Label: REJUVAFLOR- lactobacillus acidophilus capsule
- NHRIC Code(s): 82379-8755-1
- Packager: Trell Pharma, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated November 15, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
HEALTH CLAIM:
REJUVAFLOR Capsules Dietary Supplement
Dispensed by PrescriptionSupplement 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:
-
INGREDIENTS AND APPEARANCE
REJUVAFLOR
lactobacillus acidophilus capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:82379-8755 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:82379-8755-1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 02/04/2022 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)
