FDA.reportPublic FDA data

CHOLECALCIFEROL (VITAMIN D3) 1.25 mg TABLETS (50,000 Units)

Manufacturer
Nnodum Pharmaceuticals
Effective date
2021-06-21
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 22:42:53

Label at a glance#

ProductPrenatal Vitamins Plus
Active ingredientVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, COPPER
Label structure10 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Product Labeling

DESCRIPTION SECTION

Supplemental Facts 
Each tablet Contains: Amount per Tablet % Daily Value
 Vitamin A (as Acetate and 23% Beta Carotene) 1200 mcg   92%
 Vitamin C (as Ascorbic acid)    120 mg       100%
 Vitamin D3 (as Cholecalciferol)      10 mcg  67%
 Vitamin E (as di-Alpha Tocopheryl Acetate)      10 mg   53%
 Vitamin B1 (as Thiamine Mononitrate)   1.84 mg 131%
 Vitamin B2 (as Riboflavin)        3 mg 188%
 Niacin (as Niacinaminde)      20 mg 111%
 Vitamin B6 (as Pyridoxine HCL)      10 mg 500%
 Folate DFE (400 mcg Folic Acid)1,700 mcg 283%
 Vitamin B12 (as Cyanocobalamin)    12 mcg 429%
 Calcium (as Calcium Carbonate)   200 mg   15%
 Iron (as Ferrous Fumarate)     27 mg 100%
 Zinc (as Zinc Oxide)     25 mg 192%
 Copper (as Cupric Oxide)       2 mg 154%

Other Ingredients:

INACTIVE INGREDIENT SECTION

Microcrystalline Cellulose, Stearic Acid, Croscarmellose Sodium, Gelatin, Acacia, Maltodextrin, Silica, Talc, Titanium Dioxide, Vegetable Magnesium Stearate, Polyethylene Glycol, Starch, Polyvinylpyrrolidone, Sucrose, Dicalcium Phosphate, Ethyl Vanillin, FD&C Yellow #6 Lake, Sodium Ascorbate, Glucose, Triglycerides, Tocopherols, Sodium Benzoate, FD&C Blue #2 Lake, BHT, FD&C Red #40 Lake and Sorbic Acid.

Directions:

DOSAGE & ADMINISTRATION SECTION

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

Caution:

GENERAL PRECAUTIONS SECTION

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

Warning:

WARNINGS SECTION

Accidental overdose of iron-containing products is a leading cause of fetal poisoning in children under six.

KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

In case of acciential overdose, call a physician or Poison Control Center immediately.

Indications:

INDICATIONS & USAGE SECTION

To promote 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.

Contraindications:

CONTRAINDICATIONS SECTION

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

Storage:

STORAGE AND HANDLING SECTION

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

Safety Information:

OTHER SAFETY INFORMATION

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

Prenatal Vitamins PlusLow Iron Tablets product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

63044-150-01

Prenatal Vitamins Plus
Low Iron Tablets

Vitamins and Mineral
Supplement for pregnant
& lactating women

ZIKS Nnodum Pharmaceuticals

100 Tablets

Manufactured for: Nnodum Pharmaceuticals
Cincinnati, OH 45240 (513) 861-2329
MADE IN THE USA

100 Tab Bottle

150-01 100 ct150-01 100 ct

500 tab Bottle

150-05 500 ct150-05 500 ct

res

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63044-150-012021-03-05C16284748780-1ba0f9c33-5375-a910-e053-dadaa90a0b85CHOLECALCIFEROL (VITAMIN D3) 1.25 mg TABLETS (50,000 Units)
63044-150-052021-03-05C16284748780-1ba0f9c33-5375-a910-e053-dadaa90a0b85CHOLECALCIFEROL (VITAMIN D3) 1.25 mg TABLETS (50,000 Units)
63044-150-012021-01-29C16284748780-1ba0f9c33-5375-a910-e053-dadaa90a0b85CHOLECALCIFEROL (VITAMIN D3) 1.25 mg TABLETS (50,000 Units)
63044-150-052021-01-29C16284748780-1ba0f9c33-5375-a910-e053-dadaa90a0b85CHOLECALCIFEROL (VITAMIN D3) 1.25 mg TABLETS (50,000 Units)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63044-150-01EA - Each63044-1504d36a801-8e94-49b3-a822-36037880b2b212016-04-04
63044-150-05EA - Each63044-150c84772a5-5543-4b40-b0dd-df57d392d52812016-07-19

Products#

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

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63044-15063044-150-01, 63044-150-05

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
VITAMIN A ACETATE3LE3D9D6OYACTIM
ASCORBIC ACIDPQ6CK8PD0RACTIB
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0ACTIB
THIAMINE MONONITRATE8K0I04919XACTIR
RIBOFLAVINTLM2976OFRACTIB
NIACINAMIDE25X51I8RD4ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIM
FOLIC ACID935E97BOY8ACTIB
CYANOCOBALAMINP6YC3EG204ACTIB
CALCIUM CARBONATEH0G9379FGKACTIB
FERROUS FUMARATER5L488RY0QACTIM
ZINC OXIDESOI2LOH54ZACTIB
COPPER789U1901C5ACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
GELATIN2G86QN327LIACT
ACACIA5C5403N26OIACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STARCH, CORNO8232NY3SJIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SUCROSEC151H8M554IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
ETHYL VANILLINYC9ST449YJIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
SODIUM ASCORBATES033EH8359IACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM BENZOATEOJ245FE5EUIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
FD&C RED NO. 40WZB9127XOAIACT
SORBIC ACIDX045WJ989BIACT

Source Document#

Source XML · Source PDF

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
bb10cef4-a862-4fe9-8f0f-851e74ba6748161f0d6c-a272-42d9-bd04-576e6065b2342021-10-19WarningsExact identifier
spl set id: 161f0d6c-a272-42d9-bd04-576e6065b234

Reported adverse events (FAERS/openFDA)#

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