{"active_ingredient":["Active ingredients Active ingredients Purpose Aconitum Napellus 6X HPUS backache pain Arnica Montana 6X HPUS backache pain Bellis Perennis 6X HPUS backache pain Bryonia Alba 6X HPUS backache pain Magnesia Phosphorica 6X HPUS backache pain Rhus Toxicodendron 6X HPUS backache pain \"HPUS\" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States."],"active_ingredient_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><paragraph><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients</content></content></paragraph></td><td><paragraph><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></paragraph></td></tr><tr><td><paragraph>Aconitum Napellus 6X HPUS</paragraph></td><td><paragraph>backache pain</paragraph></td></tr><tr><td><paragraph>Arnica Montana 6X HPUS</paragraph></td><td><paragraph>backache pain</paragraph></td></tr><tr><td><paragraph>Bellis Perennis 6X HPUS</paragraph></td><td>backache pain</td></tr><tr><td><paragraph>Bryonia Alba 6X HPUS</paragraph></td><td>backache pain</td></tr><tr><td><paragraph>Magnesia Phosphorica 6X HPUS</paragraph></td><td>backache pain</td></tr><tr><td><paragraph>Rhus Toxicodendron 6X HPUS</paragraph></td><td>backache pain</td></tr></tbody></table>"],"dosage_and_administration":["Directions ■ Use as directed. Adults and children 12 years and over At onset of symptoms, dissolve 2 tablets under tongue every 15 minutes up to 4 doses. If symptoms persist, 2 tablets every 4 hours until relieved. Children under 12 years of age Ask a doctor before use."],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>Adults and children   12 years and over </td><td><paragraph>At onset of symptoms, dissolve 2 tablets under tongue every</paragraph><paragraph>15 minutes up to 4 doses. If symptoms persist, 2 tablets every</paragraph><paragraph>4 hours until relieved.</paragraph></td></tr><tr><td>Children under   12 years of age </td><td>Ask a doctor before use.</td></tr></tbody></table>"],"effective_time":"20230510","id":"fb5962be-5af1-206f-e053-6294a90aa8b0","inactive_ingredient":["Inactive ingredients Acacia Gum, Lactose."],"indications_and_usage":["Uses ■ Temporarily relieves backache pain"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"brand_name":["Backache Relief"],"generic_name":["ACONITUM NAPELLUS, BRYONIA ALBA ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, BELLIS PERENNIS, TOXICODENDRON PUBESCENS LEAF AND ARNICA MONTANA"],"is_original_packager":[true],"manufacturer_name":["Hyland's Inc."],"package_ndc":["54973-4011-1"],"product_ndc":["54973-4011"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["fb5962be-5af1-206f-e053-6294a90aa8b0"],"spl_set_id":["a51452b3-0aba-6928-e053-2995a90a1619"],"substance_name":["ARNICA MONTANA","BELLIS PERENNIS","ACONITUM NAPELLUS","BRYONIA ALBA ROOT","MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE","TOXICODENDRON PUBESCENS LEAF"],"unii":["O80TY208ZW","2HU33I03UY","U0NQ8555JD","T7J046YI2B","HF539G9L3Q","6IO182RP7A"]},"other_safety_information":["DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING."],"package_label_principal_display_panel":["Principal Display Panel NDC 54973-4011-1 100 TABLETS label carton"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding Ask a health professional before use."],"purpose":["Backache Relief"],"questions":["Questions? www.hylands.com or care@hylands.com"],"recent_major_changes":["Dosage and Administration (Directions) ■ Use as directed Adults and children 12 years and over At onset of symptoms, dissolve 2 tablets under tongue every 15 minutes up to 4 doses. If symptoms persist, 2 tablets every 4 hours until relieved. Children under 12 years of age Ask a doctor before use.","Indications and Usage Uses ■ Helps temporarily relieve backache pain Removed \"Helps\""],"recent_major_changes_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>Adults and children    12 years and over </td><td>At onset of symptoms, dissolve 2 tablets under tongue every    15 minutes up to 4 doses. If symptoms persist, 2 tablets every    4 hours until relieved. </td></tr><tr><td>Children under    12 years of age </td><td>Ask a doctor before use.</td></tr></tbody></table>"],"set_id":"a51452b3-0aba-6928-e053-2995a90a1619","spl_product_data_elements":["Backache Relief Aconitum Napellus, Bryonia Alba Root, Magnesium Phosphate, Dibasic Trihydrate, Bellis Perennis, Toxicodendron Pubescens Leaf and Arnica Montana LACTOSE MONOHYDRATE ACACIA ARNICA MONTANA ARNICA MONTANA BELLIS PERENNIS BELLIS PERENNIS ACONITUM NAPELLUS ACONITUM NAPELLUS BRYONIA ALBA ROOT BRYONIA ALBA ROOT MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE MAGNESIUM CATION TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF White to Off white"],"spl_unclassified_section":["Drug Facts Active ingredients Active ingredients Purpose Aconitum Napellus 6X HPUS backache pain Arnica Montana 6X HPUS backache pain Bellis Perennis 6X HPUS backache pain Bryonia Alba 6X HPUS backache pain Magnesia Phosphorica 6X HPUS backache pain Rhus Toxicodendron 6X HPUS backache pain \"HPUS\" indicates that the active ingredients are in the official 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><paragraph><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients</content></content></paragraph></td><td><paragraph><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></paragraph></td></tr><tr><td><paragraph>Aconitum Napellus 6X HPUS</paragraph></td><td><paragraph>backache pain</paragraph></td></tr><tr><td><paragraph>Arnica Montana 6X HPUS</paragraph></td><td><paragraph>backache pain</paragraph></td></tr><tr><td><paragraph>Bellis Perennis 6X HPUS</paragraph></td><td>backache pain</td></tr><tr><td><paragraph>Bryonia Alba 6X HPUS</paragraph></td><td>backache pain</td></tr><tr><td><paragraph>Magnesia Phosphorica 6X HPUS</paragraph></td><td>backache pain</td></tr><tr><td><paragraph>Rhus Toxicodendron 6X HPUS</paragraph></td><td>backache pain</td></tr></tbody></table>"],"stop_use":["Stop use and ask a doctor if ■ pain gets worse or lasts more than 7 days. ■ new symptoms occur. ■ redness or swelling is present"],"version":"4","warnings":["Warnings Stop use and ask a doctor if ■ pain gets worse or lasts more than 7 days. ■ new symptoms occur. ■ redness or swelling is present If pregnant or breastfeeding Ask a health professional before use. Keep out of reach of children."]}