Prenatal Plus Iron Tablets

Manufacturer
Nationwide Laboratories
Effective date
2020-03-04
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:39:30

Label at a glance#

ProductPrenatal Plus
Active ingredientVitamin A, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Iron, Zinc Oxide, Cupric Oxide
Label structure9 sections

Boxed warning

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

Storage and handling

Store at room temperature. Dispense in a well closed light-resistant container, with a child resistant cap.

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Each Tablet Contains:
VITAMINS:
Amount per Tablet
Vitamin A (from Acetate and Beta Carotene)4000 IU
Vitamin C (Ascorbic Acid)120 mg
Vitamin D-3 (Cholecalciferol)400 IU
Vitamin E (dl-Alpha Tocopheryl Acetate)22 IU
Thiamine (Vitamin B-1 from Thiamine Mononitrate)1.84 mg
Riboflavin (Vitamin B-2)3 mg
Niacin (as Niacinamide)20 mg
Vitamin B-6 (from Pyridoxine HCl)10 mg
Folic Acid1 mg
Vitamin B-12 (Cyanocobalamin)12 mcg
MINERALS:
Calcium (from Calcium Carbonate)200 mg
Iron (from Carbonyl Iron)29 mg
Zinc (from Zinc Oxide)25 mg
Copper (from Cupric Oxide)2 mg

Other Ingredients

SPL UNCLASSIFIED SECTION

Ascorbyl Palmitate, Citric Acid anhydrous, DL- alpha Tocopherol, Ethylcellulose, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #5 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.

Indication

INDICATIONS & USAGE SECTION

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

Dosage

DOSAGE & ADMINISTRATION SECTION

As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by physician.

WARNING

BOXED WARNING SECTION

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

Precautions

PRECAUTIONS SECTION

Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

STORAGE AND HANDLING SECTION

Store at room temperature. Dispense in a well closed light-resistant container, with a child resistant cap.

SPL UNCLASSIFIED SECTION

CALL YOUR DOCTOR FOR MEDICAL ADVISE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 (TOLL FREE).

Keep this and all medication out of the reach of children.

Do not use if imprinted Safety Seal under cap is broken or missing.

Distributed by: Nationwide Laboratories, Iselin NJ 08830

Lot No.: Exp. Date: Rev. 7/12

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nationwide Laboratories LLC

NDC 42937-705-10

Prenatal Plus
Iron Tablets

Multivitamin/Multimineral
Supplement

For Use Before, During
and After Pregnancy.

Rx only

100 Tablets

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42937-705-10EA - Each42937-7057132f39d-5b1b-4285-987d-99a91549abbe12015-08-04
42937-705-16EA - Each42937-70577862f06-e2e7-458c-a7e6-6369ee1d23f912015-08-04
42937-705-18EA - Each42937-705343b0d3d-584c-4022-b31b-2801c2c5eb9e12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.Alpha.-Tocopherol Acetate, Dl-ACTIVE INGREDIENTWR1WPI7EW81
Ascorbic AcidACTIVE INGREDIENTPQ6CK8PD0R1
Calcium CarbonateACTIVE INGREDIENTH0G9379FGK1
CholecalciferolACTIVE INGREDIENT1C6V77QF411
Cupric OxideACTIVE INGREDIENTV1XJQ704R41
CyanocobalaminACTIVE INGREDIENTP6YC3EG2041
Folic AcidACTIVE INGREDIENT935E97BOY81
IronACTIVE INGREDIENTE1UOL152H71
NiacinamideACTIVE INGREDIENT25X51I8RD41
Pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BV1
RiboflavinACTIVE INGREDIENTTLM2976OFR1
Thiamine MononitrateACTIVE INGREDIENT8K0I04919X1
Vitamin AACTIVE INGREDIENT81G40H8B0T1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
.Alpha.-Tocopherol, Dl-ACTIVE MOIETY7QWA1RIO011
Ascorbic AcidACTIVE MOIETYPQ6CK8PD0R1
Carbonate IonACTIVE MOIETY7UJQ5OPE7D1
CholecalciferolACTIVE MOIETY1C6V77QF411
Cupric CationACTIVE MOIETY8CBV67279L1
CyanocobalaminACTIVE MOIETYP6YC3EG2041
Folic AcidACTIVE MOIETY935E97BOY81
IronACTIVE MOIETYE1UOL152H71
NiacinamideACTIVE MOIETY25X51I8RD41
PyridoxineACTIVE MOIETYKV2JZ1BI6Z1
RiboflavinACTIVE MOIETYTLM2976OFR1
Thiamine IonACTIVE MOIETY4ABT0J945J1
Vitamin AACTIVE MOIETY81G40H8B0T1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
.Alpha.-Tocopherol, Dl-INACTIVE INGREDIENT7QWA1RIO011
AcaciaINACTIVE INGREDIENT5C5403N26O1
Aluminum OxideINACTIVE INGREDIENTLMI26O69331
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSL1
Ascorbyl PalmitateINACTIVE INGREDIENTQN83US2B0N1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61U1
DextroseINACTIVE INGREDIENTIY9XDZ35W21
EthylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4B1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQK1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOA1
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1M1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A81
HypromellosesINACTIVE INGREDIENT3NXW29V3WO1
Magnesium StearateINACTIVE INGREDIENT70097M6I301
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2D1
Mineral OilINACTIVE INGREDIENTT5L8T28FGP1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1A1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU41
Sorbic AcidINACTIVE INGREDIENTX045WJ989B1
Soy ProteinINACTIVE INGREDIENTR44IWB3RN51
Starch, CornINACTIVE INGREDIENTO8232NY3SJ1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP1
SucroseINACTIVE INGREDIENTC151H8M5541
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JP1
Tricalcium PhosphateINACTIVE INGREDIENTK4C08XP6661

