Label: BIOTOX BAC 3 (mycoplasma pneumoniae, proteus (vulgaris), candida albicans, colibacillinum cum natrum muriaticum, mycobacterium paratuberculosis, pasteurellosis- pasteurella multocida, pneumococcinum, thuja occidentalis, mycobacterium avium paratuberculosis, phytolacca decandra, legionella pneumophila, shigella sonnei liquid

  • 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 November 8, 2021

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  • ACTIVE INGREDIENTS:

    Mycoplasma Pneumoniae 9X, 30X, 60X, Proteus (Vulgaris) 12X, 30X, 60X, Candida Albicans 15X, 30X, 60X, Colibacillinum Cum Natrum Muriaticum 15X, 30X, 60X, Mycobacterium Paratuberculosis 15X, 30X, 60X, Pasteurellosis (Pasteurella Multocida) 15X, 30X, 60X, Pneumococcinum 15X, 30X, 60X, Thuja Occidentalis 15X, 30X, 60X, Mycobacterium Avium Paratuberculosis 28X, 30X, 60X, Phytolacca Decandra 6C, 12C, 30C, 60C, Legionella Pneumophila 15C, 30C, 60C, Shigella Sonnei 15C, 30C, 60C.

  • INDICATIONS:

    For temporary relief of fever and chills. Promotes a productive wet cough and the coughing up of phlegm. expectorant. Helps relieve the presence of mucus in the stool and loose stools. 

  • 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 three times daily (under tongus), 5 days per week (between meals, food and beverage), unless otherwise directed by health provider.

    Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of fever and chills. Promotes a productive wet cough and the coughing up of phlegm. expectorant. Helps relieve the presence of mucus in the stool and loose stools.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Organic Ethanol

  • QUESTONS:

    MFD FOR: The Wellness Center for

    Research and Education, Inc.

    1237 S. Victoria Ave. Suite 169

    Oxnard, CA 93035

  • PACKAGE LABEL DISPLAY:

    Dr. Theresa Dale's

    NDC 50181-0078-1

    Homeopathic

    BioTox Bac 3

    1 fl oz (30 ml)

    BioTox Bac 3

  • INGREDIENTS AND APPEARANCE
    BIOTOX BAC  3
    mycoplasma pneumoniae, proteus (vulgaris), candida albicans, colibacillinum cum natrum muriaticum, mycobacterium paratuberculosis, pasteurellosis (pasteurella multocida), pneumococcinum, thuja occidentalis, mycobacterium avium paratuberculosis, phytolacca decandra, legionella pneumophila, shigella sonnei liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50181-0078
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MYCOPLASMA PNEUMONIAE (UNII: JQE470FAD0) (MYCOPLASMA PNEUMONIAE - UNII:JQE470FAD0) MYCOPLASMA PNEUMONIAE9 [hp_X]  in 1 mL
    PROTEUS INCONSTANS (UNII: UTX536WN6N) (PROTEUS INCONSTANS - UNII:UTX536WN6N) PROTEUS INCONSTANS12 [hp_X]  in 1 mL
    CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS15 [hp_X]  in 1 mL
    ESCHERICHIA COLI (UNII: 514B9K0L10) (ESCHERICHIA COLI - UNII:514B9K0L10) ESCHERICHIA COLI15 [hp_X]  in 1 mL
    MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS (UNII: XH0F4IP2RX) (MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS - UNII:XH0F4IP2RX) MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS15 [hp_X]  in 1 mL
    PASTEURELLA MULTOCIDA (UNII: IX56B2GQX6) (PASTEURELLA MULTOCIDA - UNII:IX56B2GQX6) PASTEURELLA MULTOCIDA15 [hp_X]  in 1 mL
    STREPTOCOCCUS PNEUMONIAE (UNII: BT6U234YR2) (STREPTOCOCCUS PNEUMONIAE - UNII:BT6U234YR2) STREPTOCOCCUS PNEUMONIAE15 [hp_X]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG15 [hp_X]  in 1 mL
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT6 [hp_C]  in 1 mL
    LEGIONELLA PNEUMOPHILA (UNII: TJR6ZFY0F0) (LEGIONELLA PNEUMOPHILA - UNII:TJR6ZFY0F0) LEGIONELLA PNEUMOPHILA15 [hp_C]  in 1 mL
    SHIGELLA SONNEI (UNII: OO358E3009) (SHIGELLA SONNEI - UNII:OO358E3009) SHIGELLA SONNEI15 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50181-0078-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/08/2021
    Labeler - The Wellness Center for Research and Education, Inc. (832363993)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(50181-0078) , api manufacture(50181-0078) , label(50181-0078) , pack(50181-0078)
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