Label: TINNITUS REAL RELIEF- kali bromatum, cinchona officinalis, sulphur, dulcamara, hydrastis canadensis, arnica montana, bryonia causticum tablet, chewable

  • 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 October 25, 2012

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  • ACTIVE INGREDIENTS HPUS

    Kali bromatum (Potassium bromide) 8X
    Cinchona officinalis (Peruvian bark) 8X
    Sulphur (Sublimed sulfur) 8X
    Dulcamara (Bittersweet) 8X
    Hydrastis canadensis (Golden seal) 8X
    Arnica montana (Leopard's bane) 8X
    Bryonia (White bryony) 8X
    Causticum (Hahnmann's causticum) 8X

  • PURPOSE

    ringing in the ears
    buzzing in the ears
    roaring in the ears, pressure
    ear pain and headache
    roaring in the ears
    pain and buzzing in the ears
    noise is insupportable
    ringing, roaring, pulsating
  • REFERENCES

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

    USES

    This homeopathic medicine helps relieve symptoms associated with tinnitus:

    - ringing and buzzing in the ear

    - ear pain and pressure

    - headache
  • WARNINGS


    Stop use and ask a doctor if symptoms worsen or persist for more than 7 days.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • DIRECTIONS

    Chew tablets and let dissolve in mouth.

    Do not use more than directed.

    Do not take with food.

    Repeat 3 times daily and reduce intake with improvement or as directed by a health professional.


    Age Dose
    Adults and children 12 years of age and older2 tablets
    Children 2 to 11 years of age
    		1 tablet

  • OTHER INFORMATION

    Store at room temperature (68 - 77F).

    Do not use if seal is broken or missing.

  • INACTIVE INGREDIENTS

    Lactose, magnesium stearate.


  • CARTON

    image of carton label

  • INGREDIENTS AND APPEARANCE
    TINNITUS  REAL RELIEF
    kali bromatum, cinchona officinalis, sulphur, dulcamara, hydrastis canadensis, arnica montana, bryonia causticum tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-6032
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION8 [hp_X]
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK8 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR8 [hp_X]
    SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP8 [hp_X]
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL8 [hp_X]
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA8 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT8 [hp_X]
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM8 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-6032-090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/25/2012
    Labeler - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(60512-6032)
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