Harmony Slumber
FDA Label NDC 69631-0001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Life Harmony Energies, Llc. for the product Harmony Slumber (NDC 69631-0001). 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 otc - active ingredient, inactive ingredient, warnings, otc - keep out of reach of children, other safety information, otc - purpose, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient: Avena sativa, Chamomilla, Cypripedium pubescens, Daphne indica, Humulus lupulus, Hyoscyamus niger, Kali bromatum, Kali phosphoricum, Lithium muriaticum, Passiflora incarnata, Scutellaria lateriflora, Stramonium, Succinum, Sumbul, Valeriana officinalis, Xanthoxylum fraxineum at a 6X potency. Ferrum phosphoricum, Lecithin, Manganum phosphoricum at a 8X potency. Arsenicum album, Coffea cruda, Ignatia amara at a 30X potency. Nux moschata at 4C potency. Agaricus muscarius, Belladonna, Cocculus indicus, Helleborus niger, Jequirity, Melissa officinalis, Viburnum opulus at a 6C potency. Equal volumes of each ingredient.

Inactive Ingredient

Inactive Ingredient: Energetic mineralized water (magnesium, potassium). ethanol 13%(v/v). glycerin 8%(v/v).

Warnings

Warnings:If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Stop use and ask your doctor if symptoms persist or worsen. Store in a cool, dry place.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Other Safety Information

Other information: Tamper resistant for your protection. Use only if safety seal is intact.

*This product has not been clinically tested. Homeopathic provings for each HPUS ingredient are found in various materia medicas referenced in the FDA Compliance Policy Guide.

To reorder please visit: www.EnergeticElixirs.com

Dist. by:

Life Harmony Energies, LLC

1905 Lehigh St. Boulder, CO 80305

[email protected]

Otc - Purpose

Indications: ​A natural aid for falling asleep and sleeping through the night. Helps to restore and balance sleep cycle.

Dosage & Administration

Directions: Adults and children over 12 years of age use 4 to 8 sprays orally at bedtime. May take another dose during the night upon waking prematurely.

Indications & Usage

Indications: ​•​​A natural aid for falling asleep and sleeping through the night. •Helps to restore and balance sleep cycle.

* Please review the disclaimer below.