FDA.reportPublic FDA data

PRENATAL VITAMINS PLUS LOW IRON TABLETS

Manufacturer
REMEDYREPACK INC.
Effective date
2020-09-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:13:56

Label at a glance#

ProductPrenatal Vitamins Plus Low Iron
Active ingredientVITAMIN A ACETATE, BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, IRON, ZINC, COPPER
Label structure10 sections

Boxed warning

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Storage and handling

Store at room temperature, USP. Dispense in a well closed light resistant container. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Label contents#

Full prescribing information#

BOXED WARNING SECTION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DESCRIPTION SECTION

Each Tablet Contains:Amount
Per Tablet 		% Daily
Value
Vitamin A (from Acetate and Beta Carotene)4000 IU80%
Vitamin C (Ascorbic Acid)120 mg200%
Vitamin D-3 (Cholecalciferol)400 IU100%
Vitamin E (dl-Alpha Tocopheryl Acetate)22 mg73%
Vitamin B-1(Thiamine Mononitrate)1.84 mg123%
Vitamin B-2 (Riboflavin)3 mg176%
Niacin (as Niacinamide)20 mg100%
Vitamin B-6 (Pyridoxine HCI)10 mg500%
Folic Acid1 mg200%
Vitamin B-12 (Cyanocobalamin)12 mcg200%
Calcium (from Calcium Carbonate)200 mg20%
Iron (Ferrous Fumarate)27 mg150%
Zinc (Zinc Oxide)25mg167%
Copper (Cupric Oxide)2 mg100%

Other Ingredients: Ascorbyl Palmitate, Citric Acid anhydrous, DL- alpha Tocopherol, Ethylcellulose, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #6 lake, Glucose, Gum Acacia, Hypromellose, Magnesium Stearate, Maize Starch, Maltodextrin, Methylcellulose, Microcrystalline Cellulose, Mineral Oil, Mono and di-glycerides, Polyethylene Glycol, Pregelatinzed Corn Starch, Silicon Dioxide, Sorbic Acid, Soy Protein, Stearic Acid, Sucrose, Titanium Dioxide, Tricalcium Phosphate.

INDICATIONS & USAGE SECTION

Indications: To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and nonlactating mother. It is also useful for improving nutritional status prior to conception.

DOSAGE & ADMINISTRATION SECTION

Directions: Before, during and after pregnancy, one tablet daily or as directed by a physician.

CONTRAINDICATIONS SECTION

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

PRECAUTIONS SECTION

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

BOXED WARNING SECTION

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a physician or Poison Control Center immediately.

STORAGE AND HANDLING SECTION

Store at room temperature, USP. Dispense in a well closed light resistant container.

Repackaged and Distributed By:

Remedy Repack, Inc.

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

HOW SUPPLIED SECTION

NDC: 70518-2746-00

PACKAGING: 30 in 1 BLISTER PACK

Store at room temperature, USP. Dispense in a well closed light resistant container.

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 Vitamins Plus Low Iron

GENERIC: Prenatal with Ferrous Fum and Folic Acid

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2746-0

COLOR: brown

SHAPE: OVAL

SCORE: No score

SIZE: 9 mm

IMPRINT: P;5

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • VITAMIN A ACETATE 3080[iU] in 1
  • BETA CAROTENE 920[iU] in 1
  • ASCORBIC ACID 120mg in 1
  • CHOLECALCIFEROL 400[iU] in 1
  • .ALPHA.-TOCOPHEROL ACETATE, DL- 22mg in 1
  • THIAMINE 1.84mg in 1
  • RIBOFLAVIN 3mg in 1
  • NIACIN 20mg in 1
  • PYRIDOXINE HYDROCHLORIDE 10mg in 1
  • FOLIC ACID 1mg in 1
  • CYANOCOBALAMIN 12ug in 1
  • CALCIUM CARBONATE 200mg in 1
  • IRON 27mg in 1
  • ZINC 25mg in 1
  • COPPER 2mg in 1

INACTIVE INGREDIENT(S):

  • TRICALCIUM PHOSPHATE
  • SUCROSE
  • STEARIC ACID
  • SOY PROTEIN
  • SORBIC ACID
  • SILICON DIOXIDE
  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • GLYCERYL MONOSTEARATE
  • MINERAL OIL
  • MICROCRYSTALLINE CELLULOSE
  • METHYLCELLULOSE (100 MPA.S)
  • TITANIUM DIOXIDE
  • MALTODEXTRIN
  • MAGNESIUM STEARATE
  • HYPROMELLOSE, UNSPECIFIED
  • ACACIA
  • DEXTROSE, UNSPECIFIED FORM
  • FD&C YELLOW NO. 6
  • FD&C RED NO. 40
  • FD&C BLUE NO. 2
  • ETHYLCELLULOSE, UNSPECIFIED
  • .ALPHA.-TOCOPHEROL, DL-
  • ANHYDROUS CITRIC ACID
  • STARCH, CORN
  • ASCORBYL PALMITATE

MM1MM1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2746-02025-11-26C16284748780-1d6a99b39-e396-a426-e053-dadaa90af4c2PRENATAL VITAMINS PLUS LOW IRON TABLETS
70518-2746-02022-01-28C16284748780-1d6a99b39-e396-a426-e053-dadaa90af4c2PRENATAL VITAMINS PLUS LOW IRON TABLETS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2746PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [REMEDYREPACK INC.]2Legacy NDC20200929_d07d9ae1-65a9-43f6-af84-896c0e7f7d69.zip

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 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-274670518-2746-0
39328-106

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASCORBYL PALMITATEQN83US2B0NIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
ACACIA5C5403N26OIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
STARCH, CORNO8232NY3SJIACT
MALTODEXTRIN7CVR7L4A2DIACT
METHYLCELLULOSE (100 MPA.S)4GFU244C4JIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SORBIC ACIDX045WJ989BIACT
SOY PROTEINR44IWB3RN5IACT
STEARIC ACID4ELV7Z65APIACT
SUCROSEC151H8M554IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
VITAMIN A ACETATE3LE3D9D6OYACTIM
BETA CAROTENE01YAE03M7JACTIB
ASCORBIC ACIDPQ6CK8PD0RACTIB
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8ACTIM
THIAMINEX66NSO3N35ACTIB
RIBOFLAVINTLM2976OFRACTIB
NIACIN2679MF687AACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIB
FOLIC ACID935E97BOY8ACTIB
CYANOCOBALAMINP6YC3EG204ACTIB
CALCIUM CARBONATEH0G9379FGKACTIB
IRONE1UOL152H7ACTIB
ZINCJ41CSQ7QDSACTIB
COPPER789U1901C5ACTIB

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
d6e7f8ed-9af8-102c-e053-2995a90a1e57d07d9ae1-65a9-43f6-af84-896c0e7f7d692024-06-21Boxed warningExact identifier
spl set id: d07d9ae1-65a9-43f6-af84-896c0e7f7d69
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.