Prenatal Plus Iron Tablets

Manufacturer
Blenheim Pharmacal, Inc.
Effective date
2016-01-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:21:50

Label at a glance#

ProductPRENATAL PLUS IRON
Active ingredientVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, IRON PENTACARBONYL, ZINC OXIDE, CUPRIC OXIDE
Label structure7 sections

Boxed warning

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

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

DESCRIPTION SECTION

Prenatal Plus Iron Tablet is caplet shaped, film coated tablet debossed CIS 28, and provides 10 vitamins and 4 minerals to supplement the diet before, during and after pregnancy.

Each Prenatal Plus tablet Contains:

Vitamin A (Acetate and Beta Carotene)............................................4000 I.U.

Vitamin C (Ascorbic acid)..................................................................120 mg

Vitamin D-3 (Cholecalciferol)...............................................................400 I.U.

Vitamin E (dl- Alpha Tocopheryl Acetate)...........................................22 I.U.

Thiamine (Vitamin B-1 from Thiamine Mononitrate...............................1.84 mg

Riboflavin (Vitamin B-2).......................................................................3 mg

Niacin(Niacinamide).............................................................................20 mg

Vitamin B-6 (Pyridoxine HCl)...............................................................10 mg

Folic Acid.............................................................................................1 mg

Vitamin B-12 (Cyanocobalamin)..........................................................12 mcg

Calcium (Calcium Carbonate)...............................................................200 mg

Iron (Carbonyl Iron)..............................................................................29 mg

Zinc (Zinc Oxide).................................................................................25 mg

Copper (Cupric Oxide)..........................................................................2 mg

Other ingredients: 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 Yello # 6 lake, Glucose, Gum Acacia, Hypromellose, Magnesium Stearate, Maize Starch, Maltodextrin, Methylcellulose, Microcrystalline Cellulose, Mineral Oil, Mono-and di-glycerides, Polyethyelene Glycol, Pregelatinized Corn Starch, Silicon Dioxide, Sorbic Acid, Soy Protein, Stearic Acid, Sucrose, Titanium Dioxide, Tricalcium Phosphate

INDICATIONS

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 a physician.

WARNING

BOXED WARNING SECTION

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.

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

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 Yello No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

STORAGE

STORAGE AND HANDLING SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

NDC 0904-5339-60 plastic bottle containing 100 Tablets.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prenatal Plus Iron Tablets (Multivitamin/Multimineral Supplement)
31 Tabets
10544-609-31

Prenatal Plus Iron TabletsPrenatal Plus Iron Tablets

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
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91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-609-312020-01-31C16284748780-19d75b9d0-26f2-f424-e053-dadaa90a57cePrenatal Plus Iron Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-609-31PRENATAL PLUS IRON31 in 1 BOTTLE, PLASTICTABLET, FILM COATED311

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-609PRENATAL PLUS IRON (MULTIVITAMIN/MULTIMINERAL SUPPLEMENT) TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20160113_1af224e5-440b-4376-bcb6-625563a4bf29.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-609-31EA - Each10544-609b5149af6-fb8b-490c-a1b3-5e6c4504b8e112016-01-13
0904-5339-60EA - Each0904-533985a70a62-1869-444c-ac47-a7a7b83bc66c12012-07-24

Products#

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

DailyMed product names page 1 of 2 · 52 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10544-60910544-609-31
0904-5339

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ed4145ff-111d-4248-a490-3bed1c24005c1af224e5-440b-4376-bcb6-625563a4bf292016-01-12Boxed warningExact identifier
spl id: ed4145ff-111d-4248-a490-3bed1c24005c
spl set id: 1af224e5-440b-4376-bcb6-625563a4bf29

Reported adverse events (FAERS/openFDA)#

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