{"active_ingredient":["ACTIVE INGREDIENTS: Aquilegia 4X, Avena 4X, Chamomilla 4X, Coffea cruda 200C, Cypripedium 4X, Humulus 4X, Kali phos 12X, Passiflora 4X, Valeriana 4X, Zinc met 12X."],"dosage_and_administration":["DIRECTIONS: Adults and children over 12: 2 sprays into the mouth at bedtime and if sleep is interrupted.Children Under 12: consult a health care professional."],"effective_time":"20251218","id":"cc630075-d315-46fe-a50d-3fb7f0215eb4","inactive_ingredient":["INACTIVE INGREDIENTS: Non-GMO Glycerin, organic alcohol 20% v/v, purified water."],"indications_and_usage":["INDICATIONS: Temporarily relieves the common symptoms of sleeplessness, including: º wakefulness º restlessness º emotional stress and anxiety º caffeine sensitivity"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN: Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"brand_name":["SleepEase"],"generic_name":["AQUILEGIA, AVENA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM, HUMULUS, KALI PHOS, PASSIFLORA, VALERIANA, ZINC MET"],"is_original_packager":[true],"manufacturer_name":["Eight & Company L.L.C"],"nui":["N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0006342","M0016962","M0516536","M0008672"],"package_ndc":["61096-2001-1"],"pharm_class_cs":["Allergens [CS]","Dietary Proteins [CS]","Plant Proteins [CS]","Seed Storage Proteins [CS]","Food Additives [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]"],"product_ndc":["61096-2001"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["cc630075-d315-46fe-a50d-3fb7f0215eb4"],"spl_set_id":["9bd5fdc8-56b3-4e94-bd2f-1bfa9475c2e6"],"substance_name":["AQUILEGIA VULGARIS","AVENA SATIVA FLOWERING TOP","MATRICARIA CHAMOMILLA WHOLE","ARABICA COFFEE BEAN","CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT","HOPS","DIBASIC POTASSIUM PHOSPHATE","PASSIFLORA INCARNATA FLOWERING TOP","VALERIAN","ZINC"],"unii":["8POZ61U1G2","MA9CQJ3F7F","G0R4UBI2ZZ","3SW678MX72","21Y9GZ1LZA","01G73H6H83","CI71S98N1Z","CLF5YFS11O","JWF5YAW3QW","J41CSQ7QDS"],"upc":["0361096000115"]},"other_safety_information":["OTHER INFORMATION: Do not use if the transparent seal around spray bottle is broken or missing."],"package_label_principal_display_panel":["PACKAGE LABEL DISPLAY: NDC 61096-2001-1 sprayology SleepEase RELIEVES RESTLESSNESS HOMEOPATHIC ORAL SPRAY 1.38 fl.oz (41 ml) SleepEase LBL SleepEase CNT"],"purpose":["PURPOSE: Temporarily relieves the common symptoms of sleeplessness, including: ° wakefulness ° restlessness ° emotional stress and anxiety ° caffeine sensitivity ° natural ° gluten free ° no artifical flavors or colors ° vegan ° no known negative side effects ° no known negative drug interactions"],"set_id":"9bd5fdc8-56b3-4e94-bd2f-1bfa9475c2e6","spl_product_data_elements":["SleepEase Aquilegia, Avena, Chamomilla, Coffea cruda, Cypripedium, Humulus, Kali phos, Passiflora, Valeriana, Zinc met AQUILEGIA VULGARIS AQUILEGIA VULGARIS AVENA SATIVA FLOWERING TOP AVENA SATIVA FLOWERING TOP MATRICARIA CHAMOMILLA WHOLE MATRICARIA CHAMOMILLA WHOLE ARABICA COFFEE BEAN ARABICA COFFEE BEAN CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT HOPS HOPS DIBASIC POTASSIUM PHOSPHATE PHOSPHATE ION PASSIFLORA INCARNATA FLOWERING TOP PASSIFLORA INCARNATA FLOWERING TOP VALERIAN VALERIAN ZINC ZINC GLYCERIN ALCOHOL WATER"],"version":"6","warnings":["WARNINGS: If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away."]}