PRENATAL VITAMINS PLUS LOW IRON- prenatal with ferrous fumarate and folic acid tablet

Prenatal Vitamins Plus Low Iron by

Drug Labeling and Warnings

Prenatal Vitamins Plus Low Iron by is a Prescription medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Supplement Facts
Serving Size: 1 Tablet	Amount per Serving	% Daily Value*
* Daily Value is for Pregnant and Lactating Women
Vitamin A	1200 mcg	92%
(Acetate and Beta Carotene)	RAE
Vitamin C (Ascorbic Acid)	120 mg	100%
Vitamin D-3 (Cholecalciferol)	10 mcg	67%
Vitamin E (dl-α Tocopheryl Acetate)	10 mg	53%
Vitamin B-1 (Thiamine Mononitrate)	1.84 mg	131%
Vitamin B-2 (Riboflavin)	3 mg	188%
Niacin (Niacinamide)	20 mg	111%
Vitamin B-6 (Pyridoxine HCl)	10 mg	500%
Folic Acid	1667 mcg	278%
	DFE (1 mg)
Vitamin B-12 (Cyanocobalamin)	12 mcg	429%
Calcium (Calcium Carbonate)	200 mg	15%
Iron (Ferrous Fumarate)	27 mg	100%
Zinc (Zinc Oxide)	25 mg	192%
Copper(Cupric Oxide)	2 mg	154%

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.

BOXED WARNING

(What is this?)

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.

SPL UNCLASSIFIED SECTION

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

Rev 02.1120
Lot/Exp Date

HOW SUPPLIED

Product: 50090-0616

NDC: 50090-0616-0 100 TABLET in a BOTTLE, PLASTIC

Prenatal with Ferrous Fum and Folic Acid

INGREDIENTS AND APPEARANCE

PRENATAL VITAMINS PLUS LOW IRON 
prenatal with ferrous fumarate and folic acid tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 50090-0616(NDC:39328-106)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	924 ug
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J)	.BETA.-CAROTENE	276 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	10 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)	THIAMINE	1.84 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1667 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	200 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	27 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	2 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO)
Magnesium Stearate (UNII: 70097M6I30)
Maltodextrin (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PEG-400 (UNII: B697894SGQ)
Stearic Acid (UNII: 4ELV7Z65AP)
CI 77891 (UNII: 15FIX9V2JP)
FD&C Blue NO. 2 (UNII: L06K8R7DQK)
CURRY RED (UNII: WZB9127XOA)
YELLOW 6 (UNII: H77VEI93A8)

Product Characteristics
Color	BROWN (Beige)	Score	no score
Shape	OVAL (OVAL)	Size	9mm
Flavor		Imprint Code	P;5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-0616-0	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/28/2014
2	NDC: 50090-0616-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014	04/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		04/01/2013

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-0616) , REPACK(50090-0616)