Harmony Slumber

Harmony Slumber
SPL v1
SPL
SPL Set ID 7553ccad-c798-4430-8179-9b908eaceea1
Route
ORAL
Published
Effective Date 2016-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avena Sativa Flowering Top (6 [hp_X]) Matricaria Recutita (8 [hp_X]) Cypripedium Parvifolum Root (30 [hp_X]) Daphne Odora Bark (4 [hp_C]) Hops (6 [hp_C]) Hyoscyamus Niger Bromide Ion Phosphate Ion Lithium Cation Passiflora Incarnata Flowering Top Scutellaria Lateriflora Datura Stramonium Amber Ferula Sumbul Root Valerian Zanthoxylum Americanum Bark Ferrosoferric Phosphate Egg Phospholipids Manganese Cation (2+) Arsenic Cation (3+) Arabica Coffee Bean Strychnos Ignatii Seed Nutmeg Amanita Muscaria Fruiting Body Atropa Belladonna Anamirta Cocculus Seed Helleborus Niger Root Abrus Precatorius Seed Melissa Officinalis Viburnum Opulus Bark
Inactive Ingredients
Water Magnesium Potassium Alcohol Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-10-08

Description

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.


Medication Information

Warnings and Precautions

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.

Indications and Usage

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

Dosage and 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.

Description

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.

Section 50565-1

Keep out of reach of children.

Section 51727-6

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

Section 51945-4

Section 55105-1

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

Section 55106-9

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.

Section 60561-8

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]


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

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.

Section 60561-8 (60561-8)

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]


Advanced Ingredient Data


Raw Label Data

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