ZENTERA
Zentera Probiotic CapsulesDietary Supplement
d0941640-5d30-47cf-bc3b-e5efb79652a9
DIETARY SUPPLEMENT
May 23, 2025
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.
LACTOBACILLUS ACIDOPHILUS
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (2)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGING:
HEALTH CLAIM SECTION
HEALTH CLAIM:
Zentera Probiotic Capsules Dietary Supplement
Dispensed by Prescription
Other Ingredients: Maltodextrin, Vegetable Capsules
STATEMENT OF IDENTITY SECTION
DESCRIPTION:
Zentera Probiotic Capsules are 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.
Zentera Probiotic Capsules 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 SECTION
WARNINGS AND PRECAUTIONS:
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
GutVite 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 & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION:
Usual adult dose is 1 capsule by mouth daily with or without food.
PRECAUTIONS SECTION
HOW SUPPLIED:
Zentera Probiotic Capsules are supplied as clear capsules dispensed in plastic bottles of 30 ct.
84781-100-02
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
SAFE HANDLING WARNING SECTION
STORAGE:
Store at 20° - 25° C (68° - 77° F); excursions permitted to 15°-30°C (59°-86°F)[See USP Controlled Room Tempature].
Store in the Refrigerator after opening. DO NOT FREEZE.