Tinnitus
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2020-12-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:03:53
Label at a glance#
ProductTinnitus
Active ingredientACONITUM NAPELLUS, BARIUM CARBONATE, BARIUM CHLORIDE DIHYDRATE, CAPSICUM, CAUSTICUM, DYSPHANIA AMBROSIOIDES, QUININE SULFATE, CINCHONA OFFICINALIS BARK, NITROGLYCERIN, GRAPHITE, GOLDENSEAL, POTASSIUM DICHROMATE, POTASSIUM CHLORIDE, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, ANEMONE PULSATILLA, SALICYLIC ACID, TOBACCO LEAF, ALLYLTHIOUREA, VIOLA ODORATA
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times a day or as directed by a health professional.
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Hydrastis canadensis 11x, Aconitum napellus 15x, Baryta carbonica 15x, Baryta muriatica 15x, Capsicum annuum 15x, Causticum 15x, Chenopodium anthelminticum 15x, Chininum sulphuricum 15x, Cinchona officinalis 15x, Glonoinum 15x, Graphites 15x, Hydrastis canadensis 15x, Kali bichromicum 15x, Kali muriaticum 15x, Lycopodium clavatum 15x, Phosphorus 15x, Pulsatilla 15x, Salicylicum acidum 15x, Tabacum 15x, Thiosinaminum 15x, Viola odorata 15x.
OTC - PURPOSE SECTION
Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%
QUESTIONS SECTION
newtonlabs.net -Questions? 800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
WARNINGS SECTION
WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.
OTC - PREGNANCY OR BREAST FEEDING SECTION
WARNINGS: If pregnant or breast-feeding, ask a doctor before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
WARNINGS: Keep out of reach of children.
PACKAGE LABEL
Products#
Every source-derived product name is available through these pages.
- Tinnitus
- Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac., Tabacum, Thiosinaminum, Viola odorata
- ALCOHOL
- ACONITUM NAPELLUS
- BARIUM CARBONATE
- BARIUM CATION
- BARIUM CHLORIDE DIHYDRATE
- CAPSICUM
- CAUSTICUM
- DYSPHANIA AMBROSIOIDES
- QUININE SULFATE
- QUININE
- CINCHONA OFFICINALIS BARK
- NITROGLYCERIN
- GRAPHITE
- GOLDENSEAL
- POTASSIUM DICHROMATE
- DICHROMATE ION
- POTASSIUM CHLORIDE
- POTASSIUM CATION
- LYCOPODIUM CLAVATUM SPORE
- PHOSPHORUS
- ANEMONE PULSATILLA
- SALICYLIC ACID
- TOBACCO LEAF
- ALLYLTHIOUREA
- VIOLA ODORATA
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4808 | 55714-4808-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| ACONITUM NAPELLUS | U0NQ8555JD | ACTIB |
| BARIUM CARBONATE | 6P669D8HQ8 | ACTIB |
| BARIUM CHLORIDE DIHYDRATE | EL5GJ3U77E | ACTIB |
| CAPSICUM | 00UK7646FG | ACTIB |
| CAUSTICUM | DD5FO1WKFU | ACTIB |
| DYSPHANIA AMBROSIOIDES | 4H5RSU087I | ACTIB |
| QUININE SULFATE | KF7Z0E0Q2B | ACTIB |
| CINCHONA OFFICINALIS BARK | S003A158SB | ACTIB |
| NITROGLYCERIN | G59M7S0WS3 | ACTIB |
| GRAPHITE | 4QQN74LH4O | ACTIB |
| GOLDENSEAL | ZW3Z11D0JV | ACTIB |
| POTASSIUM DICHROMATE | T4423S18FM | ACTIB |
| POTASSIUM CHLORIDE | 660YQ98I10 | ACTIB |
| LYCOPODIUM CLAVATUM SPORE | C88X29Y479 | ACTIB |
| PHOSPHORUS | 27YLU75U4W | ACTIB |
| ANEMONE PULSATILLA | I76KB35JEV | ACTIB |
| SALICYLIC ACID | O414PZ4LPZ | ACTIB |
| TOBACCO LEAF | 6YR2608RSU | ACTIB |
| ALLYLTHIOUREA | 706IDJ14B7 | ACTIB |
| VIOLA ODORATA | AET12U8B74 | ACTIB |
| WATER | 059QF0KO0R | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| 25407c62-534b-16b5-e063-6294a90ad3b2 | 999a0e3f-bd4a-12dc-e053-2995a90a0214 | 2024-10-24 | Warnings | 999a0e3f-bd4a-12dc-e053-2995a90a0214 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.