FDA.reportPublic FDA data

WellPro 31

Manufacturer
Redmont Pharmaceuticals, LLC
Effective date
2023-10-25
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:50:53

Label at a glance#

ProductWellPro 31
Active ingredientLactobacillus Acidophilus, Bifidobacterium Animalis Lactis
Label structure12 sections

Dosage and administration

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

Storage and handling

Store 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Avoid excessive heat, light, moisture and exceeding 85% humidity. Keep in a cool, dry place. TAMPER EVIDENT: Do not use if seal is broken or missing.

Label contents#

Full prescribing information#

HEALTH CLAIM SECTION

71741-376-30
Dietary Supplement
Dispensed by Prescription

DESCRIPTION

HEALTH CLAIM SECTION

WellPro 31 is an orally administered prescription probiotic dietary supplement.

STATEMENT OF IDENTITY SECTION

Supplement Facts
Serving size 1 Capsule
Amount per Serving:% Daily Value
Lactobacillus Acidophilus16 Billion*
Bifidobacterium Animalis Lactis15 Billion*

* Daily value not established

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

Preservative Free and Gluten Free

INDICATIONS

HEALTH CLAIM SECTION

WellPro 31 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. WellPro 31 should be administered under the supervision of a licensed medical practitioner.

CONTRAINDICATIONS

HEALTH CLAIM SECTION

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING

WARNINGS SECTION

WellPro 31 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.

ADVERSE REACTIONS

HEALTH CLAIM SECTION

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact Redmont Pharmaceuticals, LLC at 1-800-986-5909.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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

HOW SUPPLIED

HEALTH CLAIM SECTION

Bottle of 30 capsules (71741-376-302). Capsule is off-white, oblong.

2 Redmont Pharmaceuticals does not represent this product code to be National Drug Code (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

STORAGE AND HANDLING

SAFE HANDLING WARNING SECTION

Store 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Avoid excessive heat, light, moisture and exceeding 85% humidity. Keep in a cool, dry place.

TAMPER EVIDENT: Do not use if seal is broken or missing.

HEALTH CLAIM SECTION

MADE IN USA

Distributed by:

Redmont Pharmaceuticals, LLC
Birmingham, AL 35209
800-986-5909

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any diseases.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

© 2023 Redmont Pharmaceuticals, LLC
376111-1023

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

71741-376-30

WellPro 31

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
PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2043695Lactobacillus acidophilus 16 Billion UNT / Bifidobacterium animalis 15 Billion UNT Oral CapsulePSN1
2043695Bifidobacterium animalis 15000000000 UNT / Lactobacillus acidophilus 16000000000 UNT Oral CapsuleSCD1
2043695Bifidobacterium animalis 15,000,000,000 UNT / Lactobacillus acidophilus 16,000,000,000 UNT Oral CapsuleSY1
2043695Bifidobacterium animalis lactis 15,000,000,000 UNT / Lactobacillus acidophilus 16,000,000,000 UNT Oral CapsuleSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71741-376-30WellPro 3130 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71741-376WELLPRO 31 (LACTOBACILLUS ACIDOPHILUS AND BIFIDOBACTERIUM ANIMALIS LACTIS) CAPSULE [REDMONT PHARMACEUTICALS, LLC]11 package rows20231027_45a8ba6f-ff50-44ff-9502-3334e807ab39.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71741-37671741-376-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
Lactobacillus Acidophilus1PRR1V42V5ACTIB
Bifidobacterium Animalis Lactis5307V7XW8IACTIB
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
Silicon DioxideETJ7Z6XBU4IACT
MAGNESIUM PALMITOSTEARATER4OXA9G5BVIACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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