PRENATE ELITE – vitamin a, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cyanocobalamin, biotin, pantothenic acid, calcium carbonate, ferrous fumarate, iodine, magnesium, zinc and copper tablet, film coated 
Shionogi Pharma, Inc.

———-

PRENATE ELITE® Tablets Rx

DESCRIPTION

PRENATE ELITE® is a white oval oil- and water-soluble multivitamin/multimineral film-coated tablet debossed with “PN” on one side.

 * Percent Daily Values (DV) are based on a 2,000 calorie diet
 Supplement Facts
 Serving Size 1 Tablet
 Amount Per Serving    % DV  % DV for Pregnant and Lactating Women
 Vitamin A
(100% as Beta-Carotene)
 2500 IU  50 %  31 %
 Vitamin C  80 mg  133 %  133 %
 Vitamin D3  400 IU  100 %  100 %
 Vitamin E  10 IU  33 %    33 %
 Thiamin (Vitamin B1)  3 mg  200 %  176 %
 Riboflavin (Vitamin B2)  3.4 mg  200 %  170 %
 Niacinamide  20 mg  100 %  100 %
 Vitamin B6  20 mg  1000 %  800 %
 Folate  1 mg  250 %  125 %
   (L-methylfolate calcium 676 mcg (as Metafolin®) molar equivalent to 600 mcg of Folic Acid)      
   (Folic acid, USP 400 mcg)      
 Vitamin B12  12 mcg  200 %  150 %
 Biotin  300 mcg  100 %  100 %
 Pantothenic acid  6 mg  60 %  60 %
 Calcium (calcium carbonate)  120 mg  12 %  9 %
 Iron (ferrous fumarate)  27 mg  150 %  150 %
 Iodine  150 mcg  100 %  100 %
 Magnesium  30 mg  8 %  7 %
 Zinc  15 mg  100 %  100 %
 Copper  2 mg  100 %  100 %

Other Ingredients: ascorbyl palmitate, calcium sulfate, croscarmellose sodium, dicalcium phosphate, gelatin, hydrogenated soybean oil, hydrogenated vegetable oil, hypromellose, magnesium stearate, maltodextrin, medium chain triglycerides, microcrystalline cellulose, mono and diglycerides, partially hydrogenated soybean oil, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, sodium aluminum silicate, sodium ascorbate, starch, stearic acid, sucrose, talc, titanium dioxide, and water.

Metafolin® (L-methylfolate calcium) is a substantially diastereoisomerically pure source of L-methylfolate containing not more than 1% D-methylfolate.

INDICATIONS

PRENATE ELITE® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE ELITE® can also be beneficial in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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.

PRECAUTIONS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1.0 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 as directed by a physician.

HOW SUPPLIED

Child-resistant bottles of 90 tablets – NDC 59630-416-90

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

U.S. Patents #5,997,915; #6,011,040; #6,254,904; #6,441,168; #6,451,360; #6,673,381; #6,808,725

Prenate Elite® is a registered trademark of Shionogi Pharma, Inc. Metafolin® is a registered
trademark of Merck KGaA, Darmstadt, Germany.
©2010 Shionogi Pharma, Inc. Atlanta, GA.
All rights reserved.

Manufactured for:
SHIONOGI PHARMA, INC.
Atlanta, GA 30328

Manufactured by:
Pharmetics, Inc.
Laval, Quebec H7L 3H7

Made in Canada

To report a serious adverse event or obtain product information,
contact 1-800-849-9707 ext. 1454

PNI-PI-3
Rev. 02/10

PRINCIPAL DISPLAY PANEL – 90 Tablets Bottle Label

NDC 59630-416-90

Prenate Elite®
PRENATAL VITAMINS—FILM-COATED TABLETS
With
METAFOLIN®

90 Tablets
Rx Only

Manufactured for:
SHIONOGI PHARMA, INC.
Atlanta, GA 30328

Manufactured by:

Pharmetics Inc.
Laval, Quebec H7L 3H7
Made in Canada

PNI-TL-2

Rev. 02/10

8633-1


PRENATE ELITE 
vitamin a, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine, riboflavin, niacinamide, pyri  tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59630-416
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A (VITAMIN A) VITAMIN A 2500 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 80 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 10 [iU]
THIAMINE (THIAMINE) THIAMINE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
BIOTIN (BIOTIN) BIOTIN 300 ug
PANTOTHENIC ACID (PANTOTHENIC ACID) PANTOTHENIC ACID 6 mg
CALCIUM CARBONATE (CALCIUM) CALCIUM CARBONATE 120 mg
FERROUS FUMARATE (IRON) FERROUS FUMARATE 27 mg
IODINE (IODINE) IODINE 150 ug
MAGNESIUM (MAGNESIUM) MAGNESIUM 30 mg
ZINC (ZINC) ZINC 15 mg
COPPER (COPPER) COPPER 2 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBYL PALMITATE  
CALCIUM SULFATE  
CROSCARMELLOSE SODIUM  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
GELATIN  
HYDROGENATED SOYBEAN OIL  
HYPROMELLOSES  
MAGNESIUM STEARATE  
MALTODEXTRIN  
MEDIUM-CHAIN TRIGLYCERIDES  
CELLULOSE, MICROCRYSTALLINE  
COCO-GLYCERIDES  
POLYVINYL ALCOHOL  
POLYETHYLENE GLYCOL  
POVIDONE  
SILICON DIOXIDE  
SODIUM ALUMINIUM SILICATE  
SODIUM ASCORBATE  
STARCH, CORN  
STEARIC ACID  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
WATER  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 18mm
Flavor Imprint Code PN
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 59630-416-90 1 BOTTLE In 1 CARTON contains a BOTTLE
1 90 TABLET In 1 BOTTLE This package is contained within the CARTON (59630-416-90)
2 59630-416-05 1 BOTTLE In 1 CARTON contains a BOTTLE
2 5 TABLET In 1 BOTTLE This package is contained within the CARTON (59630-416-05)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/01/2008

Labeler – Shionogi Pharma, Inc. (802728477)
Revised: 12/2010Shionogi Pharma, Inc.