FDA.reportPublic FDA data

Lactobacillus Tablets

Manufacturer
Krewe Pharma, LLC
Effective date
2025-10-28
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:52:32

Label at a glance#

ProductLactobacillus
Active ingredientLACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS DELBRUECKII BULGARICUS
Label structure7 sections

Dosage and administration

Usual dosage is 4 tablets 3 to 4 times daily, or as recommended by your healthcare professional.

Label contents#

Full prescribing information#

Supplement Facts:

HEALTH CLAIM SECTION

Supp FactsSupp Facts

Description:

STATEMENT OF IDENTITY SECTION

FloraMax is supplied as white, round tablets dispensed in plastic bottles of 50 ct.

87021-0101-50

Reserved for Professional Recommendation

This listed product is not a National Drug Code, but instead has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

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

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:

Krewe Pharma

New Port Richey, FL 34652

Warnings:

WARNINGS SECTION

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

As with any supplement, if you are pregnant, nursing, taking medication, or have a medical condition, ask a health professional before taking this product.

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

Dosage and Administration:

DOSAGE & ADMINISTRATION SECTION

Usual dosage is 4 tablets 3 to 4 times daily, or as recommended by your healthcare professional.

Precautions:

PRECAUTIONS SECTION

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

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

ADVERSE REACTIONS
Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.

KEEP OUT OF THE REACH OF CHILDREN.

Storage:

SAFE HANDLING WARNING SECTION

Store at 20° - 25° C (68° - 77° F); excursions permitted to 15°-30°C (59°-86°F)[See USP Controlled Room Tempature].

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1293033Lactobacillus acidophilus 0.2 MG / Lactobacillus bulgaricus 0.2 MG Oral TabletPSN1
1293033Lactobacillus acidophilus 0.2 MG / Lactobacillus delbrueckii subsp. bulgaricus 0.2 MG Oral TabletSCD1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 12887021-0101-50Lactobacillus Oral Tablet Label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87021-101-50Lactobacillus50 in 1 BOTTLETABLET501

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87021-10187021-101-50

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
LACTOBACILLUS DELBRUECKII BULGARICUSHU1W4L947HACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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