PRENATVITE- prenatvite tablet 
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS

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PRENATVITE TABLETS Rx
Prenatal Vitamin With Other Vitamins & Minerals For Nutritional Supplementation

DESCRIPTION

SUPPLEMENT FACTS:

Serving Size: One Tablet

PRENATVITE RX is an orally administered prenatal dietary Supplement and should be administered under the supervision of a licensed medical practitioner.

Each PRENATVITE 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)

4.6 MG

VITAMIN B1 (AS THIAMINE MONONITRATE)

1.5 MG
VITAMIN B2 (AS RIBOFLAVIN)

1.7 MG

VITAMIN B3 (AS NIACINAMIDE)

18 MG

VITAMIN B6 (AS PYRIDOXINE HCL)

2.6 MG

FOLIC ACID

800 MCG

VITAMIN B12 (AS CYANOCOBALAMIN)

4 MCG

CALCIUM (AS CALCIUM CARBONATE & SULFATE)

263 MG

IRON (AS FERROUS FUMARATE)

27 MG

ZINC (AS ZINC OXIDE)

25 MG

INOSITOL

5 MG

CITRUS BIOFLAVONOIDS COMPLEX 50%

2 MG

BORON (AS BORON CITRATE)

0.2 MG

Other Ingredients:

MICRO CRYSTALLINE CELLULOSE, DI CALCIUM PHOSPHATE, STEARIC ACID, CROSCARMELLOSE SODIUM, SILICON DIOXIDE, MAGNESIUM STEARATE, HPMC E15, HPMC E5/E6, PEG - 8000, TALC, FD&C RED # 40 (LAKE), FD&C YELLOW # 6 (LAKE), TRIACETIN.

INDICATIONS
PRENATVITE 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.

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 RX tablet each day at any time of day at about the same time each day. PRENATVITE RX 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 RX 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 73317-1050-9


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 
prenatvite tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:73317-1050
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 ACID100 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE4.6 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE18 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE2.6 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID800 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN4 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) CALCIUM263 mg
BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON0.2 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 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)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TRIACETIN (UNII: XHX3C3X673)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:73317-1050-990 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT02/03/202008/23/2024
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)5 mm
Labeler - SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS (081225162)
Establishment
NameAddressID/FEIBusiness Operations
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS081225162manufacture(73317-1050)

Revised: 9/2024
 
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS