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#
Contacts and useful links#
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
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57520-0363-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-877f-f424-e053-dadaa90a57ce | Tinnitus DX |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57520-0363-1 | TinnitusDX | 60 in 1 BOTTLE | CAPSULE | 60 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 57520-0363 | TINNITUS DX (CALCAREA CARBONICA, CARBO VEGETABILIS, CHININUM SULPHURICUM, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COFFEA CRUDA, GRAPHITES, KALI CARBONICUM,) CAPSULE [APOTHECA COMPANY] | 2 | Legacy NDC, 1 package rows | 20110331_1e6d6cd5-ab14-4258-a0fe-5f6a3cae437f.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACTIVATED CHARCOAL | ACTIVE INGREDIENT | 2P3VWU3H10 | 2 | |
| ARABICA COFFEE BEAN | ACTIVE INGREDIENT | 3SW678MX72 | 2 | |
| BLACK COHOSH | ACTIVE INGREDIENT | K73E24S6X9 | 2 | |
| CINCHONA OFFICINALIS BARK | ACTIVE INGREDIENT | S003A158SB | 2 | |
| GRAPHITE | ACTIVE INGREDIENT | 4QQN74LH4O | 2 | |
| LYCOPODIUM CLAVATUM SPORE | ACTIVE INGREDIENT | C88X29Y479 | 2 | |
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | ACTIVE INGREDIENT | 2E32821G6I | 2 | |
| POTASSIUM CARBONATE | ACTIVE INGREDIENT | BQN1B9B9HA | 2 | |
| QUININE SULFATE | ACTIVE INGREDIENT | KF7Z0E0Q2B | 2 | |
| SALICYLIC ACID | ACTIVE INGREDIENT | O414PZ4LPZ | 2 | |
| SODIUM SALICYLATE | ACTIVE INGREDIENT | WIQ1H85SYP | 2 | |
| ACTIVATED CHARCOAL | ACTIVE MOIETY | 2P3VWU3H10 | 2 | |
| ARABICA COFFEE BEAN | ACTIVE MOIETY | 3SW678MX72 | 2 | |
| BLACK COHOSH | ACTIVE MOIETY | K73E24S6X9 | 2 | |
| CINCHONA OFFICINALIS BARK | ACTIVE MOIETY | S003A158SB | 2 | |
| GRAPHITE | ACTIVE MOIETY | 4QQN74LH4O | 2 | |
| LYCOPODIUM CLAVATUM SPORE | ACTIVE MOIETY | C88X29Y479 | 2 | |
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | ACTIVE MOIETY | 2E32821G6I | 2 | |
| POTASSIUM CATION | ACTIVE MOIETY | 295O53K152 | 2 | |
| QUININE | ACTIVE MOIETY | A7V27PHC7A | 2 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | 2 | |
| SODIUM CATION | ACTIVE MOIETY | LYR4M0NH37 | 2 | |
| ACETYLCYSTEINE | INACTIVE INGREDIENT | WYQ7N0BPYC | 2 | |
| ALPHA LIPOIC ACID | INACTIVE INGREDIENT | 73Y7P0K73Y | 2 | |
| AMINOBENZOIC ACID | INACTIVE INGREDIENT | TL2TJE8QTX | 2 | |
| BLACK COHOSH | INACTIVE INGREDIENT | K73E24S6X9 | 2 | |
| BLACK PEPPER | INACTIVE INGREDIENT | KM66971LVF | 2 | |
| CHROMIUM | INACTIVE INGREDIENT | 0R0008Q3JB | 2 | |
| COPPER GLUCONATE | INACTIVE INGREDIENT | RV823G6G67 | 2 | |
| FOLIC ACID | INACTIVE INGREDIENT | 935E97BOY8 | 2 | |
| GARLIC | INACTIVE INGREDIENT | V1V998DC17 | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 2 | |
| GINGER | INACTIVE INGREDIENT | C5529G5JPQ | 2 | |
| GINKGO | INACTIVE INGREDIENT | 19FUJ2C58T | 2 | |
| INOSITOL NIACINATE | INACTIVE INGREDIENT | A99MK953KZ | 2 | |
| IPRIFLAVONE | INACTIVE INGREDIENT | 80BJ7WN25Z | 2 | |
| MAGNESIUM CITRATE | INACTIVE INGREDIENT | RHO26O1T9V | 2 | |
| MAGNESIUM OXIDE | INACTIVE INGREDIENT | 3A3U0GI71G | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 2 | |
| MANGANESE | INACTIVE INGREDIENT | 42Z2K6ZL8P | 2 | |
| METHYLCOBALAMIN | INACTIVE INGREDIENT | BR1SN1JS2W | 2 | |
| NIACIN | INACTIVE INGREDIENT | 2679MF687A | 2 | |
| RICE | INACTIVE INGREDIENT | 659G217HPG | 2 | |
| SELENIUM | INACTIVE INGREDIENT | H6241UJ22B | 2 | |
| THIAMINE MONONITRATE | INACTIVE INGREDIENT | 8K0I04919X | 2 | |
| UBIDECARENONE | INACTIVE INGREDIENT | EJ27X76M46 | 2 | |
| VINPOCETINE | INACTIVE INGREDIENT | 543512OBTC | 2 | |
| VITAMIN A PALMITATE | INACTIVE INGREDIENT | 1D1K0N0VVC | 2 | |
| VITIS VINIFERA SEED | INACTIVE INGREDIENT | C34U15ICXA | 2 | |
| ZINC GLUCONATE | INACTIVE INGREDIENT | U6WSN5SQ1Z | 2 | |
| ZINC OXIDE | INACTIVE INGREDIENT | SOI2LOH54Z | 2 |
Products#
Every source-derived product name is available through these pages.
