FDA.reportPublic FDA data

Prenatal Tablets

Manufacturer
Central Texas Community Health Centers | Major Pharmaceuticals
Effective date
2017-09-15
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:48:36

Label at a glance#

ProductPrenatal
Active ingredientVitamin A, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic acid, Cyanocobalamin, Calcium, Ferrous fumarate, Zinc oxide
Label structure7 sections

Dosage and administration

For adults, take one (1) tablet daily, preferably with a meal. As a reminder, discuss the supplements and medications you take with your health care providers.

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Supplement Facts
Serving Size: 1 Tablet
Amount Per Serving% Daily Value*
Vitamin A (as Acetate and Beta Carotene)4000 I.U.50%
Vitamin C (as Ascorbic Acid)100 mg.167%
Vitamin D-3 (as Cholecalciferol)400 I.U.100%
Vitamin E (as dl-Alpha Tocopheryl Acetate)11 I.U.37%
Vitamin B-1 (as Thiamine Mononitrate)1.5 mg.88%
Vitamin B-2 (Riboflavin)1.7 mg.85%
Vitamin B-3 (as Niacinamide)18 mg.90%
Vitamin B-6 (as Pyridoxine HCl)2.6 mg.104%
Folic Acid0.8 mg.100%
Vitamin B-12 (as Cyanocobalamin)4 mcg.50%
Calcium (as Calcium Carbonate and Calcium Sulfate)263 mg.26%
Iron (as Ferrous Fumarate)27 mg.150%
Zinc (as Zinc Oxide)25 mg.167%

* % Daily Value for Pregnant and Lactating Women

OTHER INGREDIENTS: Microcrystalline Cellulose, Stearic Acid, Hypromellose, Croscarmellose Sodium, Gelatin, Acacia, Maltodextrin, Titanium Dioxide, Talc, Triacetin, Starch, Magnesium Stearate, Dicalcium Phosphate, Mineral Oil, Sucrose, Silica, Sodium Ascorbate, Triglycerides, FD&C Red #40 Lake, FD&C Yellow #6 Lake, Tocopherols, Sodium Benzoate, Sorbic Acid, Tricalcium Phosphate, BHT and Ascorbyl Palmitate.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

For adults, take one (1) tablet daily, preferably with a meal. As a reminder, discuss the supplements and medications you take with your health care providers.

WARNING

WARNINGS SECTION

If you are pregnant, nursing, taking any medications or planning any medical procedure, consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occur.

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 doctor or Poison Control Center immediately.

FREE OF

HEALTH CLAIM SECTION

Yeast, wheat, milk or milk derivatives, soy, artificial flavor, sodium (less than 5 mg per serving).

HEALTH CLAIM SECTION

STORE AT ROOM TEMPERATURE AND AVOID EXCESSIVE HEAT. TAMPER RESISTANT: DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.

HEALTH CLAIM SECTION

Distributed by: MAJOR® PHARMACEUTICALS
31778 Enterprise Drive, Livonia, MI 48150, USA
Questions or Comments? (800) 616-2471

M-29
Rev. 03/16
7434-03-16

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CommUnityCare Federally Qualified Health Centers

PRENATAL
VITAMINS
# 100

Date:

Name:
Dr.

TAKE 1 TABLET DAILY AS DIRECTED BY PHYSICIAN.

01/01/01

123456

PRENATAL VITAMINS #100TABS NDC 76413-315-01

Batch:
123456
Lot:
123456
Exp:
01/01/01

MAJOR

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

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

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CALCIUM Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NIACIN 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
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-315-01Prenatal100 in 1 BOTTLE, PLASTICTABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-315PRENATAL (VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACIN, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, AND ZINC OXIDE) TABLET [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]11 package rows20170918_e858f2b0-68d6-4b87-ac32-a1cb74282e4d.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76413-31576413-315-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
Vitamin A81G40H8B0TACTIB
Ascorbic AcidPQ6CK8PD0RACTIB
Cholecalciferol1C6V77QF41ACTIB
.Alpha.-TocopherolH4N855PNZ1ACTIB
ThiamineX66NSO3N35ACTIB
RiboflavinTLM2976OFRACTIB
Niacin2679MF687AACTIB
PyridoxineKV2JZ1BI6ZACTIB
Folic acid935E97BOY8ACTIB
CyanocobalaminP6YC3EG204ACTIB
CalciumSY7Q814VUPACTIB
Ferrous fumarateR5L488RY0QACTIM
Zinc oxideSOI2LOH54ZACTIB
Microcrystalline celluloseOP1R32D61UIACT
stearic acid4ELV7Z65APIACT
Hypromellose, Unspecified3NXW29V3WOIACT
croscarmellose sodiumM28OL1HH48IACT
Gelatin, Unspecified2G86QN327LIACT
acacia5C5403N26OIACT
maltodextrin7CVR7L4A2DIACT
titanium dioxide15FIX9V2JPIACT
talc7SEV7J4R1UIACT
triacetinXHX3C3X673IACT
magnesium stearate70097M6I30IACT
Anhydrous Dibasic Calcium PhosphateL11K75P92JIACT
mineral oilT5L8T28FGPIACT
sucroseC151H8M554IACT
Silicon DioxideETJ7Z6XBU4IACT
sodium ascorbateS033EH8359IACT
FD&C Red NO. 40WZB9127XOAIACT
FD&C Yellow NO. 6H77VEI93A8IACT
Aluminum OxideLMI26O6933IACT
TocopherolR0ZB2556P8IACT
Sodium BenzoateOJ245FE5EUIACT
Sorbic acidX045WJ989BIACT
Tricalcium PhosphateK4C08XP666IACT
Butylated Hydroxytoluene1P9D0Z171KIACT
Ascorbyl PalmitateQN83US2B0NIACT

Source Document#

Source XML · Source PDF

Reported adverse events (FAERS/openFDA)#

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