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 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
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