Ear Ringing
FDA Label NDC 55714-2342

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 Ear Ringing (NDC 55714-2342). 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

Indications & Usage Section

Ear Ringing  Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.

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. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc - Active Ingredient Section

Aconitum nap. 10x, Baryta carb. 10x, Baryta mur. 10x, Capsicum 10x, Causticum 10x, Chenopodium anthelminticum 10x, Chininum sulphuricum 10x, Cinchona 10x, Glonoinum 10x, Graphites 10x, Hydrastis 10x, Kali bic. 10x, Kali mur.10x, Lycopodium 10x, Phosphorus 10x, Pulsatilla 10x, Salicylicum ac.10x, Tabacum 10x, Thiosinaminum 10x, Viola odorata 10x, Hydrastis 3x.

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 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

Otc - 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.

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

Package Label

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