NEONATAL PLUS VITAMIN tablet

NEONATAL PLUS VITAMIN by

Drug Labeling and Warnings

NEONATAL PLUS VITAMIN by is a Prescription medication manufactured, distributed, or labeled by NEOMED PHARMACEUTICAL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOXED WARNING

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WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

STATEMENT OF IDENTITY

Each prenatal tablet contains:

Each Tablet contains:
Vitamin A (as acetate, beta carotene)		1200 mcg
Vitamin D3 (as cholecalciferol)		10 mcg
Vitamin E (as dl-alpha topcopheryl acetate )		9.2 mg
Vitamin C (Ascorbic acid )		20 mg
Vitamin B1 (as thiamine HCl)		1.84 mg
Vitamin B2 (as riboflavin)		3 mg
Vitamin B3 (as niacinamide)		20 mg
Vitamin B6 (as pyridoxine HCl)		10 mg
Folic acid		1000 mcg
Vitamin B12 (as cyanocobalamin)		12 mcg
Iron  (as ferrous fumarate )		27 mg
Citrus bioflavonoids complex 50% bio flavonoids		2 mg
Calcium (as carbonate sulfate )		200 mg
Zinc (as zinc oxide )		25 mg
Copper (as cupric oxide)		2 mg
Boron (as boron citrate )		0.2 mg
Inositol		5 mg

Other Ingredients: , microcrystalline  croscarmellose sodium, stearic acid, silicon dioxide, titanium dioxide (as color), polyethylene glycol, sucrose, magnesium stearate, talc,triacetin, HPMC E15,HPMC E5/E6,FD&C RED #40 (LAKES),FD&C YELLOW # 6 (LAKE )

INDICATIONS & USAGE

NEONATAL PLUS TABLET  Rx is a multi-vitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

CONTRAINDICATIONS

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

WARNINGS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

PRECAUTIONS

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

To report a serious adverse event or obtain product information, call 631-524-5758

DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

HOW SUPPLIED

Bottles of 100 tablets each - NDC 70898-115-01

STORAGE

Store at 20-25°C (68-77°F) [See USP controlled room temperature].

To report a serious adverse event or obtain product information, call 631-524-5758

Distributed by:

Neomed Pharmaceutical ,80 Cain Dr, Brentwood,NY 11717

Phone :631-524-5758

Email: info@neomedpharmaceutical.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NEONATAL PLUS VITAMIN 
neonatal plus vitamin tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70898-115
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	1200 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	20 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	10 ug
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	9.2 mg
THIAMINE (UNII: X66NSO3N35) (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	10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1000 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	27 mg
INOSITOL (UNII: 4L6452S749) (INOSITOL - UNII:4L6452S749)	INOSITOL	5 mg
CITRUS BIOFLAVONOIDS (UNII: BD70459I50) (HESPERIDIN - UNII:E750O06Y6O)	CITRUS BIOFLAVONOIDS	2 mg
CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP)	CALCIUM	200 mg
BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q)	BORON	0.2 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 mg
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	2 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TRIACETIN (UNII: XHX3C3X673)
SUCROSE (UNII: C151H8M554)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	brown (BEIGE/PEACH)	Score	no score
Shape	CAPSULE (Caplet)	Size	5mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70898-115-01	1 in 1 PACKAGE	07/31/2018
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/31/2018

Labeler - NEOMED PHARMACEUTICAL (048388130)