{"id":"sodium-sulfate","_fda":{"id":"28fb3178-9aac-406f-a82a-de53d0876f67","set_id":"11cad8ba-6914-420e-bab0-4ca37d33f2e6","openfda":{"unii":["Q40Q9N063P","2P3VWU3H10","6T6CO7R3Z5","W9FZA51AS1","56K0VVT47P","S003A158SB","01G9XEA93N","79N6542N18","C88X29Y479","E4GA8884NN","I76KB35JEV","ETJ7Z6XBU4","0YPR65R21J","O642E96711","91D9GV0Z28","900961Z8VR"],"route":["ORAL"],"spl_id":["28fb3178-9aac-406f-a82a-de53d0876f67"],"brand_name":["BHI Migraine"],"spl_set_id":["11cad8ba-6914-420e-bab0-4ca37d33f2e6"],"package_ndc":["62795-1019-3"],"product_ndc":["62795-1019"],"generic_name":["ACETIC ACID, ARANEUS DIADEMATUS, ASAFETIDA, BRYONIA ALBA WHOLE, TRIBASIC CALCIUM PHOSPHATE, ACTIVATED CHARCOAL, CINCHONA OFFICINALIS BARK, MARSDENIA CONDURANGO BARK, TUBOCURARINE CHLORIDE, KALMIA LATIFOLIA LEAF, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, PHOSPHORIC ACID, PULSATILLA VULGARIS, CLAVICEPS PURPUREA SCLEROTIUM, AND SILICON DIOXIDE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["ACETIC ACID","ACTIVATED CHARCOAL","ARANEUS DIADEMATUS","ASAFETIDA","BRYONIA ALBA WHOLE","CINCHONA OFFICINALIS BARK","CLAVICEPS PURPUREA SCLEROTIUM","KALMIA LATIFOLIA LEAF","LYCOPODIUM CLAVATUM SPORE","MARSDENIA CONDURANGO BARK","PHOSPHORIC ACID","PULSATILLA VULGARIS","SILICON DIOXIDE","SODIUM SULFATE","STRYCHNINE NITRATE","TRIBASIC CALCIUM PHOSPHATE","TUBOCURARINE CHLORIDE"],"manufacturer_name":["MediNatura Inc"],"is_original_packager":[true]},"purpose":["PURPOSE Migraine Relief Tablets Relieves: • Headache Pain • Headache Pain with Nausea • Neck Muscle Tension"],"version":"5","warnings":["WARNINGS If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If symptoms persist or worsen, a health professional should be consulted. Ask a doctor before use if you have never had migraines diagnosed by a health professional, you have a headache that is different from your usual migraines, you have the worst headache of your life, you have fever and stiff neck, you have a migraine so severe as to require bed rest. Do not use if known sensitivity to BHI Migraine or any of its ingredients exists."],"effective_time":"20230928","active_ingredient":["INGREDIENT SECTIONS Each tablet contains: Aceticum acidum 6X, *Aranea diadema 8X, *Asafoetida 6X, *Bryonia alba 30X, Calcarea phosphorica 10X, *Carbo vegetabilis 10X, *Cinchona officinalis 4X, *Condurango 4X, *Curare 10X, *Kalmia latifolia 8X, *Lycopodium clavatum 6X, Natrum sulphuricum 6X, Phosphoricum acidum 6X, *Pulsatilla 4X, *Secale cornutum 6X, *Silicea 10X, Strychninum nitricum 8X 17.6 mg each. *Natural Ingredients"],"inactive_ingredient":["INACTIVE INGREDIENTS Inactive Ingredients: Dextrose, Magnesium Stearate, Maltodextrin"],"indications_and_usage":["USES For the temporary relief of minor migraine headache pain, headache pain with nausea, headache due to simple nervous tension"],"dosage_and_administration":["DIRECTIONS At first sign of symptoms: Adults: 1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage. Standard dosage: Adults: Take 1-2 tablets every 4 to 6 hours. Do not exceed 12 tablets in 24 hours. For children under 18, consult your health professional. Allow tablets to dissolve completely in the mouth, do not swallow."],"spl_product_data_elements":["BHI Migraine ACETIC ACID, ARANEUS DIADEMATUS, ASAFETIDA, BRYONIA ALBA WHOLE, TRIBASIC CALCIUM PHOSPHATE, ACTIVATED CHARCOAL, CINCHONA OFFICINALIS BARK, MARSDENIA CONDURANGO BARK, TUBOCURARINE CHLORIDE, KALMIA LATIFOLIA LEAF, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, PHOSPHORIC ACID, PULSATILLA VULGARIS, CLAVICEPS PURPUREA SCLEROTIUM, and SILICON DIOXIDE ACETIC ACID ACETIC ACID ARANEUS DIADEMATUS ARANEUS DIADEMATUS ASAFETIDA ASAFETIDA BRYONIA ALBA WHOLE BRYONIA ALBA WHOLE TRIBASIC CALCIUM PHOSPHATE CALCIUM CATION ACTIVATED CHARCOAL ACTIVATED CHARCOAL CINCHONA OFFICINALIS BARK CINCHONA OFFICINALIS BARK MARSDENIA CONDURANGO BARK MARSDENIA CONDURANGO BARK TUBOCURARINE CHLORIDE TUBOCURARINE KALMIA LATIFOLIA LEAF KALMIA LATIFOLIA LEAF LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE SODIUM SULFATE SODIUM SULFATE ANHYDROUS PHOSPHORIC ACID PHOSPHORIC ACID PULSATILLA VULGARIS PULSATILLA VULGARIS CLAVICEPS PURPUREA SCLEROTIUM CLAVICEPS PURPUREA SCLEROTIUM SILICON DIOXIDE SILICON DIOXIDE STRYCHNINE NITRATE STRYCHNINE MAGNESIUM STEARATE MALTODEXTRIN DEXTROSE Leafman"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN Keep out of reach of children."],"package_label_principal_display_panel":["Add image transcription here... BHI Migraine Tablet.jpg"]},"safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"3320 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"2360 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"978 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"851 reports"},{"date":"","signal":"ABDOMINAL PAIN","source":"FDA FAERS","actionTaken":"748 reports"},{"date":"","signal":"ABDOMINAL DISTENSION","source":"FDA FAERS","actionTaken":"718 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"609 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"577 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"485 reports"},{"date":"","signal":"ABDOMINAL PAIN UPPER","source":"FDA FAERS","actionTaken":"466 reports"}]},"_chembl":null,"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=SODIUM SULFATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:56:50.589373+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:56:57.610063+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T03:56:49.198265+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SODIUM SULFATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:56:59.114147+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:56:47.701779+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:57:12.565231+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:56:47.701819+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T03:57:01.258592+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL233406/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:57:00.119149+00:00"}},"_dailymed":{"setId":"f650dd78-615c-42d3-9b2d-3a989039d80c","title":"UROGESIC BLUE (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.]"},"_scrapedAt":"2026-03-27T23:37:55.685Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T03:57:12.843990+00:00","fieldsConflicting":0,"overallConfidence":0.95},"indications":{"approved":[{"id":"sodium-sulfate-migraine-headache-pain","name":"Migraine headache pain","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Not specified","pivotalTrial":null,"restrictions":[],"patientPopulation":"Not specified","diagnosticRequired":null,"brandNameForIndication":""},{"id":"sodium-sulfate-headache-pain-with-nausea","name":"Headache pain with nausea","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Not specified","pivotalTrial":null,"restrictions":[],"patientPopulation":"Not specified","diagnosticRequired":null,"brandNameForIndication":""},{"id":"sodium-sulfate-headache-due-to-simple-nervous","name":"Headache due to simple nervous tension","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Not specified","pivotalTrial":null,"restrictions":[],"patientPopulation":"Not specified","diagnosticRequired":null,"brandNameForIndication":""}]},"trialDetails":[{"nctId":"NCT07271381","phase":"NA","title":"THREAT: Testing Harms Related to Exposure to Allergenic and Epithelial Toxins","status":"RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2026-04-01","conditions":"Allergic, Inflammatory","enrollment":120},{"nctId":"NCT04530565","phase":"PHASE3","title":"Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2021-01-25","conditions":"B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); 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