NATAL-V RX MULTI-VITAMIN/MULTI-MINERAL - beta carotene, ascorbic acid, 24-homo-1,25-dihydroxyvitamin d3, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, potassium iodide, magnesium oxide, zinc oxide and cupric oxide tablet 
Rochester Pharmaceuticals

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NDC 49908-204-90

RX ONLY

Natal-V RX Tablets

Multi-vitamin/Multi-mineral

90 Tablets

INDICATIONS:

To provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and nonlactating mother.

Each tablet is pink colored, oval shaped, and embossed with “RP204” on one side.

EACH TABLET CONTAINS

Serving Size: 1 Tablet

Amount Per Serving

% Daily Value*

Vitamin A (Beta Carotene)

4000 IU

50%

Vitamin C (Ascorbic Acid)

120 mg

200%

Vitamin D-3 (Cholecalciferol)

400 IU

100%

Vitamin E (di-Alpha Thocopheryl Acetate)

30 IU

100%

Vitamin B-1 (Thiamine Mononitrate)

3 mg

176%

Vitamin B-2 (Riboflavin)

3 mg

150%

Niacinamide (Vitamin B-3)

20 mg

100%

Vitamin B-6 (Pyridoxine HCL)

3 mg

120%

Folic Acid

1 mg

125%

Vitamin B-12 (Cyanocobalamin)

8 mcg

100%

Biotin

30 mcg

10%

Pantothenic Acid (Calcium Panotothenate)

7 mg

70%

Calcium (Calcium Carbonate)

200 mg

15%

Iron (Carbonyl Iron)

29 mg

161%

Iodine (Potassium Iodide)

150 mcg

100%

Magnesium (Magnesium Oxide)

100 mg

22%

Zinc (Zinc Oxide)

15 mg

100%

Copper (Cupric Oxide)

3 mg

150%

Daily Value for Pregnant and Lactating Women.

OTHER INGREDIENTS:

Microcrystilline Cellulose, Starcap 1500, Pink Coating (Polyethylene Glycol, Polyvinyl alcohol, Titanium Dioxide, Talc, FD and C Blue #1, FD and C Red #40 and FD and C Yellow #6), Collodial Silicon Dioxide, Magnesium Stearate.

WARNINGS

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center Immediately.

CONTRAINDICATIONS:

This product is contraindicated in patients with a known hypersensitivity to any of the components of this product.  Hemochromatosis and hemosiderosis as contraindications to iron therapy.

PRECAUTIONS

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.  Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.

CAUTION:

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megalobastic anemias where Vitamin B-12 is deficient.

ADVERSE REACTIONS:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DIRECTIONS:

One tablet daily or as directed by a physician.

Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). Brief exposure to temperatures up to 40ºC (104ºF) may be tolerated provided the mean kinetic temperature does not exceed 25ºC (77ºF); however, such exposure should be minimized.

KEEP OUT OF REACH OF CHILDREN

To report a serious adverse event or to obtain product information, contact 1-866-458-1772

Manufactured for:

Rochester Pharmaceuticals

Rochester, NY 14624

www.RochesterPharm.com

834940

12/12

LABEL:

image description

NATAL-V RX MULTI-VITAMIN/MULTI-MINERAL 
(beta carotene, ascorbic acid, cholecalciferol, di-alpha thocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, biotin, calcium panotothenate, calcium carbonate, carbonyl iron, potassium iodide, magnesium oxide, zinc oxide, cupric oxide), tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:49908-204
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETA CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) BETA CAROTENE4000 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
24-HOMO-1,25-DIHYDROXYVITAMIN D3 (UNII: F35KTH803S) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE3 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN8 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN30 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID7 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON29 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE150 ug
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION3 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize21mm
FlavorImprint Code RP204
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:49908-204-9090 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
dietary supplement05/13/201303/01/2015
Labeler - Rochester Pharmaceuticals (069874500)

Revised: 4/2015
 
Rochester Pharmaceuticals