Drug Facts:

Drug Facts

Composition & Product

Active Ingredients

Eschscholzia Californica (3 [hp_C]) Matricaria Chamomilla (6 [hp_C]) Artemisia Cina Flower (30 [hp_C]) Arabica Coffee Bean Strychnos Nux-vomica Seed Passiflora Incarnata Flowering Top Pulsatilla Pratensis Whole Strychnos Ignatii Seed Phosphate Ion Toxicodendron Pubescens Leaf

Inactive Ingredients

Water Alcohol

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Completed Since 2022-02-14 Until 2027-03-22

Medication Information

Description

Eschscholtzia Californica 3C, Chamomilla 3C, 6C, 30C, Cina 6C, 30C, Coffea Cruda 6C, 30C, Nux Vomica 6C, 30C, Passiflora Incarnata 6C, 30C, Pulsatilla (Pratensis) 6C, 30C, Ignatia Amara 30C, Kali Phosphoricum 30C, Rhus Tox 30C.

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.

Do not use if seal is broken or missing.

Questions:

MFD FOR:

The Wellness Center for Research

and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

Directions:

Spray orally, 4 to 6 sprays, at least 30 minutes before bed and 30 minutes after eating. Consult a physician for use in children under 12 years of age.

Indications:

Supports a reduction in stress-related sleep issues, nightmares, waking during the early morning hours. Temporary relief of nervousness, anxiety, restlessness. overactive mind, mood disorders, grief, muscular discomfort.

Active Ingredients:

Eschscholtzia Californica 3C, Chamomilla 3C, 6C, 30C, Cina 6C, 30C, Coffea Cruda 6C, 30C, Nux Vomica 6C, 30C, Passiflora Incarnata 6C, 30C, Pulsatilla (Pratensis) 6C, 30C, Ignatia Amara 30C, Kali Phosphoricum 30C, Rhus Tox 30C.

Inactive Ingredients:

Demineralized Water, 25% Organic Ethanol

Package Display Label:

Formulated by DR. Theresa Dale

NDC#: 50181-0080-1

Serene

Sleep

DR. DALE'S WELLNESS CENTER

Homeopathic

1 fluid oz. (30 ml)

Keep Out of Reach of Children Section

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Structured Label Content

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.

Do not use if seal is broken or missing.

Questions: (QUESTIONS:)

MFD FOR:

The Wellness Center for Research

and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

Directions: (DIRECTIONS:)

Spray orally, 4 to 6 sprays, at least 30 minutes before bed and 30 minutes after eating. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

Supports a reduction in stress-related sleep issues, nightmares, waking during the early morning hours. Temporary relief of nervousness, anxiety, restlessness. overactive mind, mood disorders, grief, muscular discomfort.

Active Ingredients: (ACTIVE INGREDIENTS:)

Eschscholtzia Californica 3C, Chamomilla 3C, 6C, 30C, Cina 6C, 30C, Coffea Cruda 6C, 30C, Nux Vomica 6C, 30C, Passiflora Incarnata 6C, 30C, Pulsatilla (Pratensis) 6C, 30C, Ignatia Amara 30C, Kali Phosphoricum 30C, Rhus Tox 30C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Organic Ethanol

Package Display Label: (PACKAGE DISPLAY LABEL:)

Formulated by DR. Theresa Dale

NDC#: 50181-0080-1

Serene

Sleep

DR. DALE'S WELLNESS CENTER

Homeopathic

1 fluid oz. (30 ml)

Keep Out of Reach of Children Section (KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "ESCHSCHOLZIA CALIFORNICA", "unii": "9315HN272X", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "MATRICARIA CHAMOMILLA", "unii": "G0R4UBI2ZZ", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "ARTEMISIA CINA FLOWER", "unii": "28M1820ACT", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "ARABICA COFFEE BEAN", "unii": "3SW678MX72", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "STRYCHNOS NUX-VOMICA SEED", "unii": "269XH13919", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "PASSIFLORA INCARNATA FLOWERING TOP", "unii": "CLF5YFS11O", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "PULSATILLA PRATENSIS WHOLE", "unii": "8E272251DI", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "STRYCHNOS IGNATII SEED", "unii": "1NM3M2487K", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "PHOSPHATE ION", "unii": "NK08V8K8HR", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "TOXICODENDRON PUBESCENS LEAF", "unii": "6IO182RP7A", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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. Do not use if seal is broken or missing.", "QUESTIONS:": "MFD FOR: The Wellness Center for Research and Education, Inc. 1237 S. Victoria Ave. Suite 169 Oxnard, CA 93035", "DIRECTIONS:": "Spray orally, 4 to 6 sprays, at least 30 minutes before bed and 30 minutes after eating. Consult a physician for use in children under 12 years of age.", "INDICATIONS:": "Supports a reduction in stress-related sleep issues, nightmares, waking during the early morning hours. Temporary relief of nervousness, anxiety, restlessness. overactive mind, mood disorders, grief, muscular discomfort.", "ACTIVE INGREDIENTS:": "Eschscholtzia Californica 3C, Chamomilla 3C, 6C, 30C, Cina 6C, 30C, Coffea Cruda 6C, 30C, Nux Vomica 6C, 30C, Passiflora Incarnata 6C, 30C, Pulsatilla (Pratensis) 6C, 30C, Ignatia Amara 30C, Kali Phosphoricum 30C, Rhus Tox 30C.", "INACTIVE INGREDIENTS:": "Demineralized Water, 25% Organic Ethanol", "PACKAGE DISPLAY LABEL:": "Formulated by DR. Theresa Dale NDC#: 50181-0080-1 Serene Sleep DR. DALE'S WELLNESS CENTER Homeopathic 1 fluid oz. (30 ml)", "KEEP OUT OF REACH OF CHILDREN SECTION": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information