Menopause
FDA Label NDC 55714-2234

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 55714-2234). 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

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. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc - Active Ingredient Section

Elaps corallinus 30x, Agnus 10x, Angelica sinensis radix 10x, Arsenicum alb. 10x, Bryonia 10x, Cantharis 10x, Caulophyllum 10x, Cimicifuga 10x, Cinchona 10x, Crotalus horridus 10x, Damiana 10x, Glonoinum 10x, Helonias dioica 10x, Ignatia 10x, Kali carb. 10x, Lachesis 10x, Naja 10x, Nux vom.10x, Phosphorus 10x, Pulsatilla 10x, Salix nigra 10x, Sanguinaria 10x, Sepia 10x, Echinacea 3x, Valeriana 3x.

Otc - 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. 

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

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