Fem Remedy
FDA Label NDC 53852-0008

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Living Well Remedies, Llc for the product Fem Remedy (NDC 53852-0008). 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 dosage & administration, warnings, otc - keep out of reach of children, other safety information, otc - purpose, otc - active ingredient, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Dosage & Administration

Directions: Spray 3 times directly into mouth under your tongue. Take 3 times daily. Take additional doses as needed during hot flashes and night sweats. Continue until symptoms are relieved.

Warnings

Warnings: Stop use and ask a doctor, if symptoms persist or worsen. If pregnant or breast-feeding, consult a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Other Safety Information

Other: Do not use if safety seal is broken or missing.

Otc - Purpose

Uses: May help to relieve premenopause and menopause symptoms: hot flashes, night sweats, mood swings, low energy, irritability, difficulty sleeping, fatigue, sadness, hair loss, difficulty concentrating.

Otc - Active Ingredient

Ingredients: Official HPUS:Amyl nitrosum, Calcarea carbonica, Cimicifuga racemosa, Ferrum metallicum, Sanguinaria canadensis, Sepia. Equal volumes of each ingredient in 10C, 30C, LM1 potencies.

Inactive Ingredient

Inactive ingredients: Bio-Energetically enhanced pure water, citric acid, potassium sorbate.

Indications & Usage

Uses: May help to relieve premenopause and menopause symptoms:

  • hot flashes
  • night sweats
  • mood swings
  • low energy
  • irritability
  • difficulty sleeping
  • fatigue
  • sadness
  • hair loss
  • difficulty concentrating

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Distributed by

Living Well Remedies LLC

P.O. Box 704,

Franklin Lakes, NJ 07417

For more information visit:

www.livingWellRenedies.com

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