BIOZEN- lactobacillus acidophilus and bifidobacterium lactis capsule

BIOZEN by

Drug Labeling and Warnings

BIOZEN by is a Other medication manufactured, distributed, or labeled by Trivia Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM:

BioZen Capsules Dietary Supplement
Dispensed by Prescription

Supplement Facts
Serving Size: 1 Capsule Daily
Servings Per Container: 30
Amount Per Serving:	% Daily Value
Lactobacillus acidophilus	8 billion CFU **
Bifidobacterium Lactis	7.5 Billion CFU **
** Daily values not established

Other Ingredients: Maltodextrin, Vegetable Capsules

DESCRIPTION:

BioZen 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.

BioZen 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:

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

BioZen 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:

Usual adult dose is 1 capsule by mouth daily once or twice daily, or as prescribed by a licensed medical practitioner.

BioZen 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.

HOW SUPPLIED:

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

84781-101-01

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:

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:

INGREDIENTS AND APPEARANCE

BIOZEN 
lactobacillus acidophilus and bifidobacterium lactis capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:84781-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5)	LACTOBACILLUS ACIDOPHILUS	8000000000 [CFU]
BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I) (BIFIDOBACTERIUM ANIMALIS LACTIS - UNII:5307V7XW8I)	BIFIDOBACTERIUM ANIMALIS LACTIS	7500000000 [CFU]

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:84781-101-01	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		01/20/2025

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
size (solid drugs)	25 mm
scoring	1

Labeler - Trivia Pharmaceuticals, LLC (119353862)