FOLARTEX- multivitamin tablet

Folartex by

Drug Labeling and Warnings

Folartex by is a Prescription medication manufactured, distributed, or labeled by Oncora Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Folarex

DESCRIPTION

Folarex is a prescription multivitamin/multimineral dietary supplement.

SUPPLEMENT FACTS
Servingsize; Amount per serving:		1tablet; % Daily Value
Vitamin A (as Beta-Carotene)	300 mcg RAE	33%
Vitamin C (as Ascorbic Acid)	60mg	67%
Vitamin D (as Cholecalciferol)	10mcg	50%
Vitamin E (as di-Alpha Tocopherol Acetate)	4.5 mg (10 IU)	33%
Vitamin 86 (as Pyrldoxine HCI)	26mg	1529%
Biotin	0.280mg	933%
Folate	1.67 mg DFE	418%
(from Folic Acid)	0.67 mg DFE
(from 5 Methyl Tetrahydrotolate Calcium Salt)	1 mg DFE
Vitamin 812 (as Cyanocobalamin)	0.013 mg	542%
Calcium (as Calcium Carbonate)	80 mg	6%
Magnesium (as Magnesium Oxide)	25mg	6%
Ferrochel""	20mg	111mg
Iodine (as Potassium Iodide)	0.150mg	100%

Other Ingredients: Microcrysta line Ce lulose, Maltodextrin, Croscarme lose Sodium, Silcon Dioxide, Stearic Acid, Magnesium Stearate, FiIm Coating (Hydroxypropyl Methylce lulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue# 1

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

Folarex 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

WARNING Accidental overdose of iron-containing products is a leading cause of fatal poising in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In the case of accidental overdose, ca l a doctor or poison control center immediately.

ADVERSE REACTIONS

Allergic sensitization has been reported fo lowing both oral and parenteral administration of folic acid. You should ca l 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.

DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

HOW SUPPLIED

Bottles of 30 Tablets (85477-901-30). Tablet is tan, oblong.

STORAGE

STORAGE: Store at 20- 25 degree C (68-77 F) excersions permitted to 15-30 degree C (59-86 F) {See USP contro led 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 Da las, TX 75161

PRINCIPAL DISPLAY PANEL

85477-511-30
Folarex
MULTIVITAMIN
30 TABLETS

Oncora Pharma, LLC

INGREDIENTS AND APPEARANCE

FOLARTEX 
multivitamin tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 85477-511
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J)	BETA CAROTENE	300 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	60 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	10 ug
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	4.5 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	26 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	0.28 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1.67 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	0.013 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	80 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	25 mg
FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	20 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	POTASSIUM IODIDE	0.15 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	brown (tan)	Score	no score
Shape	OVAL (Oblong)	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85477-511-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/23/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/23/2026

Labeler - Oncora Pharma, LLC (119482542)