PROBIZEN- probiotic capsule

Probizen by

Drug Labeling and Warnings

Probizen by is a Other medication manufactured, distributed, or labeled by Trell Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Probizen   

Other Ingredients: PretiX Prebiotic Blend, Standardized Probiotic Culture (Guar Gum, Hyaluronic Acid, Maltodextrin, Soy Protein Isolate), Rice Flour, Vegetable Cellulose (Capsule), Silica Dioxide
Probizen 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.
Probizen should be administered under the supervision of a licensed medical practitioner.
Probizen is manufactured in accordance with Current Good Manufacturing Practice for foods, using ingredients that have been approved by the U.S. Food and Drug Administration (FDA) as food additives or are Generally Recognized as Safe (GRAS) for their intended use.

DOSAGE

Take one (1) capsule once to twice daily preferably with meals or as directed by medical practitioner.

If you are pregnant or nursing, ask a healthcare professional.

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

SAFE HANDLING

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

Probizen should only be used under the direction and supervision of a licensed medical practitioner.

WARNING: Children under 18, pregnant or nursing women, and individuals with known medical conditions should consult a physician before using this or any dietary supplement.

In case of accidental overdoes, call a doctor or poison control center immediately.

KEEP OUT OF REACH OF CHILDREN

STORAGE

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F).

HOW SUPPLIED HEALTH CLAIM

Probizen Probiotic Capsule

Dietary Supplement

NHRIC: 82379-8760-1 *

Bottles contain 30 Capsules

Distributed in the USA by:
Trell Pharma, LLC

*Does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

† The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product by prescription. This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.

Probizen

INGREDIENTS AND APPEARANCE

PROBIZEN 
probiotic capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:82379-8760
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5)	LACTOBACILLUS ACIDOPHILUS	16000000000 [CFU]
BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I) (BIFIDOBACTERIUM ANIMALIS LACTIS - UNII:5307V7XW8I)	BIFIDOBACTERIUM ANIMALIS LACTIS	16000000000 [CFU]

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:82379-8760-1	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		08/25/2022

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

Labeler - Trell Pharma (118380801)