Prenatal Vitamins Plus Low Iron

Manufacturer
REMEDYREPACK INC.
Effective date
2026-04-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:16:18

Label at a glance#

ProductPrenatal Plus Vitamins
Active ingredientVITAMIN A ACETATE, BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE
Label structure8 sections

Boxed 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.

Dosage and administration

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

Storage and handling

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.

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Supplement Facts
Serving Size: 1 TabletAmount per Serving% Daily Value *
Vitamin A1200 mcg92%
(Acetate and Beta Carotene)RAE
Vitamin C (Ascorbic Acid)120 mg100%
Vitamin D-3 (Cholecalciferol)10 mcg67%
Vitamin E (dl-α Tocopheryl Acetate)10 mg53%
Vitamin B-1 (Thiamine Mononitrate)1.84 mg131%
Vitamin B-2 (Riboflavin)3 mg188%
Niacin (Niacinamide)20 mg111%
Vitamin B-6 (Pyridoxine HCl)10 mg500%
Folic Acid1667 mcg278%
DFE (1 mg)
Vitamin B-12 (Cyanocobalamin)12 mcg429%
Calcium (Calcium Carbonate)200 mg15%
Iron (Ferrous Fumarate)27 mg100%
Zinc (Zinc Oxide)25 mg192%
Copper(Cupric Oxide)2 mg154%

* Daily Value is for Pregnant and Lactating Women

Other Ingredients:Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Stearic Acid, Titanium Dioxide, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #6 lake

Description

DESCRIPTION SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Caution

PRECAUTIONS SECTION

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

WARNING

BOXED WARNING SECTION

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.

Storage

STORAGE AND HANDLING SECTION

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

Repackaged and Distributed By:

Remedy Repack, Inc.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Prenatal Plus Vitamins

GENERIC: prenatal with ferrous fumarate and folic acid

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-4258-0

NDC: 70518-4258-1
NDC: 70518-4258-2

COLOR: brown

SHAPE: OVAL

SCORE: No score

SIZE: 9 mm

IMPRINT: P;5

PACKAGING: 100 in 1 BOTTLE, PLASTIC

PACKAGING: 50 in 1 BOX

PACKAGING: 1 in 1 POUCH

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

MM1MM1

MM2MM2

MM3MM3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4258-0Prenatal Plus Vitamins100 in 1 BOTTLE, PLASTICTABLET1003
70518-4258-1Prenatal Plus Vitamins50 in 1 BOXTABLET503
70518-4258-2Prenatal Plus Vitamins1 in 1 POUCHTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39328-106-10EA - Each39328-106f7a4b752-043d-4e8c-9e22-562606df749812013-07-02
39328-106-50EA - Each39328-106ad2ea590-9335-491b-af0b-28c3b864f77912014-04-03

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-425870518-4258-0, 70518-4258-2, 70518-4258-1
39328-106

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prenatal Plus VitaminsPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDREMEDYREPACK INC.1b8ef3ea-5563-48ef-ba5e-27e0b454efb92026-04-23Boxed warningExact identifier
ndc (package): 70518-4258-2
ndc (package): 70518-4258-0
ndc (package): 70518-4258-1
ndc (product): 70518-4258
ndc11 (package): 70518425802
ndc11 (package): 70518425800
ndc11 (package): 70518425801
spl id: 502002a4-9248-5370-e063-6394a90a9717
spl set id: 1b8ef3ea-5563-48ef-ba5e-27e0b454efb9
Prenatal Plus VitaminsPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDPatrin Pharma, Inc.59c5c1a4-3f42-441a-b842-903f9bab346f2022-01-13Boxed warningExact identifier
ndc (product): 39328-106

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.