Prenate Essential

Generic Name: prenatal/postnatal multivitamin/mineral/essential fatty acids
Dosage Form: capsule, gelatin 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 Only Dietary Supplement

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
(Pregnant &
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 acetate) 10 IU 33% 33%
Vitamin B6 (as pyridoxine HCl) 26 mg 1300% 1040%
Folate (as ((6S)-N5-methyltetrahydrofolic acid calcium salt (molar equivalent to 600 mcg of folic acid) and 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 formate) Formical® 155 mg 16% 12%
Iron (as ferrous asparto glycinate) Sumalate® 18 mg 100% 100%
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: Bovine gelatin, glycerin, soy lecithin, white beeswax, purified water, soybean oil, 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.

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). 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 1.0 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: Bottles of 30 softgels (75854-313-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

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

THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Formical® is a registered trademark of Nephro-Tech 1, LLC, covered by one or more claims of U.S. Patent No. 6,528,542.

Sumalate® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 5,516,925, 6,716,814, 8,007,846, and 8,425,956.

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

MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30022
1-888-61-AVION

Rev. 0614

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-313-30

Prenate Essential®
Rx prenatal vitamin & DHA
Essential®

• Key vitamins, minerals, and DHA support nutrition

GLUTEN FREE
Rx Only
Dietary Supplement

30 Softgels

AVION
PHARMACEUTICALS

Prenate Essential 
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-313
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 ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 10 [iU]
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 26 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 400 ug
5-METHYLTETRAHYDROFOLIC ACID (5-METHYLTETRAHYDROFOLIC ACID) 5-METHYLTETRAHYDROFOLIC ACID 600 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 13 ug
BIOTIN (BIOTIN) BIOTIN 280 ug
CALCIUM FORMATE (CALCIUM CATION) CALCIUM CATION 155 mg
FERROUS ASPARTO GLYCINATE (FERROUS CATION) FERROUS CATION 18 mg
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 150 ug
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 50 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 300 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 40 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
LECITHIN, SOYBEAN  
WHITE WAX  
WATER  
SOYBEAN OIL  
TITANIUM DIOXIDE  
FD&C YELLOW NO. 5  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 6  
Product Characteristics
Color GREEN, YELLOW (opaque) Score no score
Shape OVAL Size 24mm
Flavor Imprint Code Prenate
Contains         
Packaging
# Item Code Package Description
1 NDC:75854-313-30 30 CAPSULE, GELATIN COATED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/18/2014
Labeler - Avion Pharmaceuticals, LLC (965450542)
Revised: 07/2014
 
Avion Pharmaceuticals, LLC



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