{"active_ingredient":["OTC - ACTIVE INGREDIENT SECTION Equal parts of Chamomilla 6x, Valeriana officinalis 6x, Aconitum napellus 15x, Apis mellifica 15x, Baptisia tinctoria 15x, Belladonna 15x, Borax 15x, Bryonia 15x, Calcarea carbonica 15x, Calcarea phosphorica 15x, Chamomilla 15x, Chelidonium majus 15x, Coffea cruda 15x, Collinsonia canadensis 15x, Colocynthis 15x, Kreosotum 15x, Magnesia phosphorica 15x, Nux vomica 15x, Podophyllum peltatum 15x, Rheum 15x, Scutellaria lateriflora 15x, Silicea 15x, Terebinthina 15x, Zingiber officinale 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) as needed or a directed by a health professional. Sensitive person begin with 1 drop and gradually increase to full dose."],"effective_time":"20251106","id":"42f36188-97a7-5c4b-e063-6394a90ae52d","inactive_ingredient":["INACTIVE INGREDIENT SECTION USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%"],"indications_and_usage":["INDICATIONS AND USAGE SECTION Formuated for associated symptoms such as inconsolable crying, painful and swollen gums and sleeplessness."],"keep_out_of_reach_of_children":["OTC - KEEP OUT OF REACH OF CHILDREN SECTION WARNINGS: Keep out of reach of children."],"openfda":{"brand_name":["Teething-Colic"],"generic_name":["CHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALE"],"is_original_packager":[true],"manufacturer_name":["Newton Laboratories, Inc."],"nui":["N0000185021","N0000175629","N0000184306","N0000185001","M0000728","M0002274","N0000185371","N0000185375","M0006342","M0016962","M0516536","M0008672"],"package_ndc":["55714-1530-1"],"pharm_class_cs":["Allergens [CS]","Bee Venoms [CS]","Dietary Proteins [CS]","Plant Proteins [CS]","Seed Storage Proteins [CS]","Food Additives [CS]"],"pharm_class_epc":["Standardized Insect Venom Allergenic Extract [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":["55714-1530"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["42f36188-97a7-5c4b-e063-6394a90ae52d"],"spl_set_id":["9db30229-3031-ff10-e053-2995a90aff75"],"substance_name":["VALERIAN","COLLINSONIA CANADENSIS ROOT","APIS MELLIFERA","BAPTISIA TINCTORIA ROOT","ATROPA BELLADONNA","SODIUM BORATE","BRYONIA ALBA ROOT","OYSTER SHELL CALCIUM CARBONATE, CRUDE","TRIBASIC CALCIUM PHOSPHATE","MATRICARIA CHAMOMILLA","CHELIDONIUM MAJUS","ARABICA COFFEE BEAN","WOOD CREOSOTE","MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE","STRYCHNOS NUX-VOMICA SEED","PODOPHYLLUM","RHEUM OFFICINALE ROOT","SCUTELLARIA LATERIFLORA WHOLE","SILICON DIOXIDE","TURPENTINE OIL","GINGER","CITRULLUS COLOCYNTHIS FRUIT PULP","ACONITUM NAPELLUS"],"unii":["JWF5YAW3QW","O2630F3XDR","7S82P3R43Z","5EF0HWI5WU","WQZ3G9PF0H","91MBZ8H3QO","T7J046YI2B","2E32821G6I","91D9GV0Z28","G0R4UBI2ZZ","7E889U5RNN","3SW678MX72","3JYG22FD73","HF539G9L3Q","269XH13919","2S713A4VP3","A47JP5ZG9M","7BP4DH5PDC","ETJ7Z6XBU4","C5H0QJ6V7F","C5529G5JPQ","23H32AOH17","U0NQ8555JD"]},"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 Formuated for associated symptoms such as inconsolable crying, painful and swollen gums and sleeplessness."],"questions":["QUESTIONS SECTION newtonlabs.net – Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013"],"set_id":"9db30229-3031-ff10-e053-2995a90aff75","spl_product_data_elements":["Teething-Colic Chamomilla, Valeriana officinalis, Aconitum napellus, Apis mellifica, Baptisia tinctoria, Belladonna, Borax, Bryonia, Calcarea carbonica, Calcarea phosphorica, Chamomilla, Chelidonium majus, Coffea cruda, Collinsonia canadensis, Colocynthis, Kreosotum, Magnesia phosphorica, Nux vomica, Podophyllum peltatum, Rheum, Scutellaria lateriflora, Silicea, Terebinthina, Zingiber officinale VALERIAN VALERIAN COLLINSONIA CANADENSIS ROOT COLLINSONIA CANADENSIS ROOT APIS MELLIFERA APIS MELLIFERA BAPTISIA TINCTORIA ROOT BAPTISIA TINCTORIA ROOT ATROPA BELLADONNA ATROPA BELLADONNA SODIUM BORATE BORATE ION BRYONIA ALBA ROOT BRYONIA ALBA ROOT OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE TRIBASIC CALCIUM PHOSPHATE PHOSPHATE ION MATRICARIA CHAMOMILLA MATRICARIA CHAMOMILLA CHELIDONIUM MAJUS CHELIDONIUM MAJUS ARABICA COFFEE BEAN ARABICA COFFEE BEAN WATER WOOD CREOSOTE WOOD CREOSOTE MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE MAGNESIUM CATION STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED PODOPHYLLUM PODOPHYLLUM RHEUM OFFICINALE ROOT RHEUM OFFICINALE ROOT ALCOHOL SCUTELLARIA LATERIFLORA WHOLE SCUTELLARIA LATERIFLORA WHOLE SILICON DIOXIDE SILICON DIOXIDE TURPENTINE OIL TURPENTINE OIL GINGER GINGER CITRULLUS COLOCYNTHIS FRUIT PULP CITRULLUS COLOCYNTHIS FRUIT PULP ACONITUM NAPELLUS ACONITUM NAPELLUS"],"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."]}