PRENATE ESSENTIAL – ascorbic acid, cholecalciferol, alpha-tocopherol, pyridoxine, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent capsule, gelatin coated 
Sciele Pharma, Inc.

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Prenate® Essential™
Rx prenatal vitamin & DHA

DESCRIPTION

PRENATE ESSENTIAL™ is a prescription prenatal/postnatal multivitamin/mineral/ essential fatty acid softgel. Each softgel is blue-green in color, opaque, and imprinted with “Prenate” on one side.

Percent Daily Values are based on a 2,000 calorie diet
*
Daily Value (DV) not established
Supplement Facts
Serving Size 1 Softgel
Amount Per Serving: % DV
For Adults
% DV for Pregnant and Lactating Women
Vitamin C 85 mg   142% 142%
Vitamin D3 200 IU 50%   50%  
Vitamin E 10 IU     33%   33%  
Vitamin B6 25 mg     1250%   1000%
Folate 1 mg     250% 125%
  (L-methylfolate as Metafolin 600 mcg)
  (folic acid, USP 400mcg)
Vitamin B12 12 mcg 200% 150%
Biotin   300 mcg 100% 100%
Calcium
  (calcium carbonate)
140 mg 14%   11%  
Iron (ferrous fumarate) 28 mg   156% 156%
Iodine (potassium iodide)   150 mcg 100% 100%
Magnesium
  (magnesium oxide)
45 mg   11%   10%  
Docosahexaenoic Acid (DHA) 300 mg * *
Eicosapentaenoic Acid (EPA) 40mg     * *
  (from 340 mg omega-3 fatty acids from fish oil)

Other Ingredients: fish oil, gelatin, hydrogenated vegetable oil, glycerin, sorbitol, beeswax, soy lecithin, titanium dioxide, vanillin, FD&C blue No. 1, propylene glycol, hypromellose.

INDICATIONS

PRENATE ESSENTIAL is a multivitamin/mineral/essential fatty acid nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. PRENATE ESSENTIAL can also be beneficial in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS

PRENATE ESSENTIAL is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING

Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administsration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

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 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

Before, during, and/or after pregnancy, one softgel daily or as directed by a physician.

HOW SUPPLIED

Unit-dose packs of 30 softgels

 
NDC # 59630-419-30

KEEP THIS AND ALL DRUGS OUT OF THE 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]
For inquiries call 1-800-849-9707 extension 1454.

PNE-BC3-1
Rev. 01/10

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

Prenate Essential® 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, Georgia USA 30328 Manufactured by:
Catalent Pharma Solutions, Swindon, UK.
Made in the United Kingdom

Prenate® Essential™
Rx prenatal vitamin & DHA
With
META FOLIN®

PRINCIPAL DISPLAY PANEL – 30 Softgel Carton

NDC-59630-419-30

30 Softgels

Prenate® Essential™
Rx prenatal vitamin & DHA

With
META FOLIN®

Rx Only

US Patents #5,997,915;#6,254,904;#6,011,040;#6,451,360;#6,673,381;#6,808,725#6,441,168
Metafolin® is a registered trademark of Merck KGaA, Darmstadt Germany
©2010 Shionogi Pharma, Inc. Atlanta, GA
All rights reserved.


PRENATE ESSENTIAL 
ascorbic acid, cholecalciferol, alpha-tocopherol, pyridoxine, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent, and icosapent  capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59630-419
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 85 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 200 [iU]
Alpha-Tocopherol (Alpha-Tocopherol) Alpha-Tocopherol 10 [iU]
Pyridoxine (Pyridoxine) Pyridoxine 25 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 1 mg
Biotin (Biotin) Biotin 300 ug
Calcium carbonate (Calcium) Calcium carbonate 140 mg
Ferrous fumarate (Iron) Ferrous fumarate 28 mg
Potassium iodide (Potassium cation) Potassium iodide 150 ug
Magnesium oxide (Magnesium oxide) Magnesium oxide 45 mg
Doconexent (Doconexent) Doconexent 300 mg
Icosapent (Icosapent) Icosapent 40 mg
Inactive Ingredients
Ingredient Name Strength
gelatin  
glycerin  
sorbitol  
wax, yellow  
lecithin, soybean  
titanium dioxide  
vanillin  
FD&C blue No. 1  
Propylene glycol  
hypromellose  
Product Characteristics
Color BLUE (blue-green) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code Prenate
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 59630-419-30 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK
1 10 CAPSULE In 1 BLISTER PACK This package is contained within the CARTON (59630-419-30)
2 59630-419-10 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK
2 10 CAPSULE In 1 BLISTER PACK This package is contained within the CARTON (59630-419-10)
3 59630-419-05 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK
3 5 CAPSULE In 1 BLISTER PACK This package is contained within the CARTON (59630-419-05)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 03/30/2010

Labeler – Sciele Pharma, Inc. (802728477)
Revised: 02/2010Sciele Pharma, Inc.