Label: HOMEOPATHIC BRONCHITIS FORMULA- asclepias tuberose, drosera rotundifolia, hepar sulphuris calcareum, silicea, stannum metallicum tablet

  • 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 March 25, 2011

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  • ACTIVE INGREDIENT

    I n g r e d i e n t s :

    Butterfly weed..................... 30X HPUS
    Sundew..................... 30X HPUS
    Calcium sulfide.......... 30X HPUS
    Silica....................................... 30X HPUS
    Tin................... 30X HPUS


    The letters “HPUS” indicate that the components in
    this product are officially monographed in the
    Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    For relief of severe coughs due to cold or flu

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF
    REACH OF CHILDREN.

  • INDICATIONS & USAGE

    For relief of severe coughs due to cold or flu
  • WARNINGS

    Warning: If you are taking any medications or
    are pregnant or breast feeding do not use prior to
    consulting a physician.

  • DOSAGE & ADMINISTRATION


    Suggested Use: Adults and children over 12
    years, take 2 tablets at onset of symptoms, repeat as necessary
    for relief. Dissolve under tongue or
    chew no more than 4 times daily, or as directed by a health care
    professional. Take 15 minutes before or after meals.
    If symptoms persist for more than 3 days or worsen consult a
    health professional.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Dextrose, Magnesium
    Stearate, Silica.

  • PRINCIPAL DISPLAY PANEL

    NDC# 1057803690

    Homeopathic Bronchitis Formula

    For relief of severe coughs due to cold or flu

    300 mg.
    90 Tablets



    image of label






  • USER SAFETY WARNINGS

    For your protection, this container has an outer
    safety seal. (Do not accept if missing or broken.)
    Best if used by date on bottle. Store in a dry cool place.
    Any Questions? 1-800-644-8327
    website: www.botanicchoice.com

  • SPL UNCLASSIFIED SECTION

    FDA Establishment #: 1811575

    Distributed by: Indiana Botanic Gardens, Inc.
    3401 W. 37th Ave. Hobart, IN 46342

  • INGREDIENTS AND APPEARANCE
    HOMEOPATHIC BRONCHITIS FORMULA 
    asclepias tuberose, drosera rotundifolia, hepar sulphuris calcareum, silicea, stannum metallicum tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10578-036
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCLEPIAS TUBEROSA FLOWERING TOP (UNII: Y62M9GTW4A) (ASCLEPIAS TUBEROSA FLOWERING TOP - UNII:Y62M9GTW4A) ASCLEPIAS TUBEROSA FLOWERING TOP30 [hp_X]
    DROSERA ROTUNDIFOLIA (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA - UNII:75O014T1HG) DROSERA ROTUNDIFOLIA30 [hp_X]
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFIDE30 [hp_X]
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]
    TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN30 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code H;367
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10578-036-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/30/2010
    Labeler - Indiana Botanic Gardens (005421771)
    Registrant - Indiana Botanic Gardens (005421771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Indiana Botanic Gardens005421771label
    Establishment
    NameAddressID/FEIBusiness Operations
    ASI Marketing Group964366611manufacture
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