Label: TINNITUS RELIEF- kalium bromatum, nux vomica, china rubra, sulphur, sanguinaria canadensis, dulcamara, hydrastis canadensis, arnica montana, bryonia alba, causticum pellet

  • 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 5, 2013

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  • ACTIVE INGREDIENTS HPUS

    Kalium bromatum 3X

    Nux vomica 4X

    China rubra 4X

    Sulphur 4X

    Sanguinaria canadensis 4X

    Dulcamara 3X

    Hydrastis canadensis 3X

    Arnica montana 4X

    Bryonia alba 4X

    Causticum 6X

  • REFERENCES

    Manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS)

  • PURPOSE

    Helps relieve ringing and buzzing in the ears

  • USES

    This Homeopathic product of natural source provides symptomatic relief from ringing and buzzing in the ears.

  • WARNINGS

  • ASK DOCTOR

    If symptoms persist or worsen, discontinue use and contact a health professional.

  • PREGNANCY OR BREAST FEEDING

    As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medications out of reach of children.

  • DIRECTIONS

    Adults: Allow 3 pellets to dissolve under the tongue 3 times a day or as directed by a health professional.

    For adult use only. Do not exceed recommended dosage.

  • OTHER INFORMATION

    Do not use if cap seal is broken.

    Homeolab USA Inc., 3025 De L'Assomption Blvd., Montreal, QC H1N 2H2  Canada

    PRODUCT OF CANADA

  • CARTON

    IMAGE OF CARTONIMAGE OF LABEL

  • INGREDIENTS AND APPEARANCE
    TINNITUS RELIEF 
    kalium bromatum, nux vomica, china rubra, sulphur, sanguinaria canadensis, dulcamara, hydrastis canadensis, arnica montana, bryonia alba, causticum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9054
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE3 [hp_X]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED4 [hp_X]
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK4 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR4 [hp_X]
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT4 [hp_X]
    SOLANUM DULCAMARA STEM (UNII: IR986LE7DF) (SOLANUM DULCAMARA STEM - UNII:IR986LE7DF) SOLANUM DULCAMARA STEM3 [hp_X]
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL3 [hp_X]
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA4 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT4 [hp_X]
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-9054-180 in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/18/2013
    Labeler - HOMEOLAB USA INC. (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC.202032533manufacture(60512-9054)
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