Bionara Ultra Capsule
FDA Label NDC 85477-710

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 Bionara Ultra (NDC 85477-710). 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 product description, indications and usage, dosage and administration, warnings, contraindications, storage, how supplied, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Product Description

Bionara Ultra™ is a prescription probiotic dietary supplement containing a proprietary blend of probiotic bacteria providing 60 billion CFU per serving (2 capsules), combined with prebiotic and polysaccharide support ingredients.

Each serving (2 capsules) contains 820 mg of proprietary probiotic blend delivering 60 billion CFU, including:

  • MATREK® (Bi-Pass Technology)
  • Lactobacillus acidophilus (La-14)
  • Bifidobacterium lactis (Bl-04)
  • Lactobacillus plantarum (Lp-115)
  • Lactobacillus paracasei (Lpc-37)

Indications And Usage

Bionara Ultra™ is a prescription probiotic supplement intended to support gastrointestinal health and maintain normal intestinal flora balance.

Dispensed by prescription under medical supervision.

Dosage And Administration

Usual adult dose is 2 capsules once or twice daily or as prescribed by a licensed medical practitioner.

Warnings

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. In case of accidental overdose, call a doctor or poison control center immediately.

If pregnant, lactating, or trying to conceive, consult with a licensed healthcare professional prior to use.

Contraindications

None known.

Storage

Store at 20°–25°C (68°–77°F).
Excursions permitted to 15°–30°C (59°–86°F) [See USP Controlled Room Temperature].

Avoid excessive heat, light, moisture, and exceeding 85% humidity.

How Supplied

Bionara Ultra™ is supplied as:

  • 30 capsules per bottle
  • NDC 85477-710-30

    • MANUFACTURER INFORMATION

    Manufactured for:
    Oncora Pharma
    Dallas, TX 75228

Principal Display Panel

85477-710-30
Bionara
ULTRA
60 billion CFU
30 Capsules

85477-710-30bionaraultra60 Billion Cfu30 Capsules (Bionara Ultra 01)

85477-710-30bionaraultra60 Billion Cfu30 Capsules (Bionara Ultra 01)

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