MedPath

Vitrexyl

Vitrexyl Multivitamin Rx Only

Approved
Approval ID

ae064a9e-daba-fa86-e053-2a95a90a16a7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 11, 2023

Manufacturers
FDA

PureTek Corporation

DUNS: 785961046

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Folic Acid

PRODUCT DETAILS

NDC Product Code59088-164
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateJanuary 11, 2023
Generic NameFolic Acid

INGREDIENTS (26)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CHROMIUM NICOTINATEActive
Quantity: 35 ug in 1 1
Code: A150AY412V
Classification: ACTIB
COCOAInactive
Code: D9108TZ9KG
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SELENIUMActive
Quantity: 55 ug in 1 1
Code: H6241UJ22B
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 120 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
FOLIC ACIDActive
Quantity: 1000 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 8 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
VITAMIN A ACETATEActive
Quantity: 1500 ug in 1 1
Code: 3LE3D9D6OY
Classification: ACTIM
THIAMINE MONONITRATEActive
Quantity: 3 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MAGNESIUM OXIDEActive
Quantity: 200 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
MOLYBDENUMActive
Quantity: 45 ug in 1 1
Code: 81AH48963U
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 20 ug in 1 1
Code: 1C6V77QF41
Classification: ACTIB
RIBOFLAVINActive
Quantity: 3.4 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
NIACINAMIDEActive
Quantity: 20 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
CALCIUM CARBONATEActive
Quantity: 200 mg in 1 1
Code: H0G9379FGK
Classification: ACTIM
ZINC OXIDEActive
Quantity: 25 mg in 1 1
Code: SOI2LOH54Z
Classification: ACTIM
MANGANESE SULFATEActive
Quantity: 2.3 mg in 1 1
Code: W00LYS4T26
Classification: ACTIM
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 30 mg in 1 1
Code: WR1WPI7EW8
Classification: ACTIM

Drug Labeling Information

CONTRAINDICATIONS SECTION

LOINC: 34070-3Updated: 8/29/2020

CONTRAINDICATIONS:

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

WARNINGS SECTION

LOINC: 34071-1Updated: 8/29/2020

WARNING:

Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

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