PRENATAL- 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

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Prenatal Tablets

Supplement Facts
Serving Size: 1 Tablet
Amount Per Serving% Daily Value*
*
% Daily Value for Pregnant and Lactating Women
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%

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

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

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

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

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

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

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
PRENATAL 
vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol, thiamine, riboflavin, niacin, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, and zinc oxide tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76413-315
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A4000 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid100 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]
.Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol11 [iU]
Thiamine (UNII: X66NSO3N35) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.5 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.7 mg
Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin18 mg
Pyridoxine (UNII: KV2JZ1BI6Z) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine2.6 mg
Folic acid (UNII: 935E97BOY8) (Folic acid - UNII:935E97BOY8) Folic acid0.8 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin4 ug
Calcium (UNII: SY7Q814VUP) (Calcium - UNII:SY7Q814VUP) Calcium263 mg
Ferrous fumarate (UNII: R5L488RY0Q) (Ferrous cation - UNII:GW89581OWR) Ferrous cation27 mg
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide25 mg
Inactive Ingredients
Ingredient NameStrength
Microcrystalline cellulose (UNII: OP1R32D61U)  
stearic acid (UNII: 4ELV7Z65AP)  
Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
croscarmellose sodium (UNII: M28OL1HH48)  
Gelatin, Unspecified (UNII: 2G86QN327L)  
acacia (UNII: 5C5403N26O)  
maltodextrin (UNII: 7CVR7L4A2D)  
titanium dioxide (UNII: 15FIX9V2JP)  
talc (UNII: 7SEV7J4R1U)  
triacetin (UNII: XHX3C3X673)  
magnesium stearate (UNII: 70097M6I30)  
Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J)  
mineral oil (UNII: T5L8T28FGP)  
sucrose (UNII: C151H8M554)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
sodium ascorbate (UNII: S033EH8359)  
FD&C Red NO. 40 (UNII: WZB9127XOA)  
FD&C Yellow NO. 6 (UNII: H77VEI93A8)  
Aluminum Oxide (UNII: LMI26O6933)  
Tocopherol (UNII: R0ZB2556P8)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Sorbic acid (UNII: X045WJ989B)  
Tricalcium Phosphate (UNII: K4C08XP666)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Ascorbyl Palmitate (UNII: QN83US2B0N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:76413-315-01100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT03/01/2016
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)1 mm
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIBusiness Operations
Central Texas Community Health Centers079674019REPACK, RELABEL
Establishment
NameAddressID/FEIBusiness Operations
Major Pharmaceuticals383359612MANUFACTURE

Revised: 9/2017
Document Id: d06bddec-3077-4c94-8916-41d7b8cf6aff
Set id: e858f2b0-68d6-4b87-ac32-a1cb74282e4d
Version: 1
Effective Time: 20170915
 
Central Texas Community Health Centers