Generic Name: ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, iron pentacarbonyl, potassium iodide, magnesium oxide, doconexent and lowbush blueberry
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.
A complete Rx prenatal vitamin that's easy to swallow
DESCRIPTION: Prenate Mini™ is a yellow, oval multivitamin/multimineral softgel imprinted with “mini” on one side and blank on the other.
Serving Size: 1 Softgel
|Amount per Serving:||% Daily Value||% Daily Value for
|Vitamin C (as ascorbic acid)||60 mg||100%||100%|
|Vitamin D3