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

Prenatal Plus Vitamins by

Drug Labeling and Warnings

Prenatal Plus Vitamins by is a Prescription medication manufactured, distributed, or labeled by REMEDYREPACK INC.. 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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PRINCIPAL DISPLAY PANEL

DRUG: Prenatal Plus Vitamins

GENERIC: prenatal with ferrous fumarate and folic acid

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-4258-0

COLOR: brown

SHAPE: OVAL

SCORE: No score

SIZE: 9 mm

IMPRINT: P;5

PACKAGING: 100 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

• Vitamin A Acetate 924ug in 1
• Beta Carotene 276ug in 1
• Ascorbic Acid 120mg in 1
• Cholecalciferol 10ug in 1
• .Alpha.-TocopheroL Acetate, DL- 10mg in 1
• Thiamine Mononitrate 1.84mg in 1
• Riboflavin 3mg in 1
• Niacinamide 20mg in 1
• Pyridoxine Hydrochloride 10mg in 1
• Folic Acid 1667ug in 1
• Cyanocobalamin 12ug in 1
• Calcium Carbonate 200mg in 1
• Ferrous Fumarate 27mg in 1
• Zinc Oxide 25mg in 1
• Cupric Oxide 2mg in 1

INACTIVE INGREDIENT(S):

• Hypromellose, Unspecified
• Magnesium Stearate
• Maltodextrin
• Microcrystalline Cellulose
• Polyethylene Glycol 400
• Stearic Acid
• Titanium Dioxide
• FD&C Blue NO. 2
• FD&C Red NO. 40
• FD&C Yellow NO. 6

INGREDIENTS AND APPEARANCE

PRENATAL PLUS VITAMINS 
prenatal with ferrous fumarate and folic acid tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70518-4258(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
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
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: 70518-4258-0	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/20/2025

Labeler - REMEDYREPACK INC. (829572556)