Generic Name: prenatal/postnatal multivitamin/mineral/essential fatty acids
Dosage Form: capsule, gelatin coated
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 Essential® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is green in color, opaque, and imprinted with 'Prenate' on one side and blank on the other.
Serving Size: 1 Softgel
|Amount per Serving:||% Daily Value||% Daily
|Vitamin C (as ascorbic acid)||90 mg||150%||150%|
|Vitamin D3 (as cholecalciferol)||220 IU||55%||55%|
|Vitamin E (as dl-alpha tocopheryl acetate)||10 IU||33%||33%|
|Vitamin B6 (as pyridoxine HCl)||26 mg||1300%||1040%|
|Folate (as ((6S)-N5-methyltetrahydrofolic acid calcium salt (molar equivalent to 600 mcg of folic acid) and folic acid, USP 400 mcg)||1 mg||250%||125%|
|Vitamin B12 (as cyanocobalamin)||13 mcg||217%||163%|
|Calcium (as calcium formate) Formical®||155 mg||16%||12%|
|Iron (as ferrous asparto glycinate) Sumalate®||18 mg||100%||100%|
|Iodine (as potassium iodine)||150 mcg||100%||100%|
|Magnesium (as magnesium oxide)||50 mg||13%||11%|
|Docosahexaenoic acid (DHA)||300 mg||*||*|
|Eicosapentaenoic acid (EPA)||40 mg||*||*|
Prenate Essential® contains fish oil and soy.
OTHER INGREDIENTS: Bovine gelatin, glycerin, soy lecithin, white beeswax, purified water, soybean oil, titanium dioxide, FD&C yellow #5, FD&C Blue #1, and FD&C yellow #6.
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 B12 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.]
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.
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 Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.
Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30022
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Rx prenatal vitamin & DHA Essential®
• Key vitamins, minerals, and DHA support nutrition
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent capsule, gelatin coated
|Labeler - Avion Pharmaceuticals, LLC (965450542)|