Prenate Essential
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent · Capsule, Gelatin Coated · Oral
Uses
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.
Dosage and administration
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.
Contraindications
CONTRAINDICATIONS: PRENATE ESSENTIAL ® is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Warnings
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
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.
Side effects
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Description
DESCRIPTION: PRENATE ESSENTIAL® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is dark green in color, opaque, and imprinted with “Prenate” on one side and blank on the other. PRENATE ESSENTIAL® contains fish oil and soy. Prenate Essential Supplement Facts Panel OTHER INGREDIENTS: Capsule gelatin (gelatin, sorbitol, glycerin, purified water, turmeric, and sodium copper chlorophyllin), soy lecithin, white beeswax and soybean oil.
How supplied
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
STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
Label text from the FDA structured product label by Avion Pharmaceuticals, LLC (revised Jun 12, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Icosapent in 1 product
- Ascorbic Acid in 1 product
- Cholecalciferol in 1 product
- .alpha.-tocopherol Acetate, Dl- in 1 product
- Pyridoxine Hydrochloride in 1 product
- Folic Acid in 1 product
- Levomefolate Calcium in 1 product
- Cyanocobalamin in 1 product
- Biotin in 1 product
- Calcium Formate in 1 product
- Ferrous Asparto Glycinate in 1 product
- Potassium Iodide in 1 product
Prenate Essential NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 75854-313 | Icosapent 40 mg/1; Ascorbic Acid 90 mg/1; Cholecalciferol 5.5 ug/1; .alpha.-tocopherol Acetate, Dl- 4.5 mg/1;… Capsule, Gelatin Coated | Avion Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Prenate Essential used for?
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.
What are the side effects of Prenate Essential?
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid. See the full label for the complete list.
Who makes Prenate Essential?
Prenate Essential is listed by 1 labeler in the FDA NDC directory, including Avion Pharmaceuticals, LLC.