Product Name & Indications Section
Constipation Formulated for symptoms associated with acute or chronic constipation due to conditions such as poor diet, pregnancy, inactivity and rectal weakness.
Constipation
FDA Label NDC 55714-4426
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 55714-4426). 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 product name & indications section, direction section, active ingredient section, 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
Direction Section
Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional.
Active Ingredient Section
Abies nig. 20x, Aesculus hipp. 20x, Aloe 20x, Alumina 20x, Bryonia 20x, Carbo veg. 20x, Chelidonium majus 20x, Collinsonia 20x, Graphites 20x, Hydrastis 20x, Kali carb. 20x, Lycopodium 20x, Mag. mur. 20x, Mezereum 20x, Nux vom. 20x, Podoph. pelt. 20x, Rhamnus purshiana 20x, Sanicula 20x, Selenium 20x, Sepia 20x, Silicea 20x, Tabacum 20x, Veratrum alb. 20x, Zinc.met. 20x, Echinacea 8x, Iris versicolor 8x, Phytolacca 8x, Taraxacum 8x, Echinacea 3x, Iris versicolor 3x, Phytolacca 3x, Taraxacum 3x.
Purpose Section
Formulated for symptoms associated with acute or chronic constipation due to conditions such as poor diet, pregnancy, inactivity and rectal weakness.
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
Package Label (R014 L01)
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