Indications & Usage Section
Tinnitus Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.
Tinnitus
FDA Label NDC 55714-4584
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 55714-4584). 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, active ingredient section, purpose section, inactive ingredient section, questions? section, warnings section, 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: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 6 to 11, give 3 drops) as needed or as directed by a healthcare professional.
Active Ingredient Section
Aconitum nap. 15x, Baryta carb. 15x, Baryta mur. 15x, Capsicum 15x, Causticum 15x, Chenopodium anthelminticum 15x, Chininum sulphuricum 15x, Cinchona 15x, Glonoinum 15x, Graphites 15x, Hydrastis 15x, Kali bic. 15x, Kali mur.15x, Lycopodium 15x, Phosphorus 15x, Pulsatilla 15x, Salicylicum ac.15x, Tabacum 15x, Thiosinaminum 15x, Viola odorata 15x, Hydrastis 8x, Hydrastis 3x.
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 dispensing alcohol 20%.
Questions? Section
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256
Warnings Section
Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.
Pregnancy Or Breast Feeding Section
Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.
Keep Out Of Reach Of Children Section
Keep out of reach of children
Package Label
Package Label (R103 L01)
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