Menopause
FDA Label NDC 55714-4456

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 Menopause (NDC 55714-4456). 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, active ingredient section, purpose section, inactive ingredient section, questions? section, warnings section, pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Indications & Usage Section

Menopause  Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.

Dosage & Administration Section

Directions: ORAL USE ONLY - SHAKE WELL.  Adults, take 6 drops orally one to four times daily or as directed by a healthcare professional.

Active Ingredient Section

Elaps corallinus 35x, Agnus 15x, Angelica sinensis radix 15x, Arsenicum alb. 15x, Bryonia 15x, Cantharis 15x, Caulophyllum 15x, Cimicifuga 15x, Cinchona 15x, Crotalus horridus 15x, Damiana 15x, Glonoinum 15x, Helonias dioica 15x, Ignatia 15x, Kali carb. 15x, Lachesis 15x, Naja 15x, Nux vom.15x, Phosphorus 15x, Pulsatilla 15x, Salix nigra 15x, Sanguinaria 15x, Sepia 15x, Echinacea 8x, Valeriana 8x, Echinacea 3x, Valeriana3x.

Purpose Section

Formulated for symptoms associated with menopause such as hot flashes, decreased libido, insomnia, mood swings, discomfort and fatigue.

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.  

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. 

Keep Out Of Reach Of Children Section

Keep out of reach of children.

Package Label

Package Label (R029 L01)

Package Label (R029 L01)

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