The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Tinnitus (NDC 57520-0363). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, information for patients, dosage & administration, inactive ingredient, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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: Tinnitus DX combines clinically researched ingredients to support maximum ear health and resolve noise problems in the ear.
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.
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.
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 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. In case of overdose, get medical help or contact a Poison Control Center right away.
PURPOSE: Tinnitus DX combines clinically researched ingredients to support maximum ear health and resolve noise problems in the ear.
Questions?
Call 877-212-7282
Dist By:
Vita Sciences
Princeton Sciences
Almont, NY 10952 USA
Tinnitus DX
Homeopathic Remedy
Relief from:
Ringing or buzzing in ears
Ear noise
Sensitivity to sound
Doctor Recommended
60 Capsules
Tinnitus Dx (Mm1)
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