PRENATAL PLUS VITAMINS- prenatal with ferrous fumarate and folic acid tablet 
Patrin Pharma, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Supplement Facts
Serving Size: 1 TabletAmount per Serving% Daily Value*
*
Daily Value is for Pregnant and Lactating Women
Vitamin A1200 mcg92%
(Acetate and Beta Carotene)RAE
Vitamin C (Ascorbic Acid)120 mg100%
Vitamin D-3 (Cholecalciferol)10 mcg67%
Vitamin E (dl-α Tocopheryl Acetate)10 mg53%
Vitamin B-1 (Thiamine Mononitrate)1.84 mg131%
Vitamin B-2 (Riboflavin)3 mg188%
Niacin (Niacinamide)20 mg111%
Vitamin B-6 (Pyridoxine HCl)10 mg500%
Folic Acid1667 mcg278%
DFE (1 mg)
Vitamin B-12 (Cyanocobalamin)12 mcg429%
Calcium (Calcium Carbonate)200 mg15%
Iron (Ferrous Fumarate)27 mg100%
Zinc (Zinc Oxide)25 mg192%
Copper(Cupric Oxide)2 mg154%

Other Ingredients: Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Stearic Acid, Titanium Dioxide, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #6 lake

Description

Prenatal Plus Vitamins is a prescription folic acid containing dietary vitamin and mineral supplement for women before, during and after pregnancy.

Directions

Use before, during and after pregnancy under the supervision of a medical professional. One tablet daily or as prescribed.

Caution

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

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 Physician or Poison Control Center immediately.

Storage

Store at room temperature, USP. Protect from light and moisture. Dispense in a tight, light-resistant container. Contact with moisture may discolor or erode tablets.

Manufactured for Patrin Pharma
Skokie, IL 60076
Call (800) 936 3088

Rev 02.1120
Lot/Exp Date

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

Rx
Only

NDC 39328-106-10

Prenatal Plus
Vitamins

27 mg Fe & 1 mg FA

Before, During and After
Pregnancy

100 tablets
Made in the USA

PATRIN
PHARMA

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
PRENATAL PLUS VITAMINS 
prenatal with ferrous fumarate and folic acid tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:39328-106
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Vitamin A Acetate (UNII: 3LE3D9D6OY) (Vitamin A - UNII:81G40H8B0T) Vitamin A924 ug
Beta Carotene (UNII: 01YAE03M7J) (Beta Carotene - UNII:01YAE03M7J) Beta Carotene276 ug
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid120 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol10 ug
.Alpha.-TocopheroL Acetate, DL- (UNII: WR1WPI7EW8) (.Alpha.-Tocopherol, DL- - UNII:7QWA1RIO01) .Alpha.-Tocopherol, DL-10 mg
Thiamine Mononitrate (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.84 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin3 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide20 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride10 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1667 ug
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin12 ug
Calcium Carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) Calcium Carbonate200 mg
Ferrous Fumarate (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide25 mg
Cupric Oxide (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
Inactive Ingredients
Ingredient NameStrength
Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
Magnesium Stearate (UNII: 70097M6I30)  
Maltodextrin (UNII: 7CVR7L4A2D)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
FD&C Blue NO. 2 (UNII: L06K8R7DQK)  
FD&C Red NO. 40 (UNII: WZB9127XOA)  
FD&C Yellow NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorBROWN (Beige) Scoreno score
ShapeOVAL (OVAL) Size9mm
FlavorImprint Code P;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:39328-106-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2013
2NDC:39328-106-50500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/201311/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/01/2013
Labeler - Patrin Pharma, Inc. (806841677)

Revised: 1/2022
Document Id: 3ca7c2e1-8af0-48ae-893a-8f4e06eac6a9
Set id: 59c5c1a4-3f42-441a-b842-903f9bab346f
Version: 3
Effective Time: 20220113
 
Patrin Pharma, Inc.