Indications & Usage Section
Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.
Ear Ringing Pellet
FDA Label NDC 55714-2589
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 55714-2589). 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 pellets by mouth (ages 6 to 11, give 3 pellets) as needed or as directed by a health professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.
Otc - Active Ingredient Section
Equal parts of Htdrastis 6x, 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.
Otc - Purpose Section
Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.
Inactive Ingredient Section
Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.
Questions Section
newtonlabs.net - Questions? 1.800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
Warnings Section
WARNINGS: Keep out of reach of children. Do no 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
If pregnant or breast-feeding, ask a doctor before use.
Otc - Keep Out Of Reach Of Children Section
Keep our of reach of children.
Package Label
Package Label (N077 P01)
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