MedPath

Prenatal Plus Vitamins

Prenatal Vitamins Plus Low Iron

Approved
Approval ID

1b8ef3ea-5563-48ef-ba5e-27e0b454efb9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 30, 2025

Manufacturers
FDA

REMEDYREPACK INC.

DUNS: 829572556

Products 1

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

prenatal with ferrous fumarate and folic acid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70518-4258
Product Classification
G
Generic Name
prenatal with ferrous fumarate and folic acid
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2025
FDA Product Classification

INGREDIENTS (25)

HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
VITAMIN A ACETATEActive
Quantity: 924 ug in 1 1
Code: 3LE3D9D6OY
Classification: ACTIM
BETA CAROTENEActive
Quantity: 276 ug in 1 1
Code: 01YAE03M7J
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 120 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 10 ug in 1 1
Code: 1C6V77QF41
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 10 mg in 1 1
Code: WR1WPI7EW8
Classification: ACTIM
THIAMINE MONONITRATEActive
Quantity: 1.84 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
RIBOFLAVINActive
Quantity: 3 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
NIACINAMIDEActive
Quantity: 20 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
FOLIC ACIDActive
Quantity: 1667 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 12 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
CALCIUM CARBONATEActive
Quantity: 200 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB
FERROUS FUMARATEActive
Quantity: 27 mg in 1 1
Code: R5L488RY0Q
Classification: ACTIM
ZINC OXIDEActive
Quantity: 25 mg in 1 1
Code: SOI2LOH54Z
Classification: ACTIB
CUPRIC OXIDEActive
Quantity: 2 mg in 1 1
Code: V1XJQ704R4
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/20/2025

DRUG: Prenatal Plus Vitamins

GENERIC: prenatal with ferrous fumarate and folic acid

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-4258-0

COLOR: brown

SHAPE: OVAL

SCORE: No score

SIZE: 9 mm

IMPRINT: P;5

PACKAGING: 100 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • Vitamin A Acetate 924ug in 1
  • Beta Carotene 276ug in 1
  • Ascorbic Acid 120mg in 1
  • Cholecalciferol 10ug in 1
  • .Alpha.-TocopheroL Acetate, DL- 10mg in 1
  • Thiamine Mononitrate 1.84mg in 1
  • Riboflavin 3mg in 1
  • Niacinamide 20mg in 1
  • Pyridoxine Hydrochloride 10mg in 1
  • Folic Acid 1667ug in 1
  • Cyanocobalamin 12ug in 1
  • Calcium Carbonate 200mg in 1
  • Ferrous Fumarate 27mg in 1
  • Zinc Oxide 25mg in 1
  • Cupric Oxide 2mg in 1

INACTIVE INGREDIENT(S):

  • Hypromellose, Unspecified
  • Magnesium Stearate
  • Maltodextrin
  • Microcrystalline Cellulose
  • Polyethylene Glycol 400
  • Stearic Acid
  • Titanium Dioxide
  • FD&C Blue NO. 2
  • FD&C Red NO. 40
  • FD&C Yellow NO. 6

MM1

BOXED WARNING SECTION

LOINC: 34066-1Updated: 1/20/2025

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. Keep this product out of the reach of children. In case of accidental overdose, call a Physician or Poison Control Center immediately.

DESCRIPTION SECTION

LOINC: 34089-3Updated: 1/20/2025

Description

Prenatal Plus Vitamins is a prescription folic acid containing dietary vitamin and mineral supplement for women before, during and after pregnancy.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/20/2025

Directions

Use before, during and after pregnancy under the supervision of a medical professional. One tablet daily or as prescribed.

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 1/20/2025

Caution

Folic acid may partially correct the hematological damage due to Vitamin B-12 deficiency of pernicious anemia while the associated neurological damage progresses.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 1/20/2025

Storage

Store at room temperature, USP.**Protect from light and moisture.**Dispense in a tight, light-resistant container. Contact with moisture may discolor or erode tablets.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 1/20/2025

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

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