{"active_ingredient":["Active ingredients Purpose Arnica Montana 30X HPUS sore, sensitive or swelling gums Calcarea Carbonica 12X HPUS teething, sore, sensitive or swelling gums Calcarea Phosphorica 12X HPUS teething, sensitive, swelling gums, oral pain Chamomilla 12X HPUS sore, sensitive or swelling gums Coffea Cruda 6X HPUS oral pain, irritability Ferrum Phosphoricum 12X HPUS oral discomfort, swelling gums Magnesia Phosphorica 12X HPUS oral pain, occasional sleeplessness Silicea 12X HPUS oral pain at night, occasional sleeplessness \"HPUS\" is the Homeopathic Pharmacopoeia of the United States."],"active_ingredient_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"bold\">Active ingredients</content></td><td><content styleCode=\"bold\">Purpose</content></td></tr><tr><td>Arnica Montana 30X HPUS</td><td>sore, sensitive or swelling gums</td></tr><tr><td>Calcarea Carbonica 12X HPUS</td><td>teething, sore, sensitive or swelling gums</td></tr><tr><td>Calcarea Phosphorica 12X HPUS</td><td>teething, sensitive, swelling gums, oral pain</td></tr><tr><td>Chamomilla 12X HPUS</td><td>sore, sensitive or swelling gums</td></tr><tr><td>Coffea Cruda 6X HPUS</td><td>oral pain, irritability</td></tr><tr><td>Ferrum Phosphoricum 12X HPUS</td><td>oral discomfort, swelling gums</td></tr><tr><td>Magnesia Phosphorica 12X HPUS</td><td>oral pain, occasional sleeplessness</td></tr><tr><td>Silicea 12X HPUS</td><td>oral pain at night, occasional sleeplessness</td></tr></tbody></table>"],"dosage_and_administration":["Directions ■ Use as directed. Children under 6 months At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist, 2 tablets every 4 hours during the night until relieved. Children 6 months to under 3 years At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist, 3 tablets every 4 hours during the night until relieved"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>Children under   6 months </td><td>At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,   2 tablets every 4 hours during the night until relieved. </td></tr><tr><td>Children 6 months   to under 3 years </td><td>At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,   3 tablets every 4 hours during the night until relieved </td></tr></tbody></table>"],"effective_time":"20250317","id":"308ccf50-c319-2cd0-e063-6394a90aa99e","inactive_ingredient":["Inactive ingredients Acacia Gum, Lactose."],"indications_and_usage":["Uses ■ Helps temporarily relieve symptoms of oral pain or discomfort in children, including: ■ teething ■ gum sensitivity ■ swelling or soreness of gums ■ irritability ■ occasional sleeplessness"],"keep_out_of_reach_of_children":["Keep out of reach of children"],"openfda":{"brand_name":["Baby Nighttime Oral Pain Relief"],"generic_name":["ARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, SILICON DIOXIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, FERROSOFERRIC PHOSPHATE, ARABICA COFFEE BEAN AND OYSTER SHELL CALCIUM CARBONATE, CRUDE"],"is_original_packager":[true],"manufacturer_name":["Hyland' Inc."],"nui":["N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0006342","M0016962","M0516536"],"package_ndc":["54973-3324-1","54973-3324-4"],"pharm_class_cs":["Allergens [CS]","Dietary Proteins [CS]","Plant Proteins [CS]","Seed Storage Proteins [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":["54973-3324"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["308ccf50-c319-2cd0-e063-6394a90aa99e"],"spl_set_id":["58ef86b7-5b38-1591-e053-2991aa0aa53e"],"substance_name":["OYSTER SHELL CALCIUM CARBONATE, CRUDE","TRIBASIC CALCIUM PHOSPHATE","MATRICARIA CHAMOMILLA","SILICON DIOXIDE","ARNICA MONTANA","FERROSOFERRIC