REJUVAFLOR: Package Insert and Label Information

REJUVAFLOR- lactobacillus acidophilus capsule
Trell Pharma, LLC

HEALTH CLAIM:

REJUVAFLOR Capsules Dietary Supplement
Dispensed by Prescription

Supplement Facts
Serving Size: 1 Capsule Daily
Servings Per Container: 30
Amount Per Serving: % Daily Value

Probiotic blend

(Lactobacillus acidophilus)

10 billion CFU **
** Daily values not established

Other Ingredients: Maltodextrin, Vegetable Capsules

DESCRIPTION:

REJUVAFLOR 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.

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

WARNINGS AND PRECAUTIONS:

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

REJUVAFLOR 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 with or without food.

INDICATIONS AND USAGE

REJUVAFLOR 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:

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

82379-8755-1

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:
Trell Pharma, LLC
Tampa, FL 33626

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:

REJUVAFLOR
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REJUVAFLOR
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REJUVAFLOR
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REJUVAFLOR
lactobacillus acidophilus capsule
Product Information
Product Type Item Code (Source) NDC:82379-8755
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LACTOBACILLUS ACIDOPHILUS (LACTOBACILLUS ACIDOPHILUS) LACTOBACILLUS ACIDOPHILUS 10000000000 [CFU]
Inactive Ingredients
Ingredient Name Strength
MALTODEXTRIN
Product Characteristics
Color white Score no score
Shape capsule Size 25mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82379-8755-1 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
dietary supplement 02/04/2022
Labeler — Trell Pharma, LLC (118380801)

Revised: 11/2022 Trell Pharma, LLC

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