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.
Serene Sleep Spray
FDA Label NDC 50181-0080
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Wellness Center For Research A for the product Serene Sleep (NDC 50181-0080). 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 active ingredients:, indications:, warnings:, keep out of reach of children section, directions:, inactive ingredients:, questions:, package display label:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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.
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.
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.
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.
Inactive Ingredients:
Demineralized Water, 25% Organic Ethanol
Questions:
MFD FOR:
The Wellness Center for Research
and Education, Inc.
1237 S. Victoria Ave. Suite 169
Oxnard, CA 93035
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)
* Please review the disclaimer below.
