Label: TINNITUS DX- calcarea carbonica, carbo vegetabilis, chininum sulphuricum, cimicifuga racemosa, cinchona officinalis, coffea cruda, graphites, kali carbonicum, capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 57520-0363-1 - Packager: Apotheca Company
- 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 30, 2011
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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
- WARNINGS
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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
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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.
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- INDICATIONS & USAGE
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TINNITUS DX
calcarea carbonica, carbo vegetabilis, chininum sulphuricum, cimicifuga racemosa, cinchona officinalis, coffea cruda, graphites, kali carbonicum, capsuleProduct 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