FDA Label for Neonatal Plus Vitamin

View Indications, Usage & Precautions

Neonatal Plus Vitamin Product Label

The following document was submitted to the FDA by the labeler of this product Neomed Pharmaceutical. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Boxed Warning



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.


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: [email protected]


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