Label: NEONATAL PLUS VITAMIN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 70898-115-01 - Packager: NEOMED PHARMACEUTICAL
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated September 18, 2020
If you are a consumer or patient please visit this version.
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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
- CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
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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: info@neomedpharmaceutical.com
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NEONATAL PLUS VITAMIN
neonatal plus vitamin tabletProduct 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 GLYCOL 8000 (UNII: Q662QK8M3B) 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)
