FLORRAXIS- lactobacillus acidophilus,bifidobacterium animalis lactis tablet

Florraxis by

Drug Labeling and Warnings

Florraxis by is a Prescription medication manufactured, distributed, or labeled by Florrax Pharmaceutical Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Florraxis is an orally administered prescription probiotic dietary supplement.

INDICATIONS & USAGE

Florraxis 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. Should be administered under the supervision of a licensed medical practitioner.

CONTRAINDICATIONS

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

PRECAUTIONS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

WARNINGS

Accidental overdose of iron-containing products is a leading cause of fatal poising in children under 6. Keep this product out of the reach of children. In the case of accidental overdose, call a doctor or poison control center immediately.

Preservative Free and Gluten Free

Allergens: None

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about serious adverse events. To reports adverse side effects or to obtain product information, contact Florrax Pharmaceuticals at 888-321-2821.

DOSAGE & ADMINISTRATION

One tablet daily or as directed by a physician.

INACTIVE INGREDIENT

Modified Cellulose, Silicon Dioxide, Magnesium Stearate.

HOW SUPPLIED

Bottles of 30 Tablets (84460-602-30). Tablet is light blue, oblong.

SPL UNCLASSIFIED SECTION

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

This products is a prescription-folate with or without other dietary ingredients the - due to increased folate levels increased risk associated with masking B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner(64 FR 8760). 1-3 the most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only 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 statues as applicable. The ingredients, indication or claims of this product are not to be construed to be Drug claims.

1.) Federal register Notice of August 2, 1973 (39 FR 20750)
2.) Federal Register Notice of October 17, 1980 (4S FR 69043, 69044)

3.) Federal register notice of March 5, 1996 (61 FR 8760)

STORAGE AND HANDLING

: Store at 20- 25 degree C (68-77 F) excersions permitted to 15 -30 degree C (59-86 F) {See USP controlled Room Temperature} Avoid excessive heat, light and moisture.

PRINCIPAL DISPLAY PANEL

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

MADE IN USA
Distributed by:
888-321-2821
Florrax Pharmaceutical
Dallas, TX 75161

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

INGREDIENTS AND APPEARANCE

FLORRAXIS 
lactobacillus acidophilus,bifidobacterium animalis lactis tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 84460-602
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5)	LACTOBACILLUS ACIDOPHILUS	16000000000 [CFU]
BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I) (BIFIDOBACTERIUM ANIMALIS LACTIS - UNII:5307V7XW8I)	BIFIDOBACTERIUM ANIMALIS LACTIS	15000000000 [CFU]

Product Characteristics
Color	blue (light blue)	Score	no score
Shape	OVAL	Size	23mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84460-602-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/12/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/12/2024

Labeler - Florrax Pharmaceutical Corp. (119257612)