Indications And Usage Section
Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.
Constipation Pellet
FDA Label NDC 55714-1723
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 Constipation (NDC 55714-1723). 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 Echinacea 6x, Iris versicolor 6x, Phytolacca decandra 6x, Taraxacum officinale 6x, Abies nigra 15x, Aesculus hippocastanum 15x, Aloe 15x, Alumina 15x, Bryonia 15x, Carbo vegetabilis 15x, Chelidonium majus 15x, Collinsonia canadensis 15x, Graphites 15x, Hydrastis canadensis 15x, Kali carbonicum 15x, Lycopodium clavatum 15x, Magnesia muriatica 15x, Mezereum 15x, Nux vomica 15x, Podophyllum peltatum 15x, Rhamnus purshiana 15x, Sanicula 15x, Selenium metallicum 15x, Sepia 15x, Silicea 15x, Tabacum 15x, Veratrum album 15x, Zincum metallicum 15x.
Otc - Purpose Section
Formulated for associated symptoms such as difficult elimination, hard stools, pain, tenderness, pressure and irritability.
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. 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.
Package Label
Package Label (F008 P01)
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