Probentra Capsule
FDA Label NDC 85477-712

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oncora Pharma, Llc for the product Probentra (NDC 85477-712). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, indications and usage, dosage and administration, contraindications, warnings and precautions, adverse reactions, how supplied, storage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

85477-712-30probentra40 Billion Cfu30 Capsulesdispensed By Prescription (Probentra 01)

85477-712-30probentra40 Billion Cfu30 Capsulesdispensed By Prescription (Probentra 01)

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