Products#

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

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42937-70542937-705-10, 42937-705-16, 42937-705-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 10 · 572 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Magnesium StearateMAGNESIUM STEARATE70097M6I30SUSPENSION, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
39 equally ranked IID candidates
Sorbic AcidSORBIC ACIDX045WJ989BSOLUTION / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii candidate
28 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
26 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED, EXTENDED RELEASE / ORAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
26 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30WAFER / ORAL66 mgExact identifier — unii candidate
39 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOGEL / RECTAL348 mgExact identifier — unii candidate
27 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE1 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOAELIXIR / ORAL12.5 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MLIQUID / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLCONCENTRATE / ORAL84 mgExact identifier — unii candidate
61 equally ranked IID candidates
AcaciaACACIA5C5403N26OPOWDER, FOR SUSPENSION / ORAL7386 mgExact identifier — unii candidate
19 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii candidate
28 equally ranked IID candidates
DextroseDEXTROSEIY9XDZ35W2INJECTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
SucroseSUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii candidate
48 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NSOLUTION / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSOAP / TOPICAL1 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
DextroseDEXTROSEIY9XDZ35W2INJECTION, SOLUTION / INTRATHECAL1925 mgExact identifier — unii candidate
21 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED / ORAL0.03 mgExact identifier — unii candidate
34 equally ranked IID candidates
DextroseDEXTROSEIY9XDZ35W2POWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
26 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJSUSPENSION/ DROPS / ORAL90 mgExact identifier — unii candidate
22 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii candidate
26 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOATABLET, COATED / ORAL0.1 mgExact identifier — unii candidate
28 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MaltodextrinMALTODEXTRIN7CVR7L4A2DTABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
15 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8SUSPENSION / ORAL11 mgExact identifier — unii candidate
34 equally ranked IID candidates
DextroseDEXTROSEIY9XDZ35W2LOZENGE / BUCCALNAExact identifier — unii candidate
21 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / INTRAVENOUS772 mgExact identifier — unii candidate
61 equally ranked IID candidates
SucroseSUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii candidate
61 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APPELLET / SUBCUTANEOUS0.97 mgExact identifier — unii candidate
26 equally ranked IID candidates
SucroseSUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C Blue No. 2FD&C BLUE NO. 2L06K8R7DQKTABLET / ORAL25 mgExact identifier — unii candidate
11 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
Aluminum OxideALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
EthylcellulosesETHYLCELLULOSE7Z8S9VYZ4BCREAM / TOPICALNAExact identifier — unii candidate
14 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLELIXIR / ORAL90 mgExact identifier — unii candidate
61 equally ranked IID candidates
SucroseSUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APPOWDER, FOR SUSPENSION / ORAL1203 mg/5mlExact identifier — unii candidate
26 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
Sorbic AcidSORBIC ACIDX045WJ989BTABLET, FILM COATED, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INFILTRATION0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii candidate
22 equally ranked IID candidates
Mineral OilMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
AcaciaACACIA5C5403N26OSUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
19 equally ranked IID candidates
MaltodextrinMALTODEXTRIN7CVR7L4A2DLOZENGE / ORAL175 mgExact identifier — unii candidate
15 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii candidate
39 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SUSPENSION / ORAL4441 mgExact identifier — unii candidate
28 equally ranked IID candidates
Anhydrous Citric AcidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / SUBCUTANEOUS25 mgExact identifier — unii candidate
61 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii candidate
39 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1576 mgExact identifier — unii candidate
28 equally ranked IID candidates

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
57f24071-e4ec-4da9-837b-a5acaceb2fc7d358a991-e17a-47ff-beeb-8ef0aea569442021-12-20Boxed warningExact identifier
spl set id: d358a991-e17a-47ff-beeb-8ef0aea56944

Reported adverse events (FAERS/openFDA)#

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