Indications And Usage Section
Formuated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and other related symptoms.
Teething-colic Pellet
FDA Label NDC 55714-1730
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 Teething-colic (NDC 55714-1730). 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 and 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: Children, ages 0 to 11, give 3 pellets by mouth (ages 12 and up, give 6 pellets) as needed or a 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.
Otc - Active Ingredient Section
Equal parts of Chamomilla 6x, Valeriana officinalis 6x, Aconitum napellus 15x, Apis mellifica 15x, Baptisia tinctoria 15x, Belladonna 15x, Borax 15x, Bryonia 15x, Calcarea carbonica 15x, Calcarea phosphorica 15x, Chamomilla 15x, Chelidonium majus 15x, Coffea cruda 15x, Collinsonia canadensis 15x, Colocynthis 15x, Kreosotum 15x, Magnesia phosphorica 15x, Nux vomica 15x, Podophyllum peltatum 15x, Rheum 15x, Scutellaria lateriflora 15x, Silicea 15x, Terebinthina 15x, Zingiber officinale 15x.
Otc - Purpose Section
Formuated for associated symptoms such as inconsolable crying, painful and swollen gums, sleeplessness and other related symptoms.
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
WARNINGS: Keep out of reach of children.
Package Label
Package Label (F026 P01)
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