Indications & Usage Section
Hemorrhoids Formulated for symptoms associated with hemorrhoids such as difficult elimination, itching, inflammation, burning pain and pressure.
Hemorrhoids
FDA Label NDC 55714-2221
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 Hemorrhoids (NDC 55714-2221). 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 orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
Otc - Active Ingredient Section
Elaps corallinus 30x, Aesculus hipp.15x, Aloe 15x, Arsenicum alb. 15x, Bryonia 15x, Calc. fluor. 15x, Capsicum 15x, Collinsonia 15x, Crotalus horridus 15x, Hamamelis 15x, Hydrofluoricum acidum 15x, Hypericum 15x, Lachesis 15x, Lycopodium 15x, Millefolium 15x, Naja 15x, Nux vom. 15x, Paeonia 15x, Plantago 15x, Quercus glandium spiritus 15x, Ratanhia 15x, Vipera berus 15x, Aesculus hipp. 3x, Echinacea 3x, Solidago 3x, Urtica ur. 3x.
Otc - Purpose Section
Formulated for symptoms associated with hemorrhoids such as difficult elimination, itching, inflammation, burning pain and pressure.
Inactive Ingredient Section
Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.
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 (N011 P01)
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