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Prenate Essential

Generic name: prenatal/postnatal multivitamin/mineral/essential fatty acids
Dosage form: capsule, gelatin coated
Drug class: Iron products, Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Jan 1, 2021.

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.

Rx prenatal vitamin & DHA

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.

Prenate Essential ® contains fish oil and soy.

OTHER INGREDIENTS: Capsule gelatin (gelatin, sorbitol, glycerin, purified water, turmeric, and sodium copper chlorophyllin), soy lecithin, yellow beeswax and soybean oil.

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 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 B 12 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.]

MANUFACTURED FOR: Avion Pharmaceuticals, LLC

Atlanta, GA 30005

1-888-61-AVION

Rev. 0519-01

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-313-30

Prenate Essential ®

Rx prenatal vitamin & DHA

• Key vitamins, minerals, and DHA support nutrition

GLUTEN FREE

Rx Only

Dietary Supplement

30 Softgels

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
ICOSAPENT (ICOSAPENT) ICOSAPENT 40 mg
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
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 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 (040348516)
Establishment
Name Address ID/FEI Operations
Avion Pharmaceuticals, LLC 040348516 manufacture(75854-313)
Avion Pharmaceuticals, LLC