{"active_ingredient":["OTC - ACTIVE INGREDIENT SECTION Equal parts of Passiflora incarnata 6x, Valeriana officinalis 6x, Absinthium 15x, Anacardium orientale 15x, Argentum nitricum 15x, Arsenicum album 15x, Belladonna 15x, Bryonia 15x, Calcarea carbonica 15x, Camphora 15x, Chamomilla 15x, Cimicifuga racemosa 15x, Cinchona officinalis 15x, Coffea cruda 15x, Cypripedium pubescens 15x, Gelsemium sempervirens 15x, Humulus lupulus 15x, Hyoscyamus niger 15x, Ignatia amara 15x, Kali bromatum 15x, Nux vomica 15x, Passiflora incarnata 15x, Pulsatilla 15x, Scutellaria lateriflora 15x, Sepia 15x, Thuja occidentalis 15x."],"dosage_and_administration":["DOSAGE & ADMINISTRATION SECTION Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose."],"effective_time":"20210201","id":"c6a0f7de-6eae-1ef8-e053-2995a90ad239","inactive_ingredient":["INACTIVE INGREDIENT SECTION Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets."],"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":["55714-2569-1"],"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":["55714-2569"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["c6a0f7de-6eae-1ef8-e053-2995a90ad239"],"spl_set_id":["c6a1163c-b21e-6474-e053-2995a90a1750"],"substance_name":["WORMWOOD","SEMECARPUS ANACARDIUM JUICE","SILVER NITRATE","ARSENIC TRIOXIDE","ATROPA BELLADONNA","MATRICARIA CHAMOMILLA","BRYONIA ALBA ROOT","OYSTER SHELL CALCIUM CARBONATE, CRUDE","CAMPHOR (NATURAL)","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","SEPIA OFFICINALIS JUICE","PASSIFLORA INCARNATA FLOWERING TOP","ANEMONE PULSATILLA","SCUTELLARIA LATERIFLORA WHOLE","THUJA OCCIDENTALIS LEAFY TWIG","VALERIAN"],"unii":["F84709P2XV","Y0F0BU8RDU","95IT3W8JZE","S7V92P67HO","WQZ3G9PF0H","G0R4UBI2ZZ","T7J046YI2B","2E32821G6I","N20HL7Q941","K73E24S6X9","S003A158SB","3SW678MX72","21Y9GZ1LZA","639KR60Q1Q","01G73H6H83","4WRK2153H3","1NM3M2487K","OSD78555ZM","269XH13919","QDL83WN8C2","CLF5YFS11O","I76KB35JEV","7BP4DH5PDC","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 after waking."],"questions":["QUESTIONS SECTION newtonlabs.net - Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013"],"set_id":"c6a1163c-b21e-6474-e053-2995a90a1750","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 SUCROSE WORMWOOD WORMWOOD SEMECARPUS ANACARDIUM JUICE SEMECARPUS ANACARDIUM JUICE SILVER NITRATE SILVER CATION ARSENIC TRIOXIDE ARSENIC CATION (3+) ATROPA BELLADONNA ATROPA BELLADONNA MATRICARIA CHAMOMILLA MATRICARIA CHAMOMILLA BRYONIA ALBA ROOT BRYONIA ALBA ROOT OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE CAMPHOR (NATURAL) CAMPHOR (NATURAL) 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 SEPIA OFFICINALIS JUICE SEPIA OFFICINALIS JUICE PASSIFLORA INCARNATA FLOWERING TOP PASSIFLORA INCARNATA FLOWERING TOP ANEMONE PULSATILLA ANEMONE PULSATILLA SCUTELLARIA LATERIFLORA WHOLE SCUTELLARIA LATERIFLORA WHOLE THUJA OCCIDENTALIS LEAFY TWIG THUJA OCCIDENTALIS LEAFY TWIG VALERIAN VALERIAN"],"version":"1","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."]}