBACTER PYLORI (UNII: U09W5JOL3Z) (HELICOBACTER PYLORI - UNII:U09W5JOL3Z) HELICOBACTER PYLORI 15 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 3 [hp_C]  in 1 mL
    SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI (UNII: 760T5R8B3O) (SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI - UNII:760T5R8B3O) SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI 15 [hp_C]  in 1 mL
    BOTULINUM TOXIN TYPE A (UNII: E211KPY694) (ABOBOTULINUMTOXINA - UNII:E211KPY694) BOTULINUM TOXIN TYPE A 30 [hp_C]  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:50181-0035-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 01/03/2014
    Labeler - The Wellness Center for Research and Education, Inc. (832363993)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(50181-0035) , api manufacture(50181-0035) , label(50181-0035) , pack(50181-0035)
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