Indications & Usage Section
Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.
Tinnitus Liquid
FDA Label NDC 55714-4857
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Tinnitus (NDC 55714-4857). 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 indications & usage section, dosage & administration section, otc - active ingredient section, otc - purpose section, inactive ingredient section, questions section, warnings section, otc - pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration Section
Directions: Ages 12 and up, take 6 drops by mouth (ages 6 to 11, give 3 drops) as needed or as directed by a health professional.
Otc - Active Ingredient Section
Equal parts of Hydrastis canadensis 11x, Aconitum napellus 20x, Baryta carbonica 20x, Baryta muriatica 20x, Capsicum annuum 20x, Causticum 20x, Chenopodium anthelminticum 20x, Chininum sulphuricum 20x, Cinchona officinalis 20x, Glonoinum 20x, Graphites 20x, Hydrastis canadensis 20x, Kali bichromicum 20x, Kali muriaticum 20x, Lycopodium clavatum 20x, Phosphorus 20x, Pulsatilla 20x, Salicylicum acidum 20x, Tabacum 20x, Thiosinaminum 20x, Viola odorata 20x.
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
Package Label (R103 L01)
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