Label: TINNITUS DX- calcarea carbonica, carbo vegetabilis, chininum sulphuricum, cimicifuga racemosa, cinchona officinalis, coffea cruda, graphites, kali carbonicum, capsule

  • Category: HUMAN OTC DRUG LABEL

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 30, 2011

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:   Calcarea carbonica 8X, 30X, Carbo vegetabilis 8X, 12X, 30X, Chininum sulphuricum 12X, 30X, Cimicifuga racemosa 3X, 6X, 12X, 30X, Cinchona officinalis 3X, 6X, 30X, Coffea cruda 3X, 12X, Graphites 8X, 12X, 30X, Kali carbonicum 12X, 30X, Lycopodium clavatum 6X, 12X, 30X, Natrum salicylicum 6X, Salicylicum acidum 6X.

  • PURPOSE

    PURPOSE:  Tinnitus DX combines clinically researched ingredients to support maximum ear health and resolve noise problems in the ear.


  • WARNINGS

    WARNINGS:  Use only as directed.

    If you are presently taking blood thinning agents or any medications or 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.


  • INFORMATION FOR PATIENTS

    OTHER INFORMATION:  Tamper sealed: Sealed for your protection.  Do not use if seal is broken or missing.

    Each capsule contains Magnesium 60mg

    Each capsule contains Niacin 25mg

    Niacin may cause a harmless flush reaction in a small percentage of people.

    In the event of flushing, redness, itching or dizziness, drink 10 oz of water and take an antihistamine.  The sensation should diminish within 10-20 minutes.

    For those sensitive to niacin, reduce dosage to one capsule 2 x per day for 2-3 weeks until tolerance is increased.

    To further prevent flushing, avoid warm/hot beverages and food for 90 minutes before and after dose.

    One may take low dose aspirin 30 minutes prior as additional prevention.



  • DOSAGE & ADMINISTRATION

    DIRECTIONS:  For the first 30-90 days, take 2 capsules twice daily with food and 8 oz water.

    Thereafter, reduce dosage to 1 capsule twice daily.

    For best results use daily for 3-5 months.

    For ongoing exposure to loud noise, take preventative dosage of 1 capsule twice daily.


  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Magnesium stearate, Vitamin A palmitate, Thiamine mononitrate, Vitamin B3, Niacin (from Inositol hexanicotinate), Folic acid, Vitamin B12, Magnesium citrate, Magnesium oxide, Zinc gluconate, Zinc oxide, Selenium, Copper gluconate, Manganese, Chromium, L-arginine HCL, N-acetyl-L-cysteine, Ipriflavone, Ginkgo, Grape (seed), Ginger (root), Alpha lipoic acid, Garlic (bulb), PABA (Para-aminobenzoic acid), Black cohosh, Vinpocetine, Black pepper (fruit), Cownzyme Q10, Gelatin, Rice flour.

  • 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

    PURPOSE:  Tinnitus DX combines clinically researched ingredients to support maximum ear health and resolve noise problems in the ear.


  • QUESTIONS

    Questions?

    Call 877-212-7282

    Dist By:

    Vita Sciences

    Princeton Sciences

    Almont, NY 10952 USA

  • PRINCIPAL DISPLAY PANEL

    Tinnitus DX

    Homeopathic Remedy

    Relief from:

    Ringing or buzzing in ears

    Ear noise

    Sensitivity to sound

    Doctor Recommended

    60 Capsules

    Tinnitus DX

  • INGREDIENTS AND APPEARANCE
    TINNITUS  DX
    calcarea carbonica, carbo vegetabilis, chininum sulphuricum, cimicifuga racemosa, cinchona officinalis, coffea cruda, graphites, kali carbonicum, capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0363
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_X]
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL30 [hp_X]
    QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A) QUININE SULFATE30 [hp_X]
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH30 [hp_X]
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK30 [hp_X]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN12 [hp_X]
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE30 [hp_X]
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CARBONATE30 [hp_X]
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_X]
    SODIUM SALICYLATE (UNII: WIQ1H85SYP) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM SALICYLATE6 [hp_X]
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    THIAMINE MONONITRATE (UNII: 8K0I04919X)  
    NIACIN (UNII: 2679MF687A)  
    INOSITOL NIACINATE (UNII: A99MK953KZ)  
    FOLIC ACID (UNII: 935E97BOY8)  
    METHYLCOBALAMIN (UNII: BR1SN1JS2W)  
    MAGNESIUM CITRATE (UNII: RHO26O1T9V)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    SELENIUM (UNII: H6241UJ22B)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    MANGANESE (UNII: 42Z2K6ZL8P)  
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
    IPRIFLAVONE (UNII: 80BJ7WN25Z)  
    GINKGO (UNII: 19FUJ2C58T)  
    GINGER (UNII: C5529G5JPQ)  
    ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y)  
    GARLIC (UNII: V1V998DC17)  
    AMINOBENZOIC ACID (UNII: TL2TJE8QTX)  
    BLACK COHOSH (UNII: K73E24S6X9)  
    VINPOCETINE (UNII: 543512OBTC)  
    BLACK PEPPER (UNII: KM66971LVF)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    GELATIN (UNII: 2G86QN327L)  
    RICE (UNII: 659G217HPG)  
    CHROMIUM (UNII: 0R0008Q3JB)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    Product Characteristics
    Colorwhite (natural gelatin) Scoreno score
    ShapeCAPSULE (none) Size25mm
    FlavorImprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0363-160 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/12/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture