Probitran: Package Insert and Label Information

PROBITRAN- lactobacillus acidophilus and bifidobacterium animalis lactis capsule
PureTek Corporation

STATEMENT OF IDENTITY

Probitran™

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Other Ingredients: Potato Starch, Magnesium Stearate,Ascorbic Acid, Vegetable Capsule (Hydroxypropylmethylcellulose).
Probitran™ 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.
Probitran™ should be administered under the supervision of a licensed medical practitioner.
Probitran™ 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

Usual Adult dose is one capsule once daily, or as prescribed by a licensed medical practitioner.
If you are pregnant or nursing, ask a healthcare professional.

Probitran™ 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.

Probitran™ 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.

KEEP OUT OF REACH OF CHILDREN

STORAGE

Store at 20° to 25°C (68° to 77°F).
Keep in a cool dry place.

HOW SUPPLIED HEALTH CLAIM

Probitran™, Probiotic

Dietary Supplement

NHRIC: 59088-183-54 *

Bottles contain 30 Capsules

Manufactured in Canada and
Distributed in the USA by:
PureTek Corporation
Panorama City, CA 91402
Questions? Call toll-free:
1-877-921-7873

*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.

Probitran™

List No: 18354IAA Rev:38306

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PROBITRAN
probiotic capsule
Product Information
Product Type Item Code (Source) NDC:59088-183
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LACTOBACILLUS ACIDOPHILUS (LACTOBACILLUS ACIDOPHILUS) LACTOBACILLUS ACIDOPHILUS 16000000000 [CFU]
BIFIDOBACTERIUM ANIMALIS LACTIS (BIFIDOBACTERIUM ANIMALIS LACTIS) BIFIDOBACTERIUM ANIMALIS LACTIS 15000000000 [CFU]
Product Characteristics
Color white (Off white) Score no score
Shape capsule Size 25mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59088-183-54 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 05/03/2021
Labeler — PureTek Corporation (785961046)

Revised: 05/2021 PureTek Corporation

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