Probiovex - Blue Heron Pharmaceuticals, LLC

Manufacturer
Blue Heron Pharmaceuticals, LLC
Effective date
2026-07-31
Label type
DIETARY SUPPLEMENT
Version
1
Source
daily-update
Hydrated at
2026-08-04 03:34:08

Label at a glance#

ProductProbiovex
Active ingredientLACTOBACILLUS PLANTARUM 299
Label structure7 sections

Label contents#

Full prescribing information#

Supplement Facts:

HEALTH CLAIM SECTION

Probiovex Probiotic Capsules

Dispensed by Prescription

Supp FactsSupp Facts

Description:

STATEMENT OF IDENTITY SECTION

Probiovex Probiotic Capsules are an orally adminstered prescription probiotic dietary supplement.

Probiovex Probiotic Capsules are clear capsules dispensed in plastic bottles of 30 ct.

85622-0130-30

Reserved for Professional Recommendation

This listed product is not a National Drug Code, but instead has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

These statements have not been evaluated by the Food and Drug Administration.  This product is not intended to diagnose, treat, cure or prevent any disease.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:

Blue Heron Pharmaceuticals

Lutz, FL 33559

Warnings:

WARNINGS SECTION

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

As with any supplement, if you are pregnant, nursing, taking medication, or have a medical condition, ask a health professional before taking this product.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Dosage:

DOSAGE & ADMINISTRATION SECTION

Usual adult dose is 4 capsules by mouth daily once daily, or as prescribed by a licensed medical practitioner.

Probiovex is an orally administered prescription probiotic formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.

Precautions:

PRECAUTIONS SECTION

CONTRAINDICATIONS
This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

PRECAUTIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

ADVERSE REACTIONS
Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.

KEEP OUT OF THE REACH OF CHILDREN.

Storage:

SAFE HANDLING WARNING SECTION

STORAGE:
Handling (before opening):
Product is sensitive to moisture and heat. Keep bottle tightly closed in a dry, cool place. Store at 200C to 250C (680F to 770F).

Handling (after opening):
Store in the refrigerator after opening, DO NOT FREEZE. Store at 20C to 80C (350F to 460F). 

Label:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85622-13085622-130-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOBACILLUS PLANTARUM 2996H16YUE9W5ACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.