Label: FLORRAXYL- beta carotene, ascorbic acid, cholecalciferol, dl-alpha tocopherol acetate, pyridoxine hci, biotin, folate, cyanocobalamin, calcium carbonate, magnesium oxide, ferrocheltm, potassium iodide tablet
- NDC Code(s): 84460-903-30
- Packager: Florrax Pharmaceutical
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated January 3, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DESCRIPTION
- INDICATIONS & USAGE
- CONTRAINDICATIONS
- PRECAUTIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
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SPL UNCLASSIFIED SECTION
*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)
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STORAGE AND HANDLING
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 PharmaceuticalDallas, TX 75161
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FLORRAXYL
beta carotene, ascorbic acid, cholecalciferol, dl-alpha tocopherol acetate, pyridoxine hci, biotin, folate, cyanocobalamin, calcium carbonate, magnesium oxide, ferrocheltm, potassium iodide tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:84460-903 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 0.67 mg MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION 25 mg .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 4.5 mg CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 80 mg POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 0.15 mg ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 60 mg BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE 300 ug PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 26 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 0.013 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 10 ug BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 0.28 mg FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 20 mg Product Characteristics Color blue Score no score Shape OVAL Size 12mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84460-903-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2025 Labeler - Florrax Pharmaceutical (119257612)