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Prenate Essential Package Insert

Status:
Prescription (Rx) Boxed warning Facts
Strength:
40 mg, 90 mg, 5.5 mcg, 4.5 mg, 26 mg, 400 mcg, 600 mcg, 13 mcg, 280 mcg, 160 mg, 18 mg, 150 mcg, 50 mg, 300 mg
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Prenate Essential

Rx Only

Dietary Supplement

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.

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

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

L-0448 Rev. 0525-01

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.

PRENATE ® is a registered trademark of Avion Pharmaceuticals, LLC. All rights reserved.

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.

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Prenate Essential

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Blood Coagulation Factor, Calculi Dissolution Agent, Folate Analog, Osmotic Laxative, Phosphate Binder, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Icosapent 40 mg, Ascorbic acid 90 mg, Cholecalciferol 5.5 mcg, Alpha-tocopherol acetate, DL- 4.5 mg, Pyridoxine hydrochloride 26 mg, Folic acid 400 mcg, Levomefolate calcium 600 mcg, Cyanocobalamin 13 mcg, Biotin 280 mcg, Calcium formate 160 mg, Ferrous asparto glycinate 18 mg, Potassium iodide 150 mcg, Magnesium oxide 50 mg, Doconexent 300 mg
Dosage form Capsule, gelatin coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) Avion Pharmaceuticals, LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
40 mg, 90 mg, 5.5 mcg, 4.5 mg, 26 mg, 400 mcg, 600 mcg, 13 mcg, 280 mcg, 160 mg, 18 mg, 150 mcg, 50 mg, 300 mg – 30 in 1 bottle NDC 75854-313-30

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.