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
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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