NEONATAL PLUS VITAMIN: Package Insert and Label Information

NEONATAL PLUS VITAMIN- vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, ferrous fumarate, inositol, citrus bioflavonoids, calcium, boron, zinc oxide and copper tablet
NEOMED PHARMACEUTICAL

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.

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.

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 )

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.

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

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

100 Count
(click image for full-size original)

NEONATAL PLUS VITAMIN
neonatal plus vitamin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70898-115
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A (VITAMIN A) VITAMIN A 1200 ug
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 20 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 10 ug
.ALPHA.-TOCOPHEROL ACETATE (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL ACETATE 9.2 mg
THIAMINE (THIAMINE ION) THIAMINE 1.84 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 10 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1000 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 27 mg
INOSITOL (INOSITOL) INOSITOL 5 mg
CITRUS BIOFLAVONOIDS (HESPERIDIN) CITRUS BIOFLAVONOIDS 2 mg
CALCIUM (CALCIUM) CALCIUM 200 mg
BORON (BORON) BORON 0.2 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 25 mg
COPPER (COPPER) COPPER 2 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MICROCRYSTALLINE CELLULOSE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
STEARIC ACID
SILICON DIOXIDE
TITANIUM DIOXIDE
MAGNESIUM STEARATE
TALC
POLYETHYLENE GLYCOL 8000
HYPROMELLOSES
TRIACETIN
SUCROSE
FD&C RED NO. 40
FD&C YELLOW NO. 6
Product Characteristics
Color brown (BEIGE/PEACH) Score no score
Shape CAPSULE (Caplet) Size 5mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70898-115-01 1 BOTTLE in 1 PACKAGE contains a BOTTLE
1 100 TABLET in 1 BOTTLE This package is contained within the PACKAGE (70898-115-01)
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)

Revised: 09/2020 NEOMED PHARMACEUTICAL

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