Florastart Probiotic Capsules Dietary Supplement

Manufacturer
Trivia Pharmaceuticals, LLC
Effective date
2025-02-05
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:51:25

Label at a glance#

ProductFLORASTART
Active ingredientSACCHAROMYCES CEREVISIAE VAR. BOULARDII CNCM I-1079
Label structure7 sections

Dosage and administration

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

Label contents#

Full prescribing information#

HEALTH CLAIM:

HEALTH CLAIM SECTION

Florastart Capsules

Dietary Supplement

Dispensed by Prescription

 Supplement Facts
 Serving Size: 2 Capsules Daily   
 Servings Per Container: 15
 Amount Per Serving: % Daily Value
 Saccharomyces Boulardii  500   mg **
** Daily values not established

Other Ingredients: Maltodextrin, Vegetable Capsules

DESCRIPTION:

STATEMENT OF IDENTITY SECTION

Florastart 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.

Florastart should be administered under the supervision of a licensed medical practitioner.

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.

WARNINGS AND PRECAUTIONS:

WARNINGS SECTION

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

Florastart should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

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

HOW SUPPLIED:

PRECAUTIONS SECTION

Florastart is supplied as clear capsules dispensed in plastic bottles of 30 ct.   

84781-102-01

Reserved for Professional Recommendation

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:
Trivia Pharmaceuticals

Gilbert, AZ

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).

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

PACKAGING:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Florastart LabelFlorastart LabelFlorastart LabelFlorastart Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84781-102-01FLORASTART30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84781-102FLORASTART (SACCHAROMYCES BOULARDII) CAPSULE [TRIVIA PHARMACEUTICALS, LLC]11 package rows20250207_bb7e1a2e-fbff-454f-8163-081879a5d80b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84781-102-01EA - Each84781-102588b0034-120b-498f-b4d2-6f95f36a3f7a12025-03-04

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84781-10284781-102-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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