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Prenate DHA

Generic Name: ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent
Dosage Form: capsule, gelatin coated

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 Only Dietary Supplement

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

Prenate DHA ® contains fish oil and soy.

OTHER INGREDIENTS: Gelatin capsule (FD&C Blue #1, FD&C Red #3, gelatin, glycerin, purified water, sorbitol and titanium dioxide), soybean oil, soy lecithin, and white beeswax.

INDICATIONS: Prenate DHA ® 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 DHA ® can also be beneficial in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS: Prenate DHA ® 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 (75854-312-30).

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.

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

Alpharetta, Georgia 30005

1-888-61-AVION

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 Avion Pharmaceuticals, LLC. Under license from Avion Pharmaceuticals, LLC.

All rights reserved.

Rev. 0519-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-312-30

Prenate DHA ®

Rx prenatal vitamin & DHA

  • Key vitamins, minerals, and DHA support nutrition

GLUTEN FREE

Rx Only

Dietary Supplement

30 Softgels

Prenate DHA
ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-312
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 400 [iU]
.ALPHA.-TOCOPHEROL, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 40 [iU]
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 26 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 25 ug
CALCIUM FORMATE (CALCIUM CATION) CALCIUM CATION 155 mg
FERROUS ASPARTO GLYCINATE (FERROUS CATION) FERROUS CATION 18 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 50 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 300 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
GLYCERIN
LECITHIN, SOYBEAN
SOYBEAN OIL
WHITE WAX
WATER
FD&C BLUE NO. 1
TITANIUM DIOXIDE
FD&C RED NO. 3
Product Characteristics
Color blue (opaque) Score no score
Shape OVAL Size 24mm
Flavor Imprint Code 301
Contains
Packaging
# Item Code Package Description
1 NDC:75854-312-30 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 06/05/2014
Labeler - Avion Pharmaceuticals, LLC (040348516)
Registrant - Avion Pharmaceuticals, LLC (965450542)
Establishment
Name Address ID/FEI Operations
Avion Pharmaceuticals, LLC 040348516 manufacture(75854-312)
Avion Pharmaceuticals, LLC