MICROBALANCE
Microbalance Capsules
36882837-7838-4505-8bcb-9ed868c807bd
DIETARY SUPPLEMENT
Sep 19, 2025
Blue Heron Pharmaceuticals, LLC
DUNS: 137019051
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LACTOBACILLUS ACIDOPHILUS AND BIFIDOBACTERIUM LACTIS
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (3)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGING:
HEALTH CLAIM SECTION
HEALTH CLAIM:
Microbalance Probiotic Capsules
STATEMENT OF IDENTITY SECTION
DESCRIPTION:
Microbalance Probiotic Capsules are clear capsules dispensed in plastic bottles of 30 ct.
85622-0102-30
Reserved for Professional Recommendation
Microbalance Probiotic Capsules should be administered under the supervision of a licensed medical practitioner.
Microbalance 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.
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 SECTION
WARNINGS:
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 & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION:
Usual adult dose is 2 capsules by mouth daily once daily, or as prescribed by a licensed medical practitioner.
PRECAUTIONS SECTION
PRECAUTIONS:
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.
SAFE HANDLING WARNING SECTION
STORAGE:
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).