Label: BIOTOX P- pertussinum liquid

  • NDC Code(s): 50181-0057-1
  • Packager: The Wellness Center For Research and Education
  • 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 February 27, 2018

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  • ACTIVE INGREDIENT:

    Pertussinum 15C, 30C, 60C, 200C.

  • INDICATIONS:

    Whooping cough, pertussis, and other spasmodic coughs and homeoprophylaxis.

  • WARNINGS:

    If you are pregnant or breastfeeding, ask a health professional before using this product.

    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.

  • 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 tongue), 5 days per week until symptoms improve, then 5 drops 3 times daily for 3 days per week until symptoms abate. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    Whooping cough, pertussis, and other spasmodic coughs and homeoprophylaxis.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    MFD FOR:

    The Wellness Center for Research

    and Education, Inc.,

    1237 S. Victoria, Suite 169

    Oxnard, CA 93035  1-866-962-6484

  • PACKAGE LABEL DISPLAY:

    Dr. Theresa Dale's

    NDC 50181-0057-1

    Homeopathic

    BioTox

    P

    1 fl oz (30 ml)

    BioTox P

  • INGREDIENTS AND APPEARANCE
    BIOTOX P 
    pertussinum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50181-0057
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED (UNII: U364V64HUN) (HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED - UNII:U364V64HUN) HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED15 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50181-0057-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/27/2018
    Labeler - The Wellness Center For Research and Education (832363993)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(50181-0057) , api manufacture(50181-0057) , label(50181-0057) , pack(50181-0057)
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