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

  • Category: HUMAN OTC DRUG LABEL

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

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  • 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.

  • 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.

  • 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.

  • 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:

    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.

  • 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.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    MFD FOR:

    The Wellness Center for Research and Education, Inc.

    1237 S. Victoria Ave. Suite 169

    Oxnard, CA 93035

    1-866-962-6484

  • PACKAGE LABEL DISPLAY:

    Dr. Theresa Dale's

    NDC: 50181-0035-1

    ​Homeopathic

    ​BioTox Gut

    ​1 FL OZ (30 ml)

    BioTox Gut

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:50181-0035
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HORSERADISH (UNII: 8DS6G120HJ) (HORSERADISH - UNII:8DS6G120HJ) HORSERADISH3 [hp_X]  in 1 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [hp_X]  in 1 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS3 [hp_X]  in 1 mL
    BOS TAURUS INTESTINAL MUCOSA (UNII: 0989HO597G) (BOS TAURUS INTESTINAL MUCOSA - UNII:0989HO597G) BOS TAURUS INTESTINAL MUCOSA8 [hp_X]  in 1 mL
    SUS SCROFA SPLEEN (UNII: 92AMN5J79Y) (SUS SCROFA SPLEEN - UNII:92AMN5J79Y) SUS SCROFA SPLEEN8 [hp_X]  in 1 mL
    BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022) BEEF LIVER8 [hp_X]  in 1 mL
    SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62) SUS SCROFA THYMUS8 [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 ENTERITIDIS12 [hp_X]  in 1 mL
    HELICOBACTER PYLORI (UNII: U09W5JOL3Z) (HELICOBACTER PYLORI - UNII:U09W5JOL3Z) HELICOBACTER PYLORI15 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED3 [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 TYPHI15 [hp_C]  in 1 mL
    BOTULINUM TOXIN TYPE A (UNII: E211KPY694) (ABOBOTULINUMTOXINA - UNII:E211KPY694) BOTULINUM TOXIN TYPE A30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50181-0035-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/03/2014
    Labeler - The Wellness Center for Research and Education, Inc. (832363993)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(50181-0035) , api manufacture(50181-0035) , label(50181-0035) , pack(50181-0035)
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