Label: NEONATAL VITAMIN tablet
- NHRIC Code(s): 70898-105-01
- Packager: NEOMED PHARMACEUTICAL
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated September 18, 2020
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STATEMENT OF IDENTITY
SUPPLEMENT FACTS:
Serving Size: One Tablet
Each Tablet contains:
Vitamin A (as acetate, beta carotene)
1200 mcg
Vitamin D3 (as cholecalciferol)
10 mcg
Vitamin E (as dl-alpha topcopheryl acetate )
4.6 mg
Vitamin C (Ascorbic acid )
100 mg
Vitamin B1 (as thiamine HCl)
1.5 mg
Vitamin B2 (as riboflavin)
1.7 mg
Vitamin B3 (as niacinamide)
1.8 mg
Vitamin B6 (as pyridoxine HCl)
2.6 mg
Folic acid
800 mcg
Vitamin B12 (as cyanocobalamin)
4 mcg
Iron (as ferrous fumarate )
27 mg
Citrus bioflavonoids complex 50% bio flavonoids
2 mg
Calcium (as carbonate sulfate )
263 mg
Zinc (as zinc oxide )
25 mg
Boron (as boron citrate )
0.2 mg
Inositol
5 mg
Other Ingredients: Dibasic calcium phosphate, 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 )
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WARNINGS
WARNINGS
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
DOSAGE & ADMINISTRATION
As with any supplement, if you are pregnant, nursing, or taking medication, consult your doctor before use.
The safe upper limit for daily intake of folic acid is 1000 mcg (1 mg).
Do not take Prenatal with other multivitamin formulas unless recommended by your doctor.
IMPORTANT INFORMATION
Long-term intake of high levels of vitamin A (excluding that sourced from beta-carotene) may increase the risk of osteoporosis in adults. Do not take this product if taking other vitamin A supplements.
Information for Patients
Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breastfeeding.
Pediatric Use
Not recommended for pediatric use.
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HEALTH CLAIM
HOW SUPPLIED
NEONATAL VITAMIN ; available in bottles of 100 Tablets. 70898-105-01
SAFE HANDLING WARNING
Store at room temperature.
Avoid excessive heat above 40°C (104°F.)QUESTIONS? COMMENTS?
Manufactured for:
NEOMED Pharmaceutical,
Hauppauge, NY-11788.REV.:08/20
Distributed by:
AUM Pharmaceuticals,
320 Oser Ave.Hauppauge, NY-11788.
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.
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INGREDIENTS AND APPEARANCE
NEONATAL VITAMIN
neonatal vitamin tabletProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:70898-105 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 100 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 10 ug .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE 4.6 mg THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.5 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.7 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 1.8 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 2.6 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 800 ug CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 4 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 263 mg BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON 0.2 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 25 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:70898-105-01 1 in 1 PACKAGE 1 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 07/31/2018 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 5 mm Labeler - NEOMED PHARMACEUTICAL (048388130)