Label: PRENATVITE PLUS tablet
- NHRIC Code(s): 73317-1150-9
- Packager: SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated February 5, 2020
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DESCRIPTION
SUPPLEMENT FACTS:
Serving Size: One Tablet
PRENATVITE PLUS is an orally administered prenatal/postnatal prescription folic acid-containing dietary Supplement and should be administered under the supervision of a licensed medical practitioner.
Each PRENATVITE PLUS tablet contains:
VITAMIN A (AS ACETATE, BETA CAROTENE)
1200 MCG
VITAMIN C (ASCORBIC ACID)
120 MG VITAMIN D3 (AS CHOLECALCIFEROL)
10 MCG
VITAMIN E (AS DL-ALPHA TOCOPHEROL ACETATE)
9.2 MG
VITAMIN B1 (AS THIAMINE MONONITRATE)
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
CALCIUM (AS CALCIUM CARBONATE)
27 MG
IRON (AS FERROUS FUMARATE)
27 MG
ZINC (AS ZINC OXIDE)
25 MG
COPPER (AS CUPRIC OXIDE)
2 MG
INOSITOL
5 MG
CITRUS BIOFLAVONOIDS COMPLEX 50%
2 MG
BORON (AS BORON CITRATE)
0.2 MG
Other Ingredients:
microcrystalline cellulose, stearic acid, magnesium stearate, croscarmellose sodium, silicon dioxide, PEG-8000, talc, HPMC E15, HPMC E5/E6, FD&C RED #40 (LAKE), FD&C BLUE # 2 (LAKE FD&C YELLOW # 6 (LAKE).
INDICATIONS
PRENATVITE PLUS 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. -
WARNINGS
WARNINGS
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.
CAUTION: High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as pernicious anemia), a condition that can cause nerve damage.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 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
DOSAGE AND ADMINISTRATIONOne tablet daily or Take exactly as prescribed by your doctor.
Take PRENATVITE PLUS tablet each day at any time of day at about the same time each day.
PRENATVITE PLUS can be taken with or without food.
STORAGE
Store at 20-25°C (68-77°F) [See USP controlled room temperature].
Do not keep medicine that is out of date or that you no longer need.
Keep PRENATVITE PLUS Tablets and all medicines out of the reach of children.
NOTICE
Contact with moisture can discolor or erode the tablet. -
HEALTH CLAIM
HOW SUPPLIED
Bottles of 90 tablets each - NDC 73317-1150-9
To report a serious adverse event or obtain product information, call 631-524-5758
Call your licensed medical practitioner about side effect.You may report side effects by calling AUM 1-631-524-5758.
Manufactured and Distributed by:
AUM Pharmaceuticals
Hauppauge, NY 11788.Made in USA
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INGREDIENTS AND APPEARANCE
PRENATVITE PLUS
prenatvite plus tabletProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:73317-1150 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 120 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 CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 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) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) HYPROMELLOSES (UNII: 3NXW29V3WO) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:73317-1150-9 90 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 02/03/2020 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 size (solid drugs) 5 mm shape Labeler - SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS (081225162) Establishment Name Address ID/FEI Business Operations SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS 081225162 repack(73317-1150)