Hemorrhoids Liquid
FDA Label NDC 55714-4845

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 55714-4845). 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.

Indications & Usage Section

Formulated for associated symptoms such as enlarged or bleeding hemorrhoidal veins, itching, inflammation, burning pain and pressure.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional.

Otc - Active Ingredient Section

Equal parts of Aesculus hippocastanum 11x, Echinacea 11x, Solidago virgaurea 11x, Urtica urens 11x, Aesculus hippocastanum 20x, Aloe 20x, Arsenicum album 20x, Bryonia 20x, Calcarea fluorica 20x, Capsicum annuum 20x, Collinsonia canadensis 20x, Crotalus horridus 20x, Hamamelis virginiana 20x, Hydrofluoricum acidum 20x, Hypericum perforatum 20x, Lachesis mutus 20x, Lycopodium clavatum 20x, Millefolium 20x, Naja tripudians 20x, Nux vomica 20x, Paeonia officinalis 20x, Plantago major 20x, Quercus glandium spiritus 20x, Ratanhia 20x, Vipera berus 20x, Elaps corallinus 35x.

Otc - Purpose Section

Formulated for associated symptoms such as enlarged or bleeding hemorrhoidal veins, itching, inflammation, burning pain and pressure.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

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

Package Label.

Package Label (R024 L01 4845)

Package Label (R024 L01 4845)

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