{"active_ingredient":["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."],"dosage_and_administration":["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."],"effective_time":"20250606","id":"5b0d0301-c85f-4047-960f-ac9c150d827c","inactive_ingredient":["INACTIVE INGREDIENTS: Demineralized Water, 25% Organic Ethanol"],"indications_and_usage":["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."],"keep_out_of_reach_of_children":["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."],"openfda":{"brand_name":["Serene Sleep"],"generic_name":["ESCHSCHOLTZIA CALIFORNICA, CHAMOMILLA, CINA, COFFEA CRUDA, NUX VOMICA, PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), IGNATIA AMARA, KALI PHOSPHORICUM, RHUS TOX"],"is_original_packager":[true],"manufacturer_name":["The Wellness Center for Research a"],"nui":["N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0006342","M0016962","M0516536","N0000185001"],"package_ndc":["50181-0080-1"],"pharm_class_cs":["Allergens [CS]","Dietary Proteins [CS]","Plant Proteins [CS]","Seed Storage Proteins [CS]"],"pharm_class_epc":["Non-Standardized Food Allergenic Extract [EPC]","Non-Standardized Plant Allergenic Extract [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]","Increased IgG Production [PE]"],"product_ndc":["50181-0080"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["5b0d0301-c85f-4047-960f-ac9c150d827c"],"spl_set_id":["2d5bbd0d-9b50-45ce-aa23-05bd05b54645"],"substance_name":["ESCHSCHOLZIA CALIFORNICA WHOLE","MATRICARIA CHAMOMILLA WHOLE","ARTEMISIA CINA PRE-FLOWERING TOP","ARABICA COFFEE BEAN","STRYCHNOS NUX-VOMICA SEED","PASSIFLORA INCARNATA FLOWERING TOP","PULSATILLA PRATENSIS WHOLE","STRYCHNOS IGNATII SEED","DIBASIC POTASSIUM PHOSPHATE","TOXICODENDRON PUBESCENS LEAF"],"unii":["9315HN272X","G0R4UBI2ZZ","28M1820ACT","3SW678MX72","269XH13919","CLF5YFS11O","8E272251DI","1NM3M2487K","CI71S98N1Z","6IO182RP7A"]},"package_label_principal_display_panel":["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) Serene Sleep"],"purpose":["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."],"questions":["QUESTIONS: MFD FOR: The Wellness Center for Research and Education, Inc. 1237 S. Victoria Ave. Suite 169 Oxnard, CA 93035"],"set_id":"2d5bbd0d-9b50-45ce-aa23-05bd05b54645","spl_product_data_elements":["Serene Sleep Eschscholtzia Californica, Chamomilla, Cina, Coffea Cruda, Nux Vomica, Passiflora Incarnata, Pulsatilla (Pratensis), Ignatia Amara, Kali Phosphoricum, Rhus Tox ESCHSCHOLZIA CALIFORNICA WHOLE ESCHSCHOLZIA CALIFORNICA MATRICARIA CHAMOMILLA WHOLE MATRICARIA CHAMOMILLA ARTEMISIA CINA PRE-FLOWERING TOP ARTEMISIA CINA FLOWER ARABICA COFFEE BEAN ARABICA COFFEE BEAN STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED PASSIFLORA INCARNATA FLOWERING TOP PASSIFLORA INCARNATA FLOWERING TOP PULSATILLA PRATENSIS WHOLE PULSATILLA PRATENSIS WHOLE STRYCHNOS IGNATII SEED STRYCHNOS IGNATII SEED DIBASIC POTASSIUM PHOSPHATE PHOSPHATE ION TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF WATER ALCOHOL"],"version":"2","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."]}