{"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 \"HPUS\" is the Homeopathic Pharmacopoeia of the United States."],"active_ingredient_table":["
Active ingredientsPurpose
Arnica Montana 30X HPUSsore, sensitive or swelling gums
Calcarea Carbonica 12X HPUSteething, sore, sensitive or swelling gums
Calcarea Phosphorica 12X HPUSteething, sensitive, swelling gums, oral pain
Chamomilla 12X HPUSsore, sensitive or swelling gums
Coffea Cruda 6X HPUSoral pain, irritability
Ferrum Phosphoricum 12X HPUSoral discomfort, swelling gums
"],"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. If symptoms persist, 2 tablets every 4 hours until relieved. Children 6 months to under 3 years At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved."],"dosage_and_administration_table":["
Children under 6 monthsAt onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved.
Children 6 months to under 3 years At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.
"],"effective_time":"20250206","id":"2d83ba02-987c-b74b-e063-6294a90a6dc0","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"],"keep_out_of_reach_of_children":["Keep out of reach of children"],"openfda":{"brand_name":["Baby Oral Pain Relief"],"generic_name":["OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, ARABICA COFFEE BEAN, ARNICA MONTANA, FERRUM PHOSPHORICUM AND MATRICARIA CHAMOMILLA"],"is_original_packager":[true],"manufacturer_name":["Hyland' Inc."],"nui":["N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0006342","M0016962","M0516536"],"package_ndc":["54973-3315-1","54973-3315-3","54973-3315-7"],"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":["54973-3315"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["2d83ba02-987c-b74b-e063-6294a90a6dc0"],"spl_set_id":["5904f126-e8f0-a892-e053-2991aa0aef0f"],"substance_name":["OYSTER SHELL CALCIUM CARBONATE, CRUDE","TRIBASIC CALCIUM PHOSPHATE","ARABICA COFFEE BEAN","ARNICA MONTANA","MATRICARIA CHAMOMILLA","FERRUM PHOSPHORICUM"],"unii":["2E32821G6I","91D9GV0Z28","3SW678MX72","O80TY208ZW","G0R4UBI2ZZ","91GQH8I5F7"]},"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* DAYTIME NO BENZOCAINE, DYES or PARABENS Teething Pain Oral Discomfort Irritability Swelling 0+ MONTHS 125 QUICK-DISSOLVING TABLETS HOMEOPATHIC BOPR0000T125CTNH1"],"purpose":["Helps temporarily relieve symptoms of oral pain or discomfort in children, including: teething, gum sensitivity, swelling or soreness of gums, irritability"],"questions":["Questions? www.hylands.com or care@hylands.com"],"recent_major_changes":["Indications and Usage Uses* Removed *"],"set_id":"5904f126-e8f0-a892-e053-2991aa0aef0f","spl_product_data_elements":["Baby Oral Pain Relief oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla ACACIA LACTOSE MONOHYDRATE ANHYDROUS LACTOSE OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE TRIBASIC CALCIUM PHOSPHATE PHOSPHATE ION ARABICA COFFEE BEAN ARABICA COFFEE BEAN ARNICA MONTANA ARNICA MONTANA MATRICARIA CHAMOMILLA MATRICARIA CHAMOMILLA FERRUM PHOSPHORICUM FERRUM PHOSPHORICUM"],"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 \"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":["
Active ingredientsPurpose
Arnica Montana 30X HPUSsore, sensitive or swelling gums
Calcarea Carbonica 12X HPUSteething, sore, sensitive or swelling gums
Calcarea Phosphorica 12X HPUSteething, sensitive, swelling gums, oral pain
Chamomilla 12X HPUSsore, sensitive or swelling gums
Coffea Cruda 6X HPUSoral pain, irritability
Ferrum Phosphoricum 12X HPUSoral discomfort, swelling gums
"],"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":"15","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"]}