PRENATAL VITAMINS PLUS- vitamin a, vitamin c, vitamin d-3, vitamin e, vitamin b-1, vitamin b-2, niacin, vitamin b-6, calcium, iron, zinc, copper tablet

Prenatal Vitamins Plus by

Drug Labeling and Warnings

Prenatal Vitamins Plus by is a Prescription medication manufactured, distributed, or labeled by Nnodum Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRENATAL VITAMINS PLUS LOW IRON

Supplemental Facts 

Each tablet Contains:	Amount per Tablet	% Daily Value
Vitamin A (Acetate and Beta Carotene)	4000 I.U.	80%
Vitamin C (Ascorbic acid)	120 mg	200%
Vitamin D-3 (Cholecalciferol)	400 I.U.	100%
Vitamin E (dl-Alpha Tocopheryl Acetate)	22 mg	73%
Vitamin B-1 (Thiamine Mononitrate)	1.84 mg	123%
Vitamin B-2 (Riboflavin)	3 mg	176%
Niacin (Niacinaminde)	20 mg	100%
Vitamin B-6 (Pyridoxine HCL)	10 mg	500%
Folic Acid	1 mg	200%
Vitamin B-12 (Cyanocobalamin)	12 mcg	200%
Calcium (from Calcium Carbonate)	200 mg	20%
Iron (Ferrous Fumarate	27 mg	150%
Zinc (Zinc Oxide)	25 mg	167%
Copper (Cupric Oxide)	2 mg	100%

Other Ingredients:

Corn Starch, Dicalcium Phosphate, DL Alpha Tocopherol, FD&C: Blue #2 Lake, FD&C: Red #40 Lake, FD&C: Yellow #6 Lake, Gum Arabic, Hydroxypropyl Methylcellulose, Maltodextrin, Microcrystalline Cellulose, Modified food starch, Polyethylene Glycol (PEG), Polyvinyl Alcohol, Pregelatinized Starch, Silicon Dioxide, Sucrose, Talc, Titanium Dioxide.

Directions:

Before, during and after pregnancy, one tablet daily or as directed by physician.

Caution:

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

Warning:

Accidental overdose of iron-containing products is a leading cause of fetal poisoning in children under six.

KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

In case of acciential overdose, call a physician or Poison Control Center immediately.

Indications:

To promote vitamin and mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non lactating mother. It is also useful for improving nutritional status prior to conception.

Contraindications:

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Storage:

Store at room temperature, USP. Dispense in a well closed light resistant container.

Safety Information:

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Prenatal Vitamins PlusLow iron tablets product label

Rx Only NDC: 63044-150-05

Prenatal Vitamins Plus
Low iron tablets

Vitamins and Mineral
Supplement for pregnant
& lactating women

ZIKS Nnodum Pharmaceuticals

500 Tablets

Manufactured for: Nnodum Pharmaceuticals
Cincinnati, OH 45240 (513) 861-2329
MADE IN THE USA

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INGREDIENTS AND APPEARANCE

PRENATAL VITAMINS PLUS 
vitamin a, vitamin c, vitamin d-3, vitamin e, vitamin b-1, vitamin b-2, niacin, vitamin b-6, calcium, iron, zinc, copper tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 63044-150
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	4000 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	22 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE ION	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	10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
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
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	2 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ACACIA (UNII: 5C5403N26O)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (peach)	Score	no score
Shape	OVAL	Size	7mm
Flavor		Imprint Code	N150
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63044-150-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/25/2016
2	NDC: 63044-150-05	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/25/2016

Labeler - Nnodum Pharmaceuticals (960457273)

Registrant - Nnodum Pharmaceuticals (960457273)

Establishment
Name	Address	ID/FEI	Business Operations
Nnodum Pharmaceuticals		960457273	manufacture(63044-150)