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Folyra Package Insert

Status:
Prescription (Rx) Facts
Strength:
300 mcg, 60 mg, 10 mcg, 4.5 mg, 26 mg, 0.28 mg, 1.67 mg, 0.013 mg, 80 mg, 25 mg, 20 mg, 0.15 mg
Drug class:
Active ingredients:
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Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Folyra

DESCRIPTION

Folyra is a prescription multivitamin/multimineral dietary supplement.

SUPPLEMENT FACTS

Serving size

Amount per serving:

1 tablet

% Daily Value

Vitamin A (as Beta-Carotene)300 mcg RAE33%
Vitamin C (as Ascorbic Acid)60mg67%
Vitamin D (as Cholecalciferol)10mcg50%
Vitamin E (as di-Alpha Tocopherol Acetate)4.5 mg (10 IU)33%
Vitamin 86 (as Pyrldoxine HCI)26mg1529%
Biotin0.280mg933%
Folate1.67 mg □FE418%
(from Folic Acid)0.67 mg □FE
(from 5 Methyl Tetrahydrotolate Calcium Salt)1 mg DFE
Vitamin 812 (as Cyanocobalamin)0.013 mg542%
Calcium (as Calcium Carbonate)80 mg6%
Magnesium (as Magnesium Oxide)25mg6%
Ferrochel""20mg111mg
Iodine (as Potassium Iodide)0.150mg100%
Other Ingredients: Microcrystalline Cellulose, Maltodextrin, Croscarmellose Sodium, Silcon Dioxide, Stearic Acid, Magnesium Stearate, FiIm Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue# 1

INDICATIONS AND USAGE

Folyra is a prescription multivitamin/multimineral dietary supplement indicated for the clinical dietary management of patients with suboptimal nutritional status requiring supplementation of folate and B vitamins, under physician supervision.

CONTRAINDICATIONS

Folyra 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 B12 deficiency is present. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

WARNINGS

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Call your doctor for medical advice about adverse reactions. To report suspected adverse reactions or obtain product information, contact Oncora Pharma at 888-321-2821.

DOSAGE AND ADMINISTRATION

One tablet orally once or twice daily or as directed by a physician.

HOW SUPPLIED

Folyra is supplied as tan, oblong tablets in bottles of 30 (NDC 85477-523-30).

STORAGE

STORAGE: Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid excessive heat, light, and moisture.

About this document

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

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Drug information for Folyra

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 Beta carotene 300 mcg, Ascorbic acid 60 mg, Cholecalciferol 10 mcg, Alpha-tocopherol acetate, DL- 4.5 mg, Pyridoxine hydrochloride 26 mg, Biotin 0.28 mg, Folic acid 1.67 mg, Cyanocobalamin 0.013 mg, Calcium carbonate 80 mg, Magnesium oxide 25 mg, Ferrous bisglycinate 20 mg, Potassium iodide 0.15 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
300 mcg, 60 mg, 10 mcg, 4.5 mg, 26 mg, 0.28 mg, 1.67 mg, 0.013 mg, 80 mg, 25 mg, 20 mg, 0.15 mg – 30 in 1 bottle NDC 85477-523-30

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.