PROBENTRA- probiotic dietary supplement capsules capsule

Probentra by

Drug Labeling and Warnings

Probentra by is a Prescription medication manufactured, distributed, or labeled by Oncora Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

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.)

DOSAGE AND ADMINISTRATION

Adults: Take two (2) capsules once daily, or as directed by a licensed healthcare practitioner.

CONTRAINDICATIONS

Probentra™ is contraindicated in individuals with known hypersensitivity to any of its ingredients.

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.

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.

HOW SUPPLIED

Probentra™ (NDC: 85477-712-30) is supplied in bottles of 30 capsules.

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.

Principal Display Panel

85477-712-30
Probentra
40 Billion CFU
30 Capsules
Dispensed by Prescription

INGREDIENTS AND APPEARANCE

PROBENTRA 
probiotic dietary supplement capsules capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 85477-712
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTOBACILLUS ACIDOPHILUS LA 14 (UNII: D4S8K64J5Z) (LACTOBACILLUS ACIDOPHILUS LA 14 - UNII:D4S8K64J5Z)	LACTOBACILLUS ACIDOPHILUS LA 14	400 mg
BIFIDOBACTERIUM ANIMALIS LACTIS BL04 (UNII: K1YRS2QLN2) (BIFIDOBACTERIUM ANIMALIS LACTIS BL04 - UNII:K1YRS2QLN2)	BIFIDOBACTERIUM ANIMALIS LACTIS BL04	400 mg
LACTIPLANTIBACILLUS PLANTARUM (UNII: QFC21096ON) (LACTIPLANTIBACILLUS PLANTARUM - UNII:QFC21096ON)	LACTIPLANTIBACILLUS PLANTARUM	400 mg
LACTICASEIBACILLUS PARACASEI LPC-37 (UNII: GXW9U52VV9) (LACTICASEIBACILLUS PARACASEI LPC-37 - UNII:GXW9U52VV9)	LACTICASEIBACILLUS PARACASEI LPC-37	400 mg
LESSONIA NIGRESCENS (UNII: HTV58LVI9P) (LESSONIA NIGRESCENS - UNII:HTV58LVI9P)	LESSONIA NIGRESCENS	30 mg
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES (UNII: N2UDM48ZD6) (BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES - UNII:N2UDM48ZD6)	BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES	12 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LEUCINE (UNII: GMW67QNF9C)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85477-712-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/23/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/23/2026

Labeler - Oncora Pharma, LLC (119482542)