Label: BOWEL NOSODE B FAECALIS 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 January 18, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Sepia 3X, 6X, B. Faecalis 30C.

  • PURPOSE

    INDICATIONS:  Action on nearly every tissue-organ, female hormonal complaints, very weak hemorrhage, paralytic affections of pelvic and abdominal viscera, general circulation.

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:  On an empty stomach.  Only give one Bowel Nosode at a time.  5 drops 1 to 2 times daily five days per week for 4 to 6 weeks.  Consult a physician for use in children under 12 years of age.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Demineralized water, 25% Alcohol

  • 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.

  • INDICATIONS & USAGE

    INDICATIONS:  Action on nearly every tissue-organ, female hormonal complaints, very weak hemorrhage, paralytic affections of pelvic and abdominal viscera, general circulation.

  • QUESTIONS

    MFG. FOR:

    Theresa Dale N.D.

    1237 S Victoria Ave.

    Oxnard, CA 93035

    1-866-962-6484


  • PRINCIPAL DISPLAY PANEL

    Dr. Theresa Dale's

    NDC 57520-0323-1

    HOMEOPATHIC

    Bowel Nosode B. Faecalis

    1 fl oz (30 ml)

    Bowel Nosode B. Faecalis

  • INGREDIENTS AND APPEARANCE
    BOWEL NOSODE B FAECALIS 
    bowel nosode b faecalis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0323
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE3 [hp_X]  in 1 mL
    ALCALIGENES FAECALIS (UNII: 05KB30NGW2) (ALCALIGENES FAECALIS - UNII:05KB30NGW2) ALCALIGENES FAECALIS30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0323-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/12/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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