Label: NEWFLORA- probiotic capsule
- NHRIC Code(s): 82379-8757-1
- Packager: Trell Pharma
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated March 8, 2022
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STATEMENT OF IDENTITY
NewFlora
Other Ingredients: Maltodextrin, Vegetable Capsule.
NewFlora 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.
NewFlora should be administered under the supervision of a licensed medical practitioner.
NewFlora 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.
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SAFE HANDLING
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
NewFlora 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
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HOW SUPPLIED HEALTH CLAIM
NewFlora, Probiotic
Dietary Supplement
NHRIC: 82379-8757-01 *
Bottles contain 30 Capsules
Distributed by:
Trell Pharma
Tampa, FL*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.
- NewFlora
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INGREDIENTS AND APPEARANCE
NEWFLORA
probiotic capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:82379-8757 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:82379-8757-1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 03/04/2022 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 24 mm scoring 1 Labeler - Trell Pharma (118380801)