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

Tinnitus Relief by

Drug Labeling and Warnings

Tinnitus Relief by is a Homeopathic medication manufactured, distributed, or labeled by King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57955-0275
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	10 [hp_X]  in 59 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	10 [hp_X]  in 59 mL
DYSPHANIA AMBROSIOIDES (UNII: 4H5RSU087I) (CHENOPODIUM AMBROSIOIDES - UNII:4H5RSU087I)	DYSPHANIA AMBROSIOIDES	10 [hp_X]  in 59 mL
QUININE SALICYLATE (UNII: 6DY04L71DR) (SALICYLIC ACID - UNII:O414PZ4LPZ)	QUININE SALICYLATE	10 [hp_X]  in 59 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	10 [hp_X]  in 59 mL
COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E)	COFFEA ARABICA SEED, ROASTED	10 [hp_X]  in 59 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	10 [hp_X]  in 59 mL
KALMIA LATIFOLIA LEAF (UNII: 79N6542N18) (KALMIA LATIFOLIA LEAF - UNII:79N6542N18)	KALMIA LATIFOLIA LEAF	10 [hp_X]  in 59 mL
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	10 [hp_X]  in 59 mL
MANGANESE ACETATE TETRAHYDRATE (UNII: 9TO51D176N) (MANGANESE CATION (2+) - UNII:H6EP7W5457)	MANGANESE ACETATE TETRAHYDRATE	10 [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)	MERCURY	10 [hp_X]  in 59 mL
SODIUM SALICYLATE (UNII: WIQ1H85SYP) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SODIUM SALICYLATE	10 [hp_X]  in 59 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 [hp_X]  in 59 mL
ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7)	ALLYLTHIOUREA	10 [hp_X]  in 59 mL
THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P)	THYROID, UNSPECIFIED	10 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57955-0275-2	59 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/06/2012

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(57955-0275)