{"adverse_reactions":["ADVERSE REACTIONS Probiotic supplementation may occasionally result in mild gastrointestinal symptoms such as bloating, gas, or abdominal discomfort. If adverse reactions occur, discontinue use and consult a healthcare professional."],"contraindications":["CONTRAINDICATIONS Probentra™ is contraindicated in individuals with known hypersensitivity to any of its ingredients."],"description":["DESCRIPTION Probentra™ is a prescription-dispensed oral probiotic dietary supplement formulated to support gastrointestinal health and maintain normal intestinal flora. Each serving (two capsules) delivers 40 billion colony-forming units (CFU) of beneficial probiotic organisms combined with marine polysaccharide and fructooligosaccharide (FOS). The proprietary probiotic blend includes: Lactobacillus acidophilus (La-14®) Bifidobacterium lactis (Bl-04®) Lactobacillus plantarum (Lp-115®) Lactobacillus paracasei (Lpc-37®) The formulation utilizes MAKTrek® Bi-Pass Technology to support probiotic viability during gastrointestinal transit. Probentra™ is intended for use under the supervision of a licensed healthcare practitioner."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults: Take two (2) capsules once daily, or as directed by a licensed healthcare practitioner."],"effective_time":"20260225","how_supplied":["HOW SUPPLIED Probentra™ (NDC 85477-712-30) is supplied in bottles of 30 capsules."],"id":"e357f4a7-006b-4dcf-8f8c-8157f5f817ef","indications_and_usage":["INDICATIONS AND USAGE Probentra™ is indicated as a probiotic dietary supplement to support digestive health and promote balance of normal intestinal microflora. It is dispensed by prescription and intended for use under medical supervision as part of a dietary supplementation plan. (Notice: no disease treatment claims — this keeps you clean in Rx dietary supplement lane.)"],"openfda":{"brand_name":["Probentra"],"generic_name":["PROBIOTIC DIETARY SUPPLEMENT CAPSULES"],"is_original_packager":[true],"manufacturer_name":["Oncora Pharma, LLC"],"package_ndc":["85477-712-30"],"product_ndc":["85477-712"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"spl_id":["e357f4a7-006b-4dcf-8f8c-8157f5f817ef"],"spl_set_id":["7c0e1b3e-f1a3-451d-a5c6-45bdf13274f8"],"substance_name":["LACTOBACILLUS ACIDOPHILUS LA 14","BIFIDOBACTERIUM ANIMALIS LACTIS BL04","LACTIPLANTIBACILLUS PLANTARUM","LACTICASEIBACILLUS PARACASEI LPC-37","LESSONIA NIGRESCENS","BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES"],"unii":["D4S8K64J5Z","K1YRS2QLN2","QFC21096ON","GXW9U52VV9","HTV58LVI9P","N2UDM48ZD6"]},"package_label_principal_display_panel":["Principal Display Panel 85477-712-30 Probentra 40 Billion CFU 30 Capsules Dispensed by Prescription 85477-712-30 Probentra 40 Billion CFU 30 Capsules Dispensed by Prescription"],"set_id":"7c0e1b3e-f1a3-451d-a5c6-45bdf13274f8","spl_product_data_elements":["Probentra Probiotic Dietary Supplement Capsules LACTOBACILLUS ACIDOPHILUS LA 14 LACTOBACILLUS ACIDOPHILUS LA 14 BIFIDOBACTERIUM ANIMALIS LACTIS BL04 BIFIDOBACTERIUM ANIMALIS LACTIS BL04 LACTIPLANTIBACILLUS PLANTARUM LACTIPLANTIBACILLUS PLANTARUM LACTICASEIBACILLUS PARACASEI LPC-37 LACTICASEIBACILLUS PARACASEI LPC-37 LESSONIA NIGRESCENS LESSONIA NIGRESCENS BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES HYPROMELLOSE, UNSPECIFIED MALTODEXTRIN LEUCINE"],"spl_unclassified_section":[""],"storage_and_handling":["STORAGE Store at 20°–25°C (68°–77°F); excursions permitted to 15°–30°C (59°–86°F). Protect from excessive heat, moisture, and light."],"version":"1","warnings_and_cautions":["WARNINGS AND PRECAUTIONS If pregnant, nursing, or attempting to conceive, consult a licensed healthcare professional prior to use. Keep out of reach of children. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six years of age. In case of accidental overdose, call a physician or poison control center immediately."]}