Indications & Usage Section
Formulated for associated symptoms such as mouth sores, bad breath, toothache, inflammation and gum sensitivity.
Teeth-gums Pellet
FDA Label NDC 55714-2529
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 Teeth-gums (NDC 55714-2529). 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, otc - active ingredient section, otc - purpose section, inactive ingredient section, questions section, warnings section, otc - pregnancy or breast feeding section, otc - keep out of reach of children section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient Section
Equal parts of Chamomilla 6x, Echinacea 6x, Aconitum napellus 15x, Arnica montana 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Belladonna 15x, Bryonia 15x, Calendula officinalis 15x, Chamomilla 15x, Chelidonium majus 15x, Crotalus horridus 15x, Gelsemium sempervirens 15x, Hepar sulphuris calcareum 15x, Kreosotum 15x, Mercurius vivus 15x, Myrrha 15x, Nux vomica 15x, Phosphorus 15x, Phytolacca decandra 15x, Plantago major 15x, Rhus toxicodendron 15x, Silicea 15x, Staphysagria 15x.
Otc - Purpose Section
Formulated for associated symptoms such as mouth sores, bad breath, toothache, inflammation and gum sensitivity.
Inactive Ingredient Section
Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.
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
If pregnant or breast-feeding, ask a doctor before use.
Otc - Keep Out Of Reach Of Children Section
Keep out of reach of children.
Dosage & Administration Section
Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive person begin with 1 pellet and gradually increase to full dose.
Package Label
Package Label (N042 P01)
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