FDA Label for Tinnitus

View Indications, Usage & Precautions

Tinnitus Product Label

The following document was submitted to the FDA by the labeler of this product Newton Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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




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