PHOSPHATE","ARABICA COFFEE BEAN","MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE"],"unii":["2E32821G6I","91D9GV0Z28","G0R4UBI2ZZ","ETJ7Z6XBU4","O80TY208ZW","91GQH8I5F7","3SW678MX72","HF539G9L3Q"]},"other_safety_information":["DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING."],"package_label_principal_display_panel":["Principal Display Panel Hyland's NATURALS •baby• Oral Pain Relief* NIGHTTIM E NO BENZOCAINE, DYES or PARABENS Sleeplessness Teething Pain Oral Discomfort Irritability Swelling 0+ Months 125 QUICK-DISSOLVING TABLETS HOMEOPATHIC BNPR Carton Art"],"purpose":["Helps temporarily relieve symptoms of oral pain or discomfort in children, including: teething, gum sensitivity, swelling or soreness of gums, irritability, occasional sleeplessness."],"questions":["Questions? www.hylands.com or care@hylands.com"],"set_id":"58ef86b7-5b38-1591-e053-2991aa0aa53e","spl_product_data_elements":["Baby Nighttime Oral Pain Relief Arnica Montana, Tribasic Calcium Phosphate, Matricaria Chamomilla, Silicon Dioxide, Magnesium Phosphate, Dibasic Trihydrate, Ferrosoferric Phosphate, Arabica Coffee Bean and Oyster Shell Calcium Carbonate, Crude LACTOSE MONOHYDRATE ANHYDROUS LACTOSE ACACIA OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE TRIBASIC CALCIUM PHOSPHATE PHOSPHATE ION MATRICARIA CHAMOMILLA MATRICARIA CHAMOMILLA SILICON DIOXIDE SILICON DIOXIDE ARNICA MONTANA ARNICA MONTANA FERROSOFERRIC PHOSPHATE FERROSOFERRIC PHOSPHATE ARABICA COFFEE BEAN ARABICA COFFEE BEAN MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE MAGNESIUM CATION"],"spl_unclassified_section":["Drug Facts Active ingredients Purpose Arnica Montana 30X HPUS sore, sensitive or swelling gums Calcarea Carbonica 12X HPUS teething, sore, sensitive or swelling gums Calcarea Phosphorica 12X HPUS teething, sensitive, swelling gums, oral pain Chamomilla 12X HPUS sore, sensitive or swelling gums Coffea Cruda 6X HPUS oral pain, irritability Ferrum Phosphoricum 12X HPUS oral discomfort, swelling gums Magnesia Phosphorica 12X HPUS oral pain, occasional sleeplessness Silicea 12X HPUS oral pain at night, occasional sleeplessness \"HPUS\" is the Homeopathic Pharmacopoeia of the United States.","*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED."],"spl_unclassified_section_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"bold\">Active ingredients</content></td><td><content styleCode=\"bold\">Purpose</content></td></tr><tr><td>Arnica Montana 30X HPUS</td><td>sore, sensitive or swelling gums</td></tr><tr><td>Calcarea Carbonica 12X HPUS</td><td>teething, sore, sensitive or swelling gums</td></tr><tr><td>Calcarea Phosphorica 12X HPUS</td><td>teething, sensitive, swelling gums, oral pain</td></tr><tr><td>Chamomilla 12X HPUS</td><td>sore, sensitive or swelling gums</td></tr><tr><td>Coffea Cruda 6X HPUS</td><td>oral pain, irritability</td></tr><tr><td>Ferrum Phosphoricum 12X HPUS</td><td>oral discomfort, swelling gums</td></tr><tr><td>Magnesia Phosphorica 12X HPUS</td><td>oral pain, occasional sleeplessness</td></tr><tr><td>Silicea 12X HPUS</td><td>oral pain at night, occasional sleeplessness</td></tr></tbody></table>"],"stop_use":["Stop use and ask a doctor if ■ symptoms persist for more than 72 hours or worsen. ■ swelling increases; nasal congestion, rash or fever is present or develops. ■ irritation, pain or redness persists or worsens."],"version":"13","warnings":["Warnings Stop use and ask a doctor if ■ symptoms persist for more than 72 hours or worsen. ■ swelling increases; nasal congestion, rash or fever is present or develops. ■ irritation, pain or redness persists or worsens. Keep out of reach of children"]}