Label: REVITAFLOR- lactobacillus acidophilus capsule
- NHRIC Code(s): 82379-8758-1
- Packager: Trell Pharma, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated September 30, 2023
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HEALTH CLAIM:
REVITAFLOR 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
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DESCRIPTION:
REVITAFLOR 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.
REVITAFLOR should be administered under the supervision of a licensed medical practitioner.
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WARNINGS AND PRECAUTIONS:
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
REVITAFLOR 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.
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DOSAGE AND ADMINISTRATION:
Usual adult dose is 1 capsule by mouth daily with or without food.
INDICATIONS AND USAGE
REVITAFLOR 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.
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HOW SUPPLIED:
REVITAFLOR is supplied as clear capsules dispensed in plastic bottles of 30 ct.
82379-8758-1
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:
- PACKAGING:
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INGREDIENTS AND APPEARANCE
REVITAFLOR
lactobacillus acidophilus capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:82379-8758 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:82379-8758-1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 09/30/2023 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)