{"active_ingredient":["OTC - ACTIVE INGREDIENT SECTION Equal parts of Echinacea 6x, Hydrastis canadensis 6x, Passiflora incarnata 6x, Valeriana officinalis 6x, Belladonna 15x, Cantharis 15x, Causticum 15x, Equisetum hyemale 15x, Ferrum metallicum 15x, Gelsemium sempervirens 15x, Humulus lupulus 15x, Kali phosphoricum 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Plantago major 15x, Pulsatilla 15x, Rhus aromatica 15x, Sabal serrulata 15x, Thyroidinum 15x, Verbascum thapsus 15x."],"dosage_and_administration":["DOSAGE & ADMINISTRATION SECTION Directions: Children, ages 0 to 11, give 3 drops by mouth (ages 12 and up, give 6 drops) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a health professioal. Sensitive person begin with 1 drop and gradually increase to full dose."],"effective_time":"20250724","id":"3ab08f82-2c8b-2374-e063-6294a90a6a22","inactive_ingredient":["INACTIVE INGREDIENT SECTION USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%."],"indications_and_usage":["INDICATIONS & USAGE SECTION Formulated for symptoms of nighttime incontinence often related to fear, nervousness, muscle tone and trauma."],"keep_out_of_reach_of_children":["OTC - KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children."],"openfda":{"brand_name":["Bedwetting"],"generic_name":["ECHINACEA, HYDRASTIS CANADENSIS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, BELLADONNA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PLANTAGO MAJOR, PULSATILLA, RHUS AROMATICA, SABAL SERRULATA, THYROIDINUM, VERBASCUM THAPSUS"],"is_original_packager":[true],"manufacturer_name":["Newton Laboratories, Inc."],"nui":["N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0006342","M0016962","M0008672"],"package_ndc":["55714-1521-1"],"pharm_class_cs":["Allergens [CS]","Dietary Proteins [CS]","Plant 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":["55714-1521"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["3ab08f82-2c8b-2374-e063-6294a90a6a22"],"spl_set_id":["9d5f51d0-01e9-271c-e053-2995a90a63bc"],"substance_name":["ECHINACEA, UNSPECIFIED","VALERIAN","ATROPA BELLADONNA","LYTTA VESICATORIA","CAUSTICUM","EQUISETUM HYEMALE","IRON","GELSEMIUM SEMPERVIRENS ROOT","HOPS","DIBASIC POTASSIUM PHOSPHATE","GOLDENSEAL","SODIUM CHLORIDE","PLANTAGO MAJOR","ANEMONE PULSATILLA","TOXICODENDRON PUBESCENS LEAF","SAW PALMETTO","THYROID, UNSPECIFIED","VERBASCUM THAPSUS","PASSIFLORA INCARNATA FLOWERING TOP","LYCOPODIUM CLAVATUM SPORE"],"unii":["4N9P6CC1DX","JWF5YAW3QW","WQZ3G9PF0H","3Q034RO3BT","DD5FO1WKFU","59677RXH25","E1UOL152H7","639KR60Q1Q","01G73H6H83","CI71S98N1Z","ZW3Z11D0JV","451W47IQ8X","W2469WNO6U","I76KB35JEV","6IO182RP7A","J7WWH9M8QS","0B4FDL9I6P","C9TD27U172","CLF5YFS11O","C88X29Y479"]},"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 associated symptoms often related to fear, nervousness, muscle tone and trauma."],"questions":["QUESTIONS SECTION newtonlabs.net – Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013"],"set_id":"9d5f51d0-01e9-271c-e053-2995a90a63bc","spl_product_data_elements":["Bedwetting Echinacea, Hydrastis canadensis, Passiflora incarnata, Valeriana officinalis, Belladonna, Cantharis, Causticum, Equisetum hyemale, Ferrum metallicum, Gelsemium sempervirens, Humulus lupulus, Kali phosphoricum, Lycopodium clavatum, Natrum muriaticum, Plantago major, Pulsatilla, Rhus aromatica, Sabal serrulata, Thyroidinum, Verbascum thapsus ECHINACEA, UNSPECIFIED ECHINACEA, UNSPECIFIED ALCOHOL WATER VALERIAN VALERIAN ATROPA BELLADONNA ATROPA BELLADONNA LYTTA VESICATORIA LYTTA VESICATORIA CAUSTICUM CAUSTICUM EQUISETUM HYEMALE EQUISETUM HYEMALE IRON IRON GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT HOPS HOPS DIBASIC POTASSIUM PHOSPHATE POTASSIUM CATION GOLDENSEAL GOLDENSEAL SODIUM CHLORIDE SODIUM CATION PLANTAGO MAJOR PLANTAGO MAJOR ANEMONE PULSATILLA ANEMONE PULSATILLA TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF SAW PALMETTO SAW PALMETTO THYROID, UNSPECIFIED THYROID, UNSPECIFIED VERBASCUM THAPSUS VERBASCUM THAPSUS PASSIFLORA INCARNATA FLOWERING TOP PASSIFLORA INCARNATA FLOWERING TOP LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE"],"version":"3","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."]}