{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-01", "results": { "skip": 0, "limit": 1, "total": 11 } }, "results": [ { "spl_product_data_elements": [ "GUNA-AWARENESS BETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN - ALCOHOL GOLD GOLD BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN BUFO BUFO CUTANEOUS GLAND BUFO BUFO CUTANEOUS GLAND CALCIUM CARBONATE CALCIUM CATION CHROMIC SULFATE CHROMIC CATION CICUTA VIROSA ROOT CICUTA VIROSA ROOT COBALAMIN COBALAMIN UBIDECARENONE UBIDECARENONE COPPER COPPER IRON IRON FOLIC ACID FOLIC ACID SUS SCROFA FRONTAL LOBE SUS SCROFA FRONTAL LOBE LACHESIS MUTA VENOM LACHESIS MUTA VENOM MELATONIN MELATONIN MOLYBDENUM MOLYBDENUM NEUROTROPHIN-3 NEUROTROPHIN-3 NEUROTROPHIN-4 NEUROTROPHIN-4 OXYTOCIN OXYTOCIN SILICON DIOXIDE SILICON DIOXIDE SUS SCROFA TEMPORAL LOBE SUS SCROFA TEMPORAL LOBE THYROTROPIN ALFA THYROTROPIN ALFA BETAINE BETAINE VANADIUM VANADIUM ZINC ZINC" ], "active_ingredient": [ "ACTIVE INGREDIENTS/PURPOSE AURUM METALLICUM 12X ANTIDEPRESSANT BRAIN DERIVED NEUROTROPHIC FACTOR 4C HELPS MENTAL ACTIVITY BUFO RANA 12X HELPS MENTAL ACTIVITY CALCAREA CARBONICA 3X IMMUNE STRENGTHENING CHROMIUM SULPHURICUM 3X DETOXIFICATION CICUTA VIROSA 12X ANTISPASTIC COBALAMIN 3X ANTIOXIDANT COENZYME Q 3X ANTIOXIDANT CUPRUM METALLICUM 12X ANTISPASTIC FERRUM METALLICUM 3X ANTIOXIDANT FOLIC ACID 3X ANTIOXIDANT FRONTAL LOBE 6X SUPPORTS COORDINATING BEHAVIOR LACHESIS MUTUS 12X ANTI-INFLAMMATORY MELATONIN 4C ANTISTRESS MOLYBDENUM METALLICUM 3X ANTIAGING NEUROTROPHIN 3 4C SUPPORTS MENTAL ACTIVITY NEUROTROPHIN 4 4C SUPPORTS MENTAL ACTIVITY OXYTOCIN 6X STIMULATES ADRENAL CORTEX SILICEA 12X IMMUNE STRENGTHENING TEMPORAL LOBE 6X SUPPORTS AUDITORY PROCESSING THYROTROPIN-RELEASING HORMONE 3X HELPS MENTAL ACTIVITY TRIMETHYLGLYCINE 3X DETOXIFICATION VANADIUM METALLICUM 6X ANTIOXIDANT ZINCUM METALLICUM 3X ANTISTRESS" ], "purpose": [ "USES Temporary relief of symptoms related to: Difficulty concentrating Difficulty falling asleep Irritability" ], "warnings": [ "WARNINGS Stop use and ask doctor if symptoms persist more than 5 days or worsen. If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away. Contains ethyl alcohol 30%" ], "pregnancy_or_breast_feeding": [ "PREGNANCY If pregnant or breast-feeding ask a doctor before use" ], "keep_out_of_reach_of_children": [ "WARNINGS Keep out of reach of children" ], "dosage_and_administration": [ "DIRECTIONS Take 15 minutes before meals Adults and children 12 years and older 20 drops in a little water, 2 times per day Children between 12 years and 6 years of age 10 drops in a little water, 2 times per day Children under 6 years 5 drops in a glass of water, 2 times per day" ], "questions": [ "QUESTIONS Questions?: info@gunainc.com, tel. (484) 223-3500" ], "indications_and_usage": [ "Take 15 minutes before meals" ], "inactive_ingredient": [ "Inactive ingredient : Ethyl alcohol 30%." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL 5USAWA GUNA AWARENESS-Rev04-24-05-18" ], "set_id": "10e46b39-7903-4390-b72d-865291245b4c", "id": "ed80e4f1-5ff1-5d2f-e053-2995a90afc23", "effective_time": "20221115", "version": "5", "openfda": { "brand_name": [ "GUNA-AWARENESS" ], "generic_name": [ "BETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN -" ], "manufacturer_name": [ "Guna spa" ], "product_ndc": [ "17089-350" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BETAINE", "BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN", "BUFO BUFO CUTANEOUS GLAND", "CALCIUM CARBONATE", "CHROMIC SULFATE", "CICUTA VIROSA ROOT", "COBALAMIN", "COPPER", "FOLIC ACID", "GOLD", "IRON", "LACHESIS MUTA VENOM", "MELATONIN", "MOLYBDENUM", "NEUROTROPHIN-3", "NEUROTROPHIN-4", "OXYTOCIN", "SILICON DIOXIDE", "SUS SCROFA FRONTAL LOBE", "SUS SCROFA TEMPORAL LOBE", "THYROTROPIN ALFA", "UBIDECARENONE", "VANADIUM", "ZINC" ], "spl_id": [ "ed80e4f1-5ff1-5d2f-e053-2995a90afc23" ], "spl_set_id": [ "10e46b39-7903-4390-b72d-865291245b4c" ], "package_ndc": [ "17089-350-18" ], "is_original_packager": [ true ], "upc": [ "0317089350187" ], "nui": [ "N0000175804", "N0000175805", "M0005152", "N0000175831", "N0000008595", "N0000008924", "N0000175830", "N0000185508", "N0000175629", "N0000184306", "M0000728", "N0000009705", "N0000175828", "M0015703", "N0000175949", "M0021496" ], "pharm_class_moa": [ "Methylating Activity [MoA]" ], "pharm_class_epc": [ "Methylating Agent [EPC]", "Copper-containing Intrauterine Device [EPC]", "Standardized Chemical Allergen [EPC]", "Oxytocic [EPC]", "Thyroid Stimulating Hormone [EPC]" ], "pharm_class_cs": [ "Copper [CS]", "Allergens [CS]", "Oxytocin [CS]", "Thyrotropin [CS]" ], "pharm_class_pe": [ "Decreased Embryonic Implantation [PE]", "Decreased Sperm Motility [PE]", "Inhibit Ovum Fertilization [PE]", "Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased Uterine Smooth Muscle Contraction or Tone [PE]" ], "unii": [ "3SCV180C9W", "A1ED6W905I", "Q59QU6N72Q", "H0G9379FGK", "Y0C99N5TMZ", "YEA9P21S8N", "8406EY2OQA", "789U1901C5", "935E97BOY8", "79Y1949PYO", "E1UOL152H7", "VSW71SS07I", "JL5DK93RCL", "81AH48963U", "02R4V6T25Y", "P658DCA9XD", "1JQS135EYN", "ETJ7Z6XBU4", "GV54Q19G55", "490XI1KB4S", "AVX3D5A4LM", "EJ27X76M46", "00J9J9XKDE", "J41CSQ7QDS" ] } } ] }