Tinnitus

Manufacturer
Apotheca Company
Effective date
2011-03-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:03:06

Label at a glance#

ProductTinnitus DX
Active ingredientOYSTER SHELL CALCIUM CARBONATE, CRUDE, ACTIVATED CHARCOAL, QUININE SULFATE, BLACK COHOSH, CINCHONA OFFICINALIS BARK, ARABICA COFFEE BEAN, GRAPHITE, POTASSIUM CARBONATE, LYCOPODIUM CLAVATUM SPORE, SODIUM SALICYLATE, SALICYLIC ACID
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

PURPOSE:  Tinnitus DX combines clinically researched ingredients to support maximum ear health and resolve noise problems in the ear.

WARNINGS SECTION

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 SECTION

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 SECTION

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 SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

PURPOSE:  Tinnitus DX combines clinically researched ingredients to support maximum ear health and resolve noise problems in the ear.

OTC - QUESTIONS SECTION

Questions?

Call 877-212-7282

Dist By:

Vita Sciences

Princeton Sciences

Almont, NY 10952 USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tinnitus DX

Homeopathic Remedy

Relief from:

Ringing or buzzing in ears

Ear noise

Sensitivity to sound

Doctor Recommended

60 Capsules

Tinnitus DXTinnitus DX

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57520-0363-12020-01-31C16284748780-19d75b9d0-877f-f424-e053-dadaa90a57ceTinnitus DX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57520-0363-1TinnitusDX60 in 1 BOTTLECAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57520-0363TINNITUS DX (CALCAREA CARBONICA, CARBO VEGETABILIS, CHININUM SULPHURICUM, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COFFEA CRUDA, GRAPHITES, KALI CARBONICUM,) CAPSULE [APOTHECA COMPANY]2Legacy NDC, 1 package rows20110331_1e6d6cd5-ab14-4258-a0fe-5f6a3cae437f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACTIVATED CHARCOALACTIVE INGREDIENT2P3VWU3H102
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX722
BLACK COHOSHACTIVE INGREDIENTK73E24S6X92
CINCHONA OFFICINALIS BARKACTIVE INGREDIENTS003A158SB2
GRAPHITEACTIVE INGREDIENT4QQN74LH4O2
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4792
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6I2
POTASSIUM CARBONATEACTIVE INGREDIENTBQN1B9B9HA2
QUININE SULFATEACTIVE INGREDIENTKF7Z0E0Q2B2
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ2
SODIUM SALICYLATEACTIVE INGREDIENTWIQ1H85SYP2
ACTIVATED CHARCOALACTIVE MOIETY2P3VWU3H102
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX722
BLACK COHOSHACTIVE MOIETYK73E24S6X92
CINCHONA OFFICINALIS BARKACTIVE MOIETYS003A158SB2
GRAPHITEACTIVE MOIETY4QQN74LH4O2
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4792
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6I2
POTASSIUM CATIONACTIVE MOIETY295O53K1522
QUININEACTIVE MOIETYA7V27PHC7A2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ2
SODIUM CATIONACTIVE MOIETYLYR4M0NH372
ACETYLCYSTEINEINACTIVE INGREDIENTWYQ7N0BPYC2
ALPHA LIPOIC ACIDINACTIVE INGREDIENT73Y7P0K73Y2
AMINOBENZOIC ACIDINACTIVE INGREDIENTTL2TJE8QTX2
BLACK COHOSHINACTIVE INGREDIENTK73E24S6X92
BLACK PEPPERINACTIVE INGREDIENTKM66971LVF2
CHROMIUMINACTIVE INGREDIENT0R0008Q3JB2
COPPER GLUCONATEINACTIVE INGREDIENTRV823G6G672
FOLIC ACIDINACTIVE INGREDIENT935E97BOY82
GARLICINACTIVE INGREDIENTV1V998DC172
GELATININACTIVE INGREDIENT2G86QN327L2
GINGERINACTIVE INGREDIENTC5529G5JPQ2
GINKGOINACTIVE INGREDIENT19FUJ2C58T2
INOSITOL NIACINATEINACTIVE INGREDIENTA99MK953KZ2
IPRIFLAVONEINACTIVE INGREDIENT80BJ7WN25Z2
MAGNESIUM CITRATEINACTIVE INGREDIENTRHO26O1T9V2
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71G2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
MANGANESEINACTIVE INGREDIENT42Z2K6ZL8P2
METHYLCOBALAMININACTIVE INGREDIENTBR1SN1JS2W2
NIACININACTIVE INGREDIENT2679MF687A2
RICEINACTIVE INGREDIENT659G217HPG2
SELENIUMINACTIVE INGREDIENTH6241UJ22B2
THIAMINE MONONITRATEINACTIVE INGREDIENT8K0I04919X2
UBIDECARENONEINACTIVE INGREDIENTEJ27X76M462
VINPOCETINEINACTIVE INGREDIENT543512OBTC2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC2
VITIS VINIFERA SEEDINACTIVE INGREDIENTC34U15ICXA2
ZINC GLUCONATEINACTIVE INGREDIENTU6WSN5SQ1Z2
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54Z2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57520-036357520-0363-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 100 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GTABLET / ORAL63 mgExact identifier — unii candidate
9 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / TRANSMUCOSAL100 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR2 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, EXTENDED RELEASE / ORAL1229 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
GINGERGINGERC5529G5JPQSYRUP / ORAL0.05 ml/5mlExact identifier — unii candidate
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30RING / VAGINAL2 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRAMUSCULAR16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LWAFER / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GTABLET, EXTENDED RELEASE / ORAL25.74 mgExact identifier — unii candidate
9 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL47 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GTABLET, FILM COATED / ORAL80 mgExact identifier — unii candidate
9 equally ranked IID candidates
GELATINGELATIN2G86QN327LSUPPOSITORY / VAGINALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / BUCCAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRAVENOUS20 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, ORALLY DISINTEGRATING / ORAL120 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GCAPSULE, EXTENDED RELEASE / ORAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / SUBCUTANEOUS16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FOR SUSPENSION / ORAL131 mgExact identifier — unii candidate
39 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSOLUTION / RESPIRATORY (INHALATION)3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / ORAL46 mgExact identifier — unii candidate
44 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSUPPOSITORY / RECTAL375 mgExact identifier — unii candidate
6 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER / RESPIRATORY (INHALATION)100 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRACAVITARY0.05 mlExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SYSTEM / INTRAVITREAL0.02 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, ORALLY DISINTEGRATING / SUBLINGUAL13 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GCAPSULE, DELAYED RELEASE / ORAL78 mgExact identifier — unii candidate
9 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, EXTENDED RELEASE / ORAL239 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR14 mgExact identifier — unii candidate
44 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZINJECTION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LSOLUTION / INTRAVENOUS34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CREAM / TOPICALNAExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER / ORAL100 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LELIXIR / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM OXIDEMAGNESIUM OXIDE3A3U0GI71GCAPSULE / ORAL20 mgExact identifier — unii candidate
9 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30WAFER / ORAL66 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZINJECTION, SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
6 equally ranked IID candidates
GELATINGELATIN2G86QN327LSYSTEM / TOPICAL1050 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii candidate
44 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a2b4738b-db33-4f58-80b6-e5fc163f30431e6d6cd5-ab14-4258-a0fe-5f6a3cae437f2011-03-30WarningsExact identifier
spl id: a2b4738b-db33-4f58-80b6-e5fc163f3043
spl set id: 1e6d6cd5-ab14-4258-a0fe-5f6a3cae437f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.