Label: TYPE 3 SINUS MAX- calcarea carbonica, hydrastis candensis, kali bichromicum, silicea tablet, orally disintegrating

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated September 5, 2013

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS:

    Calcare Carbonica 200C, Hydrastis Canadensis 200C, Kali Bichromicum 200C, Silicea 200C.

  • INDICATIONS:

    For relief of ringing in the ear from Sinus/Allergies.

  • 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.

  • 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.

  • DIRECTIONS:

    Take two tablets twice a day under the tongue.

  • INDICATIONS:

    For relief of ringing in the ear from Sinus/Allergies.

  • INACTIVE INGREDIENTS:

    Lactose, Manesium Stearate, Microcrystalline Cellulose.

  • QUESTIONS:

    ​Manufactured for:

    T-Gone Remedies

    375 N. Stephanie St., Ste 1411

    Henderson, NV 89014-8909

    Web: ww.t-gone.com

    Tel: 800-314-2910

    customercare@t-gone.com

  • PACKAGE DISPLAY LABEL:

    T-Gone Remedies.

    Type 3 Sinus Max

    HOMEOPATHIC

    120 TABLETS

    image description

  • INGREDIENTS AND APPEARANCE
    TYPE 3 SINUS MAX 
    calcarea carbonica, hydrastis candensis, kali bichromicum, silicea tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50169-0005
    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, CRUDE200 [hp_C]
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL200 [hp_C]
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE200 [hp_C]
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE200 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code Diamond
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50169-0005-1120 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/05/2013
    Labeler - TGone Remedies Ltd (846965817)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(50169-0005) , api manufacture(50169-0005) , label(50169-0005) , pack(50169-0005)