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Florraxyl Package Insert

Status:
Prescription (Rx) Facts
Strength:
0.67 mg, 25 mg, 4.5 mg, 80 mg, 0.15 mg, 60 mg, 300 mcg, 26 mg, 0.013 mg, 10 mcg, 0.28 mg, 20 mg
Drug class:
Active ingredients:
Similar drugs:

Prescribing information (package insert) - Florraxyl

Florraxyl is a prescription multivitamin/multimineral dietary supplement.

Florraxyl is a prescription multivitamin/multimineral dietary supplement formulated for the clinical dietary management of a buoptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.

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

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

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.

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.

One tablet daily or as directed by a physician.

Bottles of 30 Tablets (84460-903-30). Tablet is light blue, oblong.

*Florrax Pharmaceuticals does not represent this products code to be National Drug Code INDC). 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 B 12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner(64 FR 87 60). 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 (45 FR 69043, 69044) 3.) Federal register notice of March 5, 1996 (61 FR 8760)

STORAGE: 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.

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

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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Drug information for Florraxyl

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Blood Coagulation Factor, Calculi Dissolution Agent, Osmotic Laxative, Phosphate Binder, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Folic acid 0.67 mg, Magnesium oxide 25 mg, Alpha-tocopherol acetate, D- 4.5 mg, Calcium carbonate 80 mg, Potassium iodide 0.15 mg, Ascorbic acid 60 mg, Beta carotene 300 mcg, Pyridoxine hydrochloride 26 mg, Cyanocobalamin 0.013 mg, Cholecalciferol 10 mcg, Biotin 0.28 mg, Ferrous bisglycinate 20 mg
Dosage form Tablet
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) Florrax Pharmaceutical
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
0.67 mg, 25 mg, 4.5 mg, 80 mg, 0.15 mg, 60 mg, 300 mcg, 26 mg, 0.013 mg, 10 mcg, 0.28 mg, 20 mg – 30 in 1 bottle NDC 84460-903-30

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.