MedPath

ReliBiotic

ReliBiotic

Approved
Approval ID

c35d602f-9aa5-4507-8619-4da538fa4789

Product Type

DIETARY SUPPLEMENT

Effective Date

May 23, 2025

Manufacturers
FDA

Redmont Pharmaceuticals, LLC

DUNS: 080843607

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

lactobacillus acidophilus and bifidobacterium animalis lactis

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71741-423
Product Classification
G
Generic Name
lactobacillus acidophilus and bifidobacterium animalis lactis
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (5)

Lactobacillus AcidophilusActive
Quantity: 16000000000 [CFU] in 1 1
Code: 1PRR1V42V5
Classification: ACTIB
Bifidobacterium Animalis LactisActive
Quantity: 15000000000 [CFU] in 1 1
Code: 5307V7XW8I
Classification: ACTIB
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM PALMITOSTEARATEInactive
Code: R4OXA9G5BV
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/23/2025

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

71741-423-30

ReliBiotic

PROBIOTIC SUPPORT

Lactobacillus Acidophilus
Bifidobacterium Animalis Lactis
31 Billion CFU's
DIETARY SUPPLEMENT

30 CAPSULES

Dispensed by Prescription

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

STATEMENT OF IDENTITY SECTION

LOINC: 69718-5Updated: 5/23/2025

Supplement Facts

Serving size 1 Capsule

Amount per Serving:

% Daily Value

  • Daily value not established

Lactobacillus Acidophilus

16 Billion

Bifidobacterium Animalis Lactis

15 Billion

OTHER INGREDIENTS: Modified Cellulose, Silicon Dioxide, Magnesium Stearate.

Preservative Free and Gluten Free

HEALTH CLAIM SECTION

LOINC: 69719-3Updated: 5/23/2025

© 2025 Redmont Pharmaceuticals, LLC
423111-0625

WARNINGS SECTION

LOINC: 34071-1Updated: 5/23/2025

WARNING

ReliBiotic 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 other medications.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/23/2025

DOSAGE AND ADMINISTRATION

Usual adult dose is 1 capsule once or twice daily or as prescribed by a licensed medical practitioner.

SAFE HANDLING WARNING SECTION

LOINC: 50741-8Updated: 5/23/2025

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

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