REFLORASTOR CapsulesDietary Supplement

REFLORASTOR by

Drug Labeling and Warnings

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

Drug Details [pdf]

REFLORASTOR- lactobacillus acidophilus capsule 
Trell Pharma, LLC

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REFLORASTOR Capsules
Dietary Supplement

HEALTH CLAIM:

REFLORASTOR 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:

REFLORASTOR 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.

REFLORASTOR 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.

REFLORASTOR 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

REFLORASTOR 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:

Promella in Prebiotic is supplied as clear capsules dispensed in HDPE plastic bottles of 56ct.

82379-8754-1

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:

Product is sensitive to moisture and heat. Keep bottle tightly closed in a dry, cool place before opening.  Store in the refrigerator after opening, DO NOT FREEZE. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

KEEP THIS OUT OF THE REACH OF CHILDREN.

PACKAGING:

REFLORASTOR 
lactobacillus acidophilus capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:82379-8754
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5)	LACTOBACILLUS ACIDOPHILUS	10000000000 [CFU]

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:82379-8754-1	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		01/25/2022	03/04/2022

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

Labeler - Trell Pharma, LLC (118380801)

Revised: 3/2022

Document Id: 3d832a90-c953-45db-a8c0-79a111ee49d4

58476-3

Set id: 58b1a48a-4d96-4e38-b524-1eb7ca5249f7

Version: 2

Effective Time: 20220304