{"active_ingredient":["OTC - ACTIVE INGREDIENT SECTION Equal parts of Passiflora incarnata 11x, Valeriana officinalis 11x, Absinthium 20x, Anacardium orientale 20x, Argentum nitricum 20x, Bryonia 20x, Calcarea carbonica 20x, Camphora 20x, Chamomilla 20x, Cimicifuga racemosa 20x, Cinchona officinalis 20x, Coffea cruda 20x, Cypripedium pubescen 20x, Gelsemium sempervirens 20x, Humulus lupulus 20x, Hyoscyamus niger 20x, Ignatia amara 20x, Kali bromatum 20x, Passiflora incarnata 20x, Pulsatilla 20x, Scutellaria lateriflora 20x, Sepia 20x, Thuja occidentalis 20x, Arsenicum album 20x, Belladonna 20x, Nux vomica 20x"],"dosage_and_administration":["DOSAGE & ADMINISTRATION SECTION Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a health professional."],"effective_time":"20250918","id":"3f17fee1-6d69-aec2-e063-6294a90a02ed","inactive_ingredient":["INACTIVE INGREDIENT SECTION Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%."],"indications_and_usage":["INDICATIONS & USAGE SECTION Formulated for symptoms associated with sleeplessness such as frequent waking, restlessness and the inability to fall asleep or return to sleep after waking."],"keep_out_of_reach_of_children":["OTC - KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children."],"openfda":{"brand_name":["I-Sleep"],"generic_name":["ABSINTHIUM, ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BRYONIA, CALC. CARB., CAMPHORA, CHAMOMILLA, CIMICIFUGA, CINCHONA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HUMULUS, HYOSCYAMUS, IGNATIA, KALI BROM., NUX VOM., PASSIFLORA, PULSATILLA, SCUTELLARIA LATERIFLORA, SEPIA, THUJA OCC., VALERIANA"],"is_original_packager":[true],"manufacturer_name":["Newton Laboratories, Inc."],"nui":["N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0006342","M0016962","M0516536","M0008672","N0000185001"],"package_ndc":["55714-4844-1"],"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]","Increased IgG Production [PE]"],"product_ndc":["55714-4844"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["3f17fee1-6d69-aec2-e063-6294a90a02ed"],"spl_set_id":["c6f053fe-8b59-7226-e053-2995a90a8093"],"substance_name":["WORMWOOD","SEMECARPUS ANACARDIUM JUICE","SILVER NITRATE","ARSENIC TRIOXIDE","ATROPA BELLADONNA","BRYONIA ALBA ROOT","OYSTER SHELL CALCIUM CARBONATE, CRUDE","CAMPHOR (NATURAL)","MATRICARIA CHAMOMILLA","BLACK COHOSH","CINCHONA OFFICINALIS BARK","ARABICA COFFEE BEAN","CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT","GELSEMIUM SEMPERVIRENS ROOT","HOPS","HYOSCYAMUS NIGER","STRYCHNOS IGNATII SEED","POTASSIUM BROMIDE","STRYCHNOS NUX-VOMICA SEED","PASSIFLORA INCARNATA FLOWERING TOP","ANEMONE PULSATILLA","SCUTELLARIA LATERIFLORA WHOLE","SEPIA OFFICINALIS JUICE","THUJA OCCIDENTALIS LEAFY TWIG","VALERIAN"],"unii":["F84709P2XV","Y0F0BU8RDU","95IT3W8JZE","S7V92P67HO","WQZ3G9PF0H","T7J046YI2B","2E32821G6I","N20HL7Q941","G0R4UBI2ZZ","K73E24S6X9","S003A158SB","3SW678MX72","21Y9GZ1LZA","639KR60Q1Q","01G73H6H83","4WRK2153H3","1NM3M2487K","OSD78555ZM","269XH13919","CLF5YFS11O","I76KB35JEV","7BP4DH5PDC","QDL83WN8C2","1NT28V9397","JWF5YAW3QW"]},"package_label_principal_display_panel":["PACKAGE LABEL Package label"],"pregnancy_or_breast_feeding":["OTC - PREGNANCY OR BREAST FEEDING SECTION If pregnant or breast-feeding , ask a doctor before use."],"purpose":["OTC - PURPOSE SECTION Formulated for symptoms associated with sleeplessness such as frequent waking, restlessness and the inability to fall asleep or return to sleep after waking."],"questions":["QUESTIONS SECTION newtonlabs.net – Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013"],"set_id":"c6f053fe-8b59-7226-e053-2995a90a8093","spl_product_data_elements":["I-Sleep Absinthium, Anacardium orientale, Arg. nit., Arsenicum alb., Belladonna, Bryonia, Calc. carb., Camphora, Chamomilla, Cimicifuga, Cinchona, Coffea cruda, Cypripedium, Gelsemium, Humulus, Hyoscyamus, Ignatia, Kali brom., Nux vom., Passiflora, Pulsatilla, Scutellaria lateriflora, Sepia, Thuja occ., Valeriana ALCOHOL WORMWOOD WORMWOOD SEMECARPUS ANACARDIUM JUICE SEMECARPUS ANACARDIUM JUICE SILVER NITRATE SILVER CATION ARSENIC TRIOXIDE ARSENIC CATION (3+) ATROPA BELLADONNA ATROPA BELLADONNA BRYONIA ALBA ROOT BRYONIA ALBA ROOT OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE CAMPHOR (NATURAL) CAMPHOR (NATURAL) MATRICARIA CHAMOMILLA MATRICARIA CHAMOMILLA BLACK COHOSH BLACK COHOSH CINCHONA OFFICINALIS BARK CINCHONA OFFICINALIS BARK ARABICA COFFEE BEAN ARABICA COFFEE BEAN CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT HOPS HOPS HYOSCYAMUS NIGER HYOSCYAMUS NIGER STRYCHNOS IGNATII SEED STRYCHNOS IGNATII SEED POTASSIUM BROMIDE BROMIDE ION STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED PASSIFLORA INCARNATA FLOWERING TOP PASSIFLORA INCARNATA FLOWERING TOP ANEMONE PULSATILLA ANEMONE PULSATILLA SCUTELLARIA LATERIFLORA WHOLE SCUTELLARIA LATERIFLORA WHOLE SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG VALERIAN VALERIAN WATER"],"version":"2","warnings":["WARNINGS SECTION WARNINGS: Keep out of reach of children . Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding , ask a doctor before use."]}