{ "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": "2026-06-09", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "spl_product_data_elements": [ "GUNA-DIGEST angelica archangelica root - anisum - artemisia abrotanum flowering top - ascorbic acid - citrullus colocynthis fruit pulp - gentiana lutea root - melatonin - niacin - pancrelipase amylase - pancrelipase lipase - pork liver - serotonin - strychnos nux-vomica seed - sus scrofa diencephalon - sus scrofa duodenum - sus scrofa gall bladder - sus scrofa pancreas - sus scrofa pylorus - thiamine hydrochloride - trypsin - tryptophan - ALCOHOL ARTEMISIA ABROTANUM FLOWERING TOP ARTEMISIA ABROTANUM FLOWERING TOP PANCRELIPASE AMYLASE PANCRELIPASE AMYLASE ANGELICA ARCHANGELICA ROOT ANGELICA ARCHANGELICA ROOT ANISUM ANISUM ASCORBIC ACID ASCORBIC ACID CITRULLUS COLOCYNTHIS FRUIT PULP CITRULLUS COLOCYNTHIS FRUIT PULP SUS SCROFA DIENCEPHALON SUS SCROFA DIENCEPHALON SUS SCROFA DUODENUM SUS SCROFA DUODENUM SUS SCROFA GALLBLADDER SUS SCROFA GALLBLADDER GENTIANA LUTEA ROOT GENTIANA LUTEA ROOT PORK LIVER PORK LIVER PANCRELIPASE LIPASE PANCRELIPASE LIPASE MELATONIN MELATONIN NIACIN NIACIN STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED SUS SCROFA PANCREAS SUS SCROFA PANCREAS SUS SCROFA PYLORUS SUS SCROFA PYLORUS SEROTONIN SEROTONIN THIAMINE HYDROCHLORIDE THIAMINE ION TRYPTOPHAN TRYPTOPHAN TRYPSIN TRYPSIN" ], "active_ingredient": [ "ACTIVE INGREDIENTS/PURPOSE ABROTANUM 1X INTESTINAL ACTIVITY SUPPORT AMYLASE PANCREATIC 2X DIGESTIVE ENZYME ANGELICA ARCHANGELICA 1X DIFFICULTY DIGESTING DUE TO STRESS ANISUM 1X ANTIFLATULANCE ASCORBIC ACID 2X METABOLIC SUPPORT COLOCYNTHIS 3X 10X 30X 200X NERVOUS IRRITATION DIENCEPHALON 3X 6X 12X REGULATES DIGESTIVE ACTIVITY DUODENUM 6X 8X 12X BOWEL ACTIVITY SUPPORT GALL BLADDER 6X 8X 12X HELPS BILE RELEASE GENTIANA LUTEA 1X DIGESTIVE DISORDERS HEPAR 6X 8X 12X HELPS DIGESTIVE ACTIVITY LIPASE ENZYME 2X DIGESTIVE ENZYME MELATONIN 4C HORMONAL CONTROL NIACIN 2X METABOLIC SUPPORT NUX VOMICA 3X 10X 15X 30X 200X 1000X DIGESTIVE DISORDERS PANCREAS 6X 8X 12X HELPS DIGESTIVE ENZYMES SECRETION PYLORUS 6X 8X 12X FUNCTIONAL DIGESTIVE SUPPORT SEROTONIN 6X HORMONAL SUPPORT THIAMINUM HYDROCHLORICUM 4X METABOLIC SUPPORT TRYPSIN 2X DIGESTIVE ENZYME TRYPTOPHAN 6X HORMONAL SUPPORT" ], "purpose": [ "USES Temporary relief of indigestion symptoms such as: Drowsiness Nausea Constipation" ], "warnings": [ "WARNINGS Stop use and ask doctor if symptoms persist more than 5 days or worsen. I f 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 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" ], "inactive_ingredient": [ "Inactive ingredient : Ethyl alcohol 30%" ], "indications_and_usage": [ "Take 15 minutes before meals." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL 5USDIG-GUNA-DIGEST-100718-rev6" ], "set_id": "624228b9-70be-43a1-93a5-f6e708814fa2", "id": "7d9b872d-b3be-64a9-e053-2991aa0a7808", "effective_time": "20181222", "version": "3", "openfda": { "brand_name": [ "GUNA-DIGEST" ], "generic_name": [ "ANGELICA ARCHANGELICA ROOT - ANISUM - ARTEMISIA ABROTANUM FLOWERING TOP - ASCORBIC ACID - CITRULLUS COLOCYNTHIS FRUIT PULP - GENTIANA LUTEA ROOT - MELATONIN - NIACIN - PANCRELIPASE AMYLASE - PANCRELIPASE LIPASE - PORK LIVER - SEROTONIN - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA DIENCEPHALON - SUS SCROFA DUODENUM - SUS SCROFA GALL BLADDER - SUS SCROFA PANCREAS - SUS SCROFA PYLORUS - THIAMINE HYDROCHLORIDE - TRYPSIN - TRYPTOPHAN -" ], "manufacturer_name": [ "Guna spa" ], "product_ndc": [ "17089-301" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ANGELICA ARCHANGELICA ROOT", "ANISUM", "ARTEMISIA ABROTANUM FLOWERING TOP", "ASCORBIC ACID", "CITRULLUS COLOCYNTHIS FRUIT PULP", "GENTIANA LUTEA ROOT", "MELATONIN", "NIACIN", "PANCRELIPASE AMYLASE", "PANCRELIPASE LIPASE", "PORK LIVER", "SEROTONIN", "STRYCHNOS NUX-VOMICA SEED", "SUS SCROFA DIENCEPHALON", "SUS SCROFA DUODENUM", "SUS SCROFA GALLBLADDER", "SUS SCROFA PANCREAS", "SUS SCROFA PYLORUS", "THIAMINE HYDROCHLORIDE", "TRYPSIN", "TRYPTOPHAN" ], "spl_id": [ "7d9b872d-b3be-64a9-e053-2991aa0a7808" ], "spl_set_id": [ "624228b9-70be-43a1-93a5-f6e708814fa2" ], "package_ndc": [ "17089-301-18" ], "is_original_packager": [ true ], "upc": [ "0317089301189" ], "nui": [ "N0000193618", "M0001797", "N0000175594", "M0014839", "N0000185375", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0016962", "M0516536" ], "pharm_class_epc": [ "Vitamin C [EPC]", "Nicotinic Acid [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]" ], "pharm_class_cs": [ "Ascorbic Acid [CS]", "Nicotinic Acids [CS]", "Allergens [CS]", "Plant Proteins [CS]", "Seed Storage Proteins [CS]" ], "pharm_class_pe": [ "Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]" ], "unii": [ "DTN01M69SN", "21C2F5E8RE", "QG07G580U0", "PQ6CK8PD0R", "23H32AOH17", "S72O3284MS", "JL5DK93RCL", "2679MF687A", "YOJ58O116E", "8MYC33932O", "6EC706HI7F", "333DO1RDJY", "269XH13919", "23PJ4252VL", "P6J2SFT80O", "B6A98VOI9I", "9Y3J3362RY", "JHM2AD7V9M", "M572600E5P", "GV54A213NN", "8DUH1N11BX" ] } } ] }