Label: HOMEOPATHIC BLADDER CONFIDENCE FORMULA- belladonna, canthris, apis mellifica, arnica montana, allium cepa, rhus aromatica, equisetum hyemale 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 June 24, 2011

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  • ACTIVE INGREDIENT

    Ingredient s :
    Deadly nightshade ............................ 6X HPUS
    Spanish fly .............................. 6X HPUS
    Honeybee ....................... 6X HPUS
    Mountain arnica .................... 6X HPUS
    Red onion ........................... 6X HPUS
    Fragrant sumac ................... 6X HPUS
    Horsetail ............. 6X HPUS
    The letters “HPUS” indicate that the components
    in this product are officially monographed in the
    Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    Helps relieve poor
    bladder control.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF
    REACH OF CHILDREN.

  • INDICATIONS & USAGE

    Helps relieve poor
    bladder control.

  • 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
    1-2 tablets, dissolve under tongue or chew 4 times daily until
    symptoms appear to reduce, then once a day to maintain
    control, or as directed by a health professional. If symptoms
    persist for more than 10 days consult a health professional.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Dextrose,
    Magnesium Stearate, Silica.

  • PRINCIPAL DISPLAY PANEL

    NDC# 1057801518

    Homeopathic
    Bladder
    Confidence™

    Helps relieve poor
    bladder control.

    300 mg.
    180 Tablets

    image of 45 count

    image of 90 count

    image of 180 count
  • SPL UNCLASSIFIED SECTION

    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

    FDA Establishment #: 1811575

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

  • INGREDIENTS AND APPEARANCE
    HOMEOPATHIC BLADDER CONFIDENCE FORMULA 
    belladonna, canthris, apis mellifica, arnica montana, allium cepa, rhus aromatica, equisetum hyemale tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10578-015
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [hp_X]
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA6 [hp_X]
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]
    RHUS AROMATICA ROOT BARK (UNII: Q3H36W0J42) (RHUS AROMATICA ROOT BARK - UNII:Q3H36W0J42) RHUS AROMATICA ROOT BARK6 [hp_X]
    EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE6 [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:10578-015-4545 in 1 BOTTLE
    2NDC:10578-015-9090 in 1 BOTTLE
    3NDC:10578-015-18180 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2001
    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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