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Probistor

Probistor Capsules

Approved
Approval ID

d1db0c89-19ce-499d-96e0-67a909671b42

Product Type

DIETARY SUPPLEMENT

Effective Date

Sep 22, 2025

Manufacturers
FDA

Trivia Pharmaceuticals, LLC

DUNS: 119353862

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acidophilus/Pectin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84781-107
Product Classification
G
Generic Name
Acidophilus/Pectin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2025
FDA Product Classification

INGREDIENTS (3)

LACTOBACILLUS ACIDOPHILUSActive
Quantity: 200000000 [CFU] in 1 1
Code: 1PRR1V42V5
Classification: ACTIB
DICALCIUM PHOSPHATEActive
Quantity: 304 mg in 1 1
Code: L11K75P92J
Classification: ACTIB
PECTIN, CITRUSActive
Quantity: 20 mg in 1 1
Code: 47EQO8LE7H
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/22/2025

PACKAGING:

Probistor

HEALTH CLAIM SECTION

LOINC: 69719-3Updated: 9/22/2025

HEALTH CLAIM:

Probistor Probiotic Capsules

Supp Facts

STATEMENT OF IDENTITY SECTION

LOINC: 69718-5Updated: 9/22/2025

DESCRIPTION:

Probistor is an orally adminstered prescription probiotic dietary supplement.

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

84781-0107-30

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:

Trivia Pharmacueticals, LLC

Gilbert, AZ

WARNINGS SECTION

LOINC: 34071-1Updated: 9/22/2025

WARNINGS AND PRECAUTIONS:

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

LOINC: 34068-7Updated: 9/22/2025

DOSAGE AND ADMINISTRATION:

Usual adult dose is 2 capsules by mouth daily once daily, preferably with food, as a dietary supplement or as prescribed by a licensed medical practitioner.

Probistor 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 SECTION

LOINC: 42232-9Updated: 9/22/2025

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

LOINC: 50741-8Updated: 9/22/2025

STORAGE:

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

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Probistor - FDA Drug Approval Details