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

Tinnitus by

Drug Labeling and Warnings

Tinnitus by is a Homeopathic medication manufactured, distributed, or labeled by Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57520-0363
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	30 [hp_X]
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	30 [hp_X]
QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A)	QUININE SULFATE	30 [hp_X]
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	30 [hp_X]
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	30 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	12 [hp_X]
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	30 [hp_X]
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CARBONATE	30 [hp_X]
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_X]
SODIUM SALICYLATE (UNII: WIQ1H85SYP) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM SALICYLATE	6 [hp_X]
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (natural gelatin)	Score	no score
Shape	CAPSULE (none)	Size	25mm
Flavor		Imprint Code	none
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57520-0363-1	60 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/12/2010

Labeler - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture