{"adverse_reactions":["6. ADVERSE REACTIONS 6.1. None known (see CONTRAINDICATIONS for hypersensitivity information)."],"clinical_pharmacology":["12. CLINICAL PHARMACOLOGY 12.1. GUNA-DIUR exerts a diuretic effect. This is based on homeopthica Materia Medica and homeopathic principles. 12.2. Pharmacodynamics Not applicable to homeopthic medicinal products. 12.3. Pharmacokinetics Not applicable to homeopthic medicinal products."],"clinical_studies":["14. CLINICAL STUDIES 14.1. GUNA-DIUR efficacy is not supported by clinical studies. It is based on homeopathic Materia Medica and scientific literature."],"contraindications":["4. CONTRAINDICATIONS 4.1. There is no history of hypersensitivity to GUNA-DIUR. However, do not use if you are hypersensitive to any of the active ingredients of Guna-Diur."],"description":["11. DESCRIPTION 11. 1 GUNA-DIUR is a homeopathic medicine indicated for the temporary relief of fluid retention, tissue swelling and related disconforts."],"dosage_and_administration":["2. DOSAGE AND ADMINISTRATION Adults: 20 drops in a little water, 2 times per day for an avarage of two months. Stop use and ask a doctor if symptoms persist more than 5 days. Administration may very according to individual needs. GUNA-DIUR may be used together with other homeopthic medicines."],"dosage_forms_and_strengths":["3. DOSAGE FORMS AND STRENGTHS 3.1. 30 ml Bottle dropper container contains: Active ingredients: Amiloride 4X 0.006 ml, Apis Mellifica 2X 0.626 ml, Berberis Vulgaris T 0.314 ml, Hydrochlorothiazide 4X 0.006 ml, Hypophysis 12X 6.314 ml, Mouse-Ear Hawkweed T 6.314 ml, Solidago Virgaurea T 0.314 ml, Spironolactone 4X 0.006 ml. Inactive Ingredient: Ethylic Alcohol 30%"],"drug_abuse_and_dependence":["9. DRUG ABUSE AND DEPENDENCE 9.1. No Known."],"drug_interactions":["7. DRUG INTERACTIONS 7.1. None Known"],"effective_time":"20181221","id":"7e7c2115-72fe-9ca5-e053-2a91aa0ae101","indications_and_usage":["1. INDICATIONS AND USAGE 1.1 Temporary relief of fluid retention 1.2 Tissue swelling and related disconforts"],"information_for_patients":["17. PATIENT COUNSELING INFORMATION 17.1. Patients should be informed about Homeopathy and the main differences with conventional clinical approaches."],"nonclinical_toxicology":["13. NONCLINICAL TOXICOLOGY 13.1. Not available."],"openfda":{"brand_name":["GUNA-DIUR"],"generic_name":["AMILORIDE - APIS MELLIFERA - BERBERIS VULGARIS FRUIT - HIERACIUM PILOSELLA FLOWERING TOP - HYDROCHLOROTHIAZIDE - SOLIDAGO VIRGAUREA FLOWERING TOP - SPIRONOLACTONE - SUS SCROFA PITUITARY GLAND -"],"is_original_packager":[true],"manufacturer_name":["Guna spa"],"nui":["N0000008859","N0000175359","N0000175418","N0000185021","N0000175629","N0000184306","N0000185001","M0000728","M0002274","N0000175419","M0471776","N0000175557","N0000011310"],"package_ndc":["17089-260-18"],"pharm_class_cs":["Allergens [CS]","Bee Venoms [CS]","Thiazides [CS]"],"pharm_class_epc":["Potassium-sparing Diuretic [EPC]","Standardized Insect Venom Allergenic Extract [EPC]","Thiazide Diuretic [EPC]","Aldosterone Antagonist [EPC]"],"pharm_class_moa":["Aldosterone Antagonists [MoA]"],"pharm_class_pe":["Decreased Renal K+ Excretion [PE]","Increased Diuresis [PE]","Increased Histamine Release [PE]","Cell-mediated Immunity [PE]","Increased IgG Production [PE]"],"product_ndc":["17089-260"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"spl_id":["7e7c2115-72fe-9ca5-e053-2a91aa0ae101"],"spl_set_id":["3f91cd92-eb6d-4bda-9cad-2e11e0b0fbe2"],"substance_name":["AMILORIDE","APIS MELLIFERA","BERBERIS VULGARIS FRUIT","HYDROCHLOROTHIAZIDE","SUS SCROFA PITUITARY GLAND","HIERACIUM PILOSELLA FLOWERING TOP","SOLIDAGO VIRGAUREA FLOWERING TOP","SPIRONOLACTONE"],"unii":["7DZO8EB0Z3","7S82P3R43Z","6XEF22AHC3","0J48LPH2TH","L0PFEMQ1DT","08A7Y81S1P","5405K23S50","27O7W4T232"]},"overdosage":["10. OVERDOSAGE 10.1. No Known."],"package_label_principal_display_panel":["PACKAGE LABEL 5USPIL-GUNA-DIUR-rev05-10-18"],"references":["15. REFERENCES 15.1. H.H. Reckeweg. Homeopathic Materia Medica. Aurelia Verlag. 15.2. Boericke, William, Materia Medica with Reperatory, 1927, ninth edition"],"set_id":"3f91cd92-eb6d-4bda-9cad-2e11e0b0fbe2","spl_product_data_elements":["GUNA-DIUR amiloride - apis mellifera - berberis vulgaris fruit - hieracium pilosella flowering top - hydrochlorothiazide - solidago virgaurea flowering top - spironolactone - sus scrofa pituitary gland - ALCOHOL AMILORIDE AMILORIDE APIS MELLIFERA APIS MELLIFERA BERBERIS VULGARIS FRUIT BERBERIS VULGARIS FRUIT HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE SUS SCROFA PITUITARY GLAND SUS SCROFA PITUITARY GLAND HIERACIUM PILOSELLA FLOWERING TOP HIERACIUM PILOSELLA FLOWERING TOP SOLIDAGO VIRGAUREA FLOWERING TOP SOLIDAGO VIRGAUREA FLOWERING TOP SPIRONOLACTONE SPIRONOLACTONE"],"storage_and_handling":["16. HOW SUPPLIED/STORAGE AND HANDLING 16.1. NDC 17089-260-18 Oral Solution/Drops 30 mL 16.2. Store at 20-25°C (68-77° F). Excursions permitted between 15°-30°C (59°-86°F)."],"use_in_specific_populations":["8. USE IN SPECIFIC POPULATIONS 8.1. Pregnancy : Pregnancy category C. Animal reproduction studies have not been conducted with GUNA-DIUR. GUNA®- DIUR should not be given to a pregnant woman. 8.2. Lactation : It is not known whether any of the ingredients in GUNA- DIUR are secreted in human milk. However, since many drugs are secreted in human milk, caution should be exercised when GUNA- DIUR is administered to a nursing woman. 8.3. Pediatric use: Safety and effectiveness in pediatric patients have not been established. 8.4. Geriatric use : No restrictions."],"version":"2","warnings_and_cautions":["5. WARNINGS AND PRECAUTIONS 5.1. GUNA-DIUR is contraindicated in patients with anuria and in patients with a history of hypersensitivity to Spironolactone, Amiloride, or Hydrocholorthiazide. 5.2. Use with caution in patients taking diuretic medications. 5.3 Keep out of reach of children."]}