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Folixia Package Insert

Status:
Prescription (Rx) Facts
Strength:
20 mg, 0.15 mg, 26 mg, 0.3 mg, 60 mg, 0.1 mg, 0.28 mg, 1.67 mg, 0.013 mg, 80 mg, 25 mg, 4.5 mg
Drug class:
Active ingredients:
Similar drugs:

Prescribing information (package insert) - Folixia

Folixia is a prescription multivitamin/multimineral dietary supplement.

Folixia is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.

Folixia 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. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

WARNING 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 Oncora Pharma at 888-321-2821.

One tablet daily or as directed by a physician.

Bottles of 30 Tablets (85477-902-30). Tablet is light blue, oblong.

*Oncora Pharma 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 (45 FR 69043, 69044)

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

Storage and Handing

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

Oncora Pharma

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 Folixia

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 Ferrous bisglycinate 20 mg, Potassium iodide 0.15 mg, Pyridoxine hydrochloride 26 mg, Beta carotene 0.3 mg, Ascorbic acid 60 mg, Cholecalciferol 0.1 mg, Biotin 0.28 mg, Folic acid 1.67 mg, Cyanocobalamin 0.013 mg, Calcium carbonate 80 mg, Magnesium oxide 25 mg, Alpha-tocopherol acetate, DL- 4.5 mg
Dosage form Tablet
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) Oncora Pharma, LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
20 mg, 0.15 mg, 26 mg, 0.3 mg, 60 mg, 0.1 mg, 0.28 mg, 1.67 mg, 0.013 mg, 80 mg, 25 mg, 4.5 mg – 30 in 1 bottle NDC 85477-902-30

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.