{"active_ingredient":["Active ingredients Each drop contains: Coffea cruda (Coffee) Unroasted Seed 10X Ignatia amara (St. Ignatius’ bean) Seed 8X Jalapa (Jalap) Tuber 8X Magnesium metallicum (Magnesium) 10X Passiflora incarnata (Passion flower) Aerial Parts 3X Phosphoricum acidum (Phosphoric acid) 14X Palladium metallicum (Palladium) 10X Tellurium metallicum (Tellurium) 10X"],"dosage_and_administration":["Directions To be taken 10 minutes away from food. Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water. Hold contents for about 20 seconds and swallow. To promote drop flow, invert bottle and shake before each use. Dosage frequency may be increased up to 6 times daily depending on the severity of symptoms. Adults and adolescents (12 years and older) Take 10 drops 3 times daily or as recommended by your healthcare practitioner. Children (under 12 years) .Take under the direction of your healthcare practitioner."],"effective_time":"20211110","id":"d06cb8b2-b26e-95ad-e053-2995a90aa3b0","inactive_ingredient":["Inactive ingredients Ethanol (beet), purified water"],"indications_and_usage":["Uses For the temporary relief of symptoms associated with irregular sleep patterns and ordinary restlessness. Product ‘Uses’ are based on Homeopathic Materia Medica and are not supported by clinical trials. These 'Uses' have not been evaluated by the Food and Drug Administration. Directions To be taken 10 minutes away from food. Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water. Hold contents for about 20 seconds and swallow. To promote drop flow, invert bottle and shake before each use. Dosage frequency may be increased up to 6 times daily depending on the severity of symptoms. Adults and adolescents (12 years and older) Take 10 drops 3 times daily or as recommended by your healthcare practitioner. Children (under 12 years) .Take under the direction of your healthcare practitioner."],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"brand_name":["PASSIFLORA PLEX"],"generic_name":["PASSIFLORA INCARNATA, IGNATIA AMARA, JALAPA, COFFEA CRUDA, MAGNESIUM METALICUM, PALLADIUM METALLICUM, TELLURIUM METALLICUM, PHOSPHORICUM ACIDUM"],"is_original_packager":[true],"manufacturer_name":["SanUp"],"nui":["N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0006342","M0016962","M0516536"],"package_ndc":["52503-1322-0"],"pharm_class_cs":["Allergens [CS]","Dietary Proteins [CS]","Plant Proteins [CS]","Seed Storage Proteins [CS]"],"pharm_class_epc":["Non-Standardized Food Allergenic Extract [EPC]","Non-Standardized Plant Allergenic Extract [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]"],"product_ndc":["52503-1322"],"product_type":["HUMAN OTC DRUG"],"route":["SUBLINGUAL"],"spl_id":["d06cb8b2-b26e-95ad-e053-2995a90aa3b0"],"spl_set_id":["937b6700-3ba8-0266-e053-2995a90a3318"],"substance_name":["PASSIFLORA INCARNATA FLOWERING TOP","ARABICA COFFEE BEAN","MAGNESIUM","STRYCHNOS IGNATII SEED","IPOMOEA PURGA ROOT","PALLADIUM","TELLURIUM","PHOSPHORIC ACID"],"unii":["CLF5YFS11O","3SW678MX72","I38ZP9992A","1NM3M2487K","4UDO46YBK2","5TWQ1V240M","NQA0O090ZJ","E4GA8884NN"],"upc":["0883196325306"]},"other_safety_information":["Do not use if seal is missing or broken. Store in a cool, dry place. Contents may not fill package in order to accommodate required labeling. Please rely on stated quantity."],"overdosage":["In case of overdose, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["NDC 62106-1322-0 UNDA PLEX PASSIFLORA PLEX Homeopathic Preparation For the temporary relief of symptoms associated with irregular sleep patterns and ordinary restlessness. Contains 60% Alcohol 30 mL (1 fl oz) Passiflora plex.jpg"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a health professional before use."],"purpose":["Uses For the temporary relief of symptoms associated with irregular sleep patterns and ordinary restlessness."],"recent_major_changes":["Indications & Usage section Addition of: \"Product ‘Uses’ are based on Homeopathic Materia Medica and are not supported by clinical trials. These 'Uses' have not been evaluated by the Food and Drug Administration.\""],"set_id":"937b6700-3ba8-0266-e053-2995a90a3318","spl_product_data_elements":["PASSIFLORA PLEX Passiflora incarnata, Ignatia amara, Jalapa, Coffea cruda, Magnesium metalicum, Palladium metallicum, Tellurium metallicum, Phosphoricum acidum WATER ALCOHOL PASSIFLORA INCARNATA FLOWERING TOP PASSIFLORA INCARNATA FLOWERING TOP ARABICA COFFEE BEAN ARABICA COFFEE BEAN MAGNESIUM MAGNESIUM STRYCHNOS IGNATII SEED STRYCHNOS IGNATII SEED IPOMOEA PURGA ROOT IPOMOEA PURGA ROOT PALLADIUM PALLADIUM TELLURIUM TELLURIUM PHOSPHORIC ACID PHOSPHORIC ACID"],"stop_use":["Stop use and ask a doctor if symptoms persist or worsen."],"version":"4","warnings":["Warnings Stop use and ask a doctor if symptoms persist or worsen. If pregnant or breastfeeding, 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."]}