Medication-info.com Search Menu

Prenate Mini Package Insert

Status:
Prescription (Rx) Boxed warning Facts
Strength:
280 mcg, 80 mg, 5 mg, 13 mg, 150 mcg, 25 mg, 350 mg, 25 mg, 600 mcg, 60 mg, 25 mcg, 4.5 mg, 26 mg, 400 mcg, 13 mcg
Drug class:
Active ingredients:
Similar drugs:

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

Prescribing information (package insert) - Prenate Mini

Rx Only Dietary Supplement

DESCRIPTION: PRENATE MINI® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each oval softgel is teal green in color and imprinted with “Mini”. Contains no ingredient made from a gluten containing grain (wheat, barley or rye).

Contains fish oil and soy.

OTHER INGREDIENTS: Beeswax, bovine gelatin, FD&C Blue #1, FD&C Yellow #5, fish (tuna) oil, glycerin, purified water, soy lecithin, titanium dioxide and vegetable shortening.

INDICATIONS: PRENATE MINI ® 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 MINI ® 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.

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.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

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 (75854-0315-30). 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

Alpharetta, GA 30005

1-888-61-AVION

L-0245 Rev. 0325-03

Sumalate ® is a registered trademark of Albion Laboratories,Inc., covered by one or more claims of U.S. Patent Nos. 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

Found a mistake? Write to us via the contact page.

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

Drug information for Prenate Mini

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 Biotin 280 mcg, Calcium carbonate 80 mg, Ferrous asparto glycinate 5 mg, Iron 13 mg, Potassium iodide 150 mcg, Magnesium oxide 25 mg, Doconexent 350 mg, Lowbush blueberry 25 mg, Levomefolate calcium 600 mcg, Ascorbic acid 60 mg, Cholecalciferol 25 mcg, Alpha-tocopherol acetate, DL- 4.5 mg, Pyridoxine hydrochloride 26 mg, Folic acid 400 mcg, Cyanocobalamin 13 mcg
Dosage form Capsule, gelatin 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
280 mcg, 80 mg, 5 mg, 13 mg, 150 mcg, 25 mg, 350 mg, 25 mg, 600 mcg, 60 mg, 25 mcg, 4.5 mg, 26 mg, 400 mcg, 13 mcg – 30 in 1 bottle NDC 75854-315-30

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.