PRENATVITE PLUS- prenatvite plus tablet 
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS

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PRENATVITE PLUS TABLETS Rx
Prenatal Vitamin Tablet with Prescription Folic Acid

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

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 ADMINISTRATION

One 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.

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

image description

PRENATVITE PLUS 
prenatvite plus tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:73317-1150
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1200 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE9.2 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.84 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1000 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
INOSITOL (UNII: 4L6452S749) (INOSITOL - UNII:4L6452S749) INOSITOL5 mg
CITRUS BIOFLAVONOIDS (UNII: BD70459I50) (HESPERIDIN - UNII:E750O06Y6O) CITRUS BIOFLAVONOIDS2 mg
CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM200 mg
BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON0.2 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:73317-1150-990 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT02/03/2020
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
size (solid drugs)5 mm
shape
Labeler - SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS (081225162)
Establishment
NameAddressID/FEIBusiness Operations
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS081225162repack(73317-1150)

Revised: 2/2020
Document Id: 5ec27a73-765c-4b69-ba26-e216f882427c
Set id: cfbecd41-379b-4d44-b7d5-066c11335a57
Version: 1
Effective Time: 20200205
 
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS