Label: TINNITUS RELIEF- arnica montana, calcarea carbonica, chenopodium anthelminticum, chininum salicylicum, cimicifuga racemosa, coffea tosta, kali iodatum, kalmia latifolia, magnesia carbonica, manganum aceticum, manganum carbonicum, mercurius vivus, natrum salicylicum, salicylicum acidum, thiosinaminum, thyroidinum liquid

  • 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 March 4, 2015

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

View All Sections
  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: ​Arnica montana, Calcarea carbonica, Chenopodium anthelminticum, Chininum salicylicum, Cimicifuga racemosa, Coffea tosta, Kali iodatum, Kalmia latifolia, Magnesia carbonica, Manganum acxeticum, Manganum carbonicum, Mercurius vivus, Natrum salicylicum, Salicylicum acidum, Thiosinaminum, Thyroidinum. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

  • INDICATIONS & USAGE

    Uses for temporary relief of symptoms: intermittent, continuous or pulsating ear sounds (buzzing, hissing, and whistling), acute sensitivity to sounds, hearing loss.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

  • WARNINGS

    Warnings

    • Stop use and ask your doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, take only on advice of a healthcare professional.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • Adults 12 and up: 3 sprays 3 times per day
    • Children 2-12: 2 sprays 3 times per day
    • Children 2mo-2yr.: 1 spray 3 times per day
  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

  • PURPOSE

    Uses ​for temporary relief of symptoms:

    • intermittent, continuous or pulsating ear sounds (buzzing, hissing, and whistling)
    • acute sensitivity to sounds
    • hearing loss.
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    TINNITUS RELIEF 
    arnica montana, calcarea carbonica, chenopodium anthelminticum, chininum salicylicum, cimicifuga racemosa, coffea tosta, kali iodatum, kalmia latifolia, magnesia carbonica, manganum aceticum, manganum carbonicum, mercurius vivus, natrum salicylicum, salicylicum acidum, thiosinaminum, thyroidinum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0275
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA10 [hp_X]  in 59 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]  in 59 mL
    DYSPHANIA AMBROSIOIDES (UNII: 4H5RSU087I) (CHENOPODIUM AMBROSIOIDES - UNII:4H5RSU087I) DYSPHANIA AMBROSIOIDES10 [hp_X]  in 59 mL
    QUININE SALICYLATE (UNII: 6DY04L71DR) (SALICYLIC ACID - UNII:O414PZ4LPZ) QUININE SALICYLATE10 [hp_X]  in 59 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH10 [hp_X]  in 59 mL
    COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E) COFFEA ARABICA SEED, ROASTED10 [hp_X]  in 59 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION10 [hp_X]  in 59 mL
    KALMIA LATIFOLIA LEAF (UNII: 79N6542N18) (KALMIA LATIFOLIA LEAF - UNII:79N6542N18) KALMIA LATIFOLIA LEAF10 [hp_X]  in 59 mL
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE10 [hp_X]  in 59 mL
    MANGANESE ACETATE TETRAHYDRATE (UNII: 9TO51D176N) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE ACETATE TETRAHYDRATE10 [hp_X]  in 59 mL
    MANGANESE CARBONATE (UNII: 9ZV57512ZM) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE CATION (2+)10 [hp_X]  in 59 mL
    MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY10 [hp_X]  in 59 mL
    SODIUM SALICYLATE (UNII: WIQ1H85SYP) (SALICYLIC ACID - UNII:O414PZ4LPZ) SODIUM SALICYLATE10 [hp_X]  in 59 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 [hp_X]  in 59 mL
    ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7) ALLYLTHIOUREA10 [hp_X]  in 59 mL
    THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0275-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/06/2012
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0275)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!