Prenate Essential

Generic Name: ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent
Dosage Form: tablet, coated

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Prenate Essential®

Rx prenatal vitamin & DHA

With
Quatrefolic®

Rx Only

DESCRIPTION: Prenate Essential® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is green in color, opaque, and imprinted with 'Prenate' on one side and blank on the other.

*
Daily Value (DV) not established.
Supplement Facts
Serving Size: 1 Softgel
   
Amount per Serving: % Daily Value % Daily Value for
Lactating Women
Vitamin C (as ascorbic acid) 90 mg 150% 150%
Vitamin D3 (as cholecalciferol) 220 IU 55% 55%
Vitamin E (as dl-alpha tocopheryl) 10 IU 33% 33%
Vitamin B6 (as pyridoxine HCl) 26 mg 1300% 1040%
Folate
(as 1.1 mg Quatrefolic® ((6S)-5,methyltetrahydrofolate glucosamine salt* CAS 1181972-37-1) molar equivalent to 600 mcg of Folic Acid) (folic acid, USP 400 mcg)
1 mg 250% 125%
Vitamin B12 (as cyanocobalamin) 13 mcg 217% 163%
Biotin 280 mcg 93% 93%
Calcium (as calcium carbonate) 145 mg 15% 11%
Iron (as ferrous fumarate) 29 mg 161% 161%
Iodine (as potassium iodine) 150 mcg 100% 100%
Magnesium (as magnesium oxide) 50 mg 13% 11%
Docosahexaenoic Acid (DHA) 300 mg * *
Eicosapentaenoic Acid (EPA) 40 mg * *

Prenate Essential® contains fish oil and soy.

OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, soy lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Yellow #5, FD&C Blue #1 and FD&C Yellow #6.

INDICATIONS: Prenate Essential® is a multivitamin/multimineral fatty acid dietary 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 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 Ration (INR). Administration 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.

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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

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.

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. (75854-303-30).

The listed product number is not a National Drug Code, but has instead merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

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

MANUFACTURED FOR: Avion Pharmaceuticals, LLC
Atlanta, GA 30350
1-888-61-AVION

*Quatrefolic® is a registered trademark of Gnosis, SpA.Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1

Prenate Essential® is a registered trademark of Acella Pharmaceuticals, LLC.
Under license from Acella Pharmaceuticals, LLC.
All rights reserved.

Rev. 021412

To learn more about your pregnancy, go to www.PrenatePERL.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-303-30         30 Softgels

Prenate Essential®
Rx prenatal vitamin & DHA
Essential®

with
Quatrefolic®

• Key vitamins, minerals, and DHA support nutrition

Long lasting stability
Improved bioavailability
High water solubility
Established safety

Quatrefolic®            Rx Only

Prenate DHA is a registered trademark of Acella Pharmaceuticals, LLC.
*Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1
Under license from Acella Pharmaceuticals, LLC.
All rights reserved.

Prenate Essential 
- ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-303
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 90 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 220 [iU]
.ALPHA.-TOCOPHEROL, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 10 [iU]
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 26 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 13 ug
BIOTIN (BIOTIN) BIOTIN 280 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 145 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 29 mg
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 150 ug
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 50 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 300 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 40 mg
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX  
CORN OIL  
LECITHIN, SOYBEAN  
GELATIN  
GLYCERIN  
WATER  
TITANIUM DIOXIDE  
FD&C YELLOW NO. 5  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 6  
Product Characteristics
Color GREEN, YELLOW (opaque) Score 2 pieces
Shape OVAL Size 24mm
Flavor Imprint Code Prenate
Contains         
Packaging
# Item Code Package Description
1 NDC:75854-303-30 30 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 30 TABLET, COATED (CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/12/2012
Labeler - Avion Pharmaceuticals, LLC (965450542)
Revised: 05/2013
 
Avion Pharmaceuticals, LLC



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