Label: TYPE 4 NOISE REGULAR- causticum, chininum sulphuricum, cinchona officinalis, pulsatilla, thiosinaminum tablet, orally disintegrating

  • 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 April 2, 2013

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  • ACTIVE INGREDIENTS

    Causticum 3X, Chininum Sulphuricum 3X, Cinchona Officinalis 6X, Pulsatilla 6X, Thiosinaminum 6X

  • INDICATIONS

    For relief of ringining in the ear from Cochlea Damage. 

  • WARNINGS

    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.  Do not use if tamper evident seal is broken or missing.  Store in a cool, dry place. 

  • DIRECTIONS

    Take two tablets twice a day under the tongue.

  • INACTIVE INGREDIENTS

    Lactose, Magnesium Steareate, Microcrystalline Cellulose

  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • INDICATIONS AND USAGE

    For relief of ringining in the ear from Cochlea Damage.

  • QUESTIONS

    Manufactured for:

    T-Gone Remedies

    375 N. Stephanie St., Ste 1411

    Henderson, NV  89014-8909

    Web: www.t-gone.com

    Tel: 800-314-2910

  • PRINCIPAL DISPLAY PANEL

    T-Gone Remedies

    Type 4 Noise Regular

    HOMEOPATHIC

    120 TABLETS

    T Gone Remedies

  • INGREDIENTS AND APPEARANCE
    TYPE 4 NOISE REGULAR 
    causticum, chininum sulphuricum, cinchona officinalis, pulsatilla, thiosinaminum tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50169-0001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM3 [hp_X]  in 1 mg
    QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A) QUININE SULFATE3 [hp_X]  in 1 mg
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK6 [hp_X]  in 1 mg
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_X]  in 1 mg
    ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7) ALLYLTHIOUREA6 [hp_X]  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (convex) Size6mm
    FlavorImprint Code Diamond
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50169-0001-115000 mg in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/02/2013
    Labeler - T Gone Remedies (846965817)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(50169-0001)
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