- Tinnitus DX
- Calcarea carbonica, Carbo vegetabilis, Chininum sulphuricum, Cimicifuga racemosa, Cinchona officinalis, Coffea cruda, Graphites, Kali carbonicum,
- MAGNESIUM STEARATE
- OYSTER SHELL CALCIUM CARBONATE, CRUDE
- ACTIVATED CHARCOAL
- QUININE SULFATE
- QUININE
- BLACK COHOSH
- CINCHONA OFFICINALIS BARK
- ARABICA COFFEE BEAN
- GRAPHITE
- POTASSIUM CARBONATE
- POTASSIUM CATION
- LYCOPODIUM CLAVATUM SPORE
- SODIUM SALICYLATE
- SODIUM CATION
- SALICYLIC ACID
- VITAMIN A PALMITATE
- THIAMINE MONONITRATE
- NIACIN
- INOSITOL NIACINATE
- FOLIC ACID
- METHYLCOBALAMIN
- MAGNESIUM CITRATE
- MAGNESIUM OXIDE
- ZINC GLUCONATE
- ZINC OXIDE
- SELENIUM
- COPPER GLUCONATE
- MANGANESE
- ACETYLCYSTEINE
- IPRIFLAVONE
- GINKGO
- GINGER
- ALPHA LIPOIC ACID
- GARLIC
- AMINOBENZOIC ACID
- VINPOCETINE
- BLACK PEPPER
- UBIDECARENONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57520-0363 | 57520-0363-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| MAGNESIUM OXIDE | MAGNESIUM OXIDE | 3A3U0GI71G | TABLET / ORAL | 63 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 2 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, EXTENDED RELEASE / ORAL | 1229 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 14 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| GINGER | GINGER | C5529G5JPQ | SYRUP / ORAL | 0.05 ml/5ml | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / INTRAMUSCULAR | 16 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 14 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| GELATIN | GELATIN | 2G86QN327L | WAFER / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| MAGNESIUM OXIDE | MAGNESIUM OXIDE | 3A3U0GI71G | TABLET, EXTENDED RELEASE / ORAL | 25.74 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| MAGNESIUM OXIDE | MAGNESIUM OXIDE | 3A3U0GI71G | TABLET, FILM COATED / ORAL | 80 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SUPPOSITORY / VAGINAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER, FOR SUSPENSION / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | LOTION / TOPICAL | 16 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / INTRAVENOUS | 20 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / ORAL | 10932 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, LIQUID FILLED / ORAL | 1042 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, ORALLY DISINTEGRATING / ORAL | 120 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| MAGNESIUM OXIDE | MAGNESIUM OXIDE | 3A3U0GI71G | CAPSULE, EXTENDED RELEASE / ORAL | 75 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / SUBCUTANEOUS | 16 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | SOLUTION / RESPIRATORY (INHALATION) | 3.11 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET / ORAL | 46 mg | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | SUPPOSITORY / RECTAL | 375 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER / RESPIRATORY (INHALATION) | 100 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / INTRACAVITARY | 0.05 ml | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, ORALLY DISINTEGRATING / SUBLINGUAL | 13 mg | ||
| MAGNESIUM OXIDE | MAGNESIUM OXIDE | 3A3U0GI71G | CAPSULE, DELAYED RELEASE / ORAL | 78 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, EXTENDED RELEASE / ORAL | 239 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 14 mg | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | INJECTION / SUBCUTANEOUS | 0.02 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SOLUTION / INTRAVENOUS | 34.8 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER / ORAL | 100 mg | ||
| GELATIN | GELATIN | 2G86QN327L | ELIXIR / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| MAGNESIUM OXIDE | MAGNESIUM OXIDE | 3A3U0GI71G | CAPSULE / ORAL | 20 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | WAFER / ORAL | 66 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | INJECTION, SUSPENSION / SUBCUTANEOUS | NA | ||
| GELATIN | GELATIN | 2G86QN327L | SYSTEM / TOPICAL | 1050 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, DELAYED RELEASE / ORAL | 1791 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| a2b4738b-db33-4f58-80b6-e5fc163f3043 | 1e6d6cd5-ab14-4258-a0fe-5f6a3cae437f | 2011-03-30 | Warnings | a2b4738b-db33-4f58-80b6-e5fc163f3043 1e6d6cd5-ab14-4258-a0fe-5f6a3cae437f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
