NewFlora

Manufacturer
Trell Pharma
Effective date
2022-03-08
Label type
DIETARY SUPPLEMENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:50:23

Label at a glance#

ProductNewFlora
Active ingredientLACTOBACILLUS ACIDOPHILUS
Label structure6 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY

STATEMENT OF IDENTITY SECTION

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.

DOSAGE

DOSAGE & ADMINISTRATION SECTION

Usual Adult dose is one capsule once daily, or as prescribed by a licensed medical practitioner.
If you are pregnant or nursing, ask a healthcare professional.

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

SAFE HANDLING

PRECAUTIONS SECTION

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

STORAGE

HEALTH CLAIM SECTION

Store at 2° to 8°C (35° to 46°F).
Store in the refrigerator after opening, DO NOT freeze.

HOW SUPPLIED HEALTH CLAIM

HEALTH CLAIM SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NewFloraNewFlora

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1370001Lactobacillus acidophilus 10 Billion UNT Oral CapsulePSN2
1370001Lactobacillus acidophilus 10000000000 UNT Oral CapsuleSCD2
1370001Lactobacillus acidophilus 10 Billion UNT Oral CapsuleSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82379-8757-1NewFlora30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82379-8757NEWFLORA (PROBIOTIC) CAPSULE [TRELL PHARMA]21 package rows20220309_e5d564c8-e09f-45d4-9045-bd5471137640.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82379-8757-1EA - Each82379-875764b2ef5b-59a5-4ecd-a6c5-8ec5c682390312022-04-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82379-875782379-8757-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOBACILLUS ACIDOPHILUS1PRR1V42V5ACTIB
MALTODEXTRIN7CVR7L4A2DIACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.