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Prenate Elite Package Insert

Status:
Prescription (Rx) Boxed warning Facts
Strength:
780 mcg, 75 mg, 15 mcg, 18 mg, 3 mg, 3.5 mg, 21 mg, 21 mg, 400 mcg, 600 mcg, 160 mg, 20 mg, 13 mcg, 330 mcg, 150 mcg, 25 mg, 15 mg, 1.5 mg
Drug class:
Active ingredients:
Similar drugs:

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

Prescribing information (package insert) - Prenate Elite

Rx Only Dietary Supplement

DESCRIPTION: PRENATE ELITE ® is a white, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with “PN” on one side and blank on the other. Contains no ingredient made from gluten-containing grain (wheat, barley, or rye).

OTHER INGREDIENTS: Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid. Film Coating (Hypromellose, Titanium Dioxide,Triacetin).

INDICATIONS: PRENATE ELITE ® 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 ELITE ® is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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. Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic test (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.

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 tablet daily or as directed by a physician.

HOW SUPPLIED: Bottles of 30 tablets (75854-314-30). 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

L-0307 Rev. 0325-03

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 Elite

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, Copper Absorption Inhibitor, Folate Analog, Osmotic Laxative, Phosphate Binder, Vitamin A, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Vitamin A 780 mcg, Ascorbic acid 75 mg, Cholecalciferol 15 mcg, Alpha-tocopherol acetate, DL- 18 mg, Thiamine mononitrate 3 mg, Riboflavin 3.5 mg, Niacinamide 21 mg, Pyridoxine hydrochloride 21 mg, Folic acid 400 mcg, Levomefolate calcium 600 mcg, Calcium formate 160 mg, Ferrous asparto glycinate 20 mg, Cyanocobalamin 13 mcg, Biotin 330 mcg, Potassium iodide 150 mcg, Magnesium oxide 25 mg, Zinc oxide 15 mg, Cupric oxide 1.5 mg
Dosage form Tablet, coated
Route Oral
Marketing status not in the current 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
780 mcg, 75 mg, 15 mcg, 18 mg, 3 mg, 3.5 mg, 21 mg, 21 mg, 400 mcg, 600 mcg, 160 mg, 20 mg, 13 mcg, 330 mcg, 150 mcg, 25 mg, 15 mg, 1.5 mg – 30 in 1 bottle NDC 75854-314-30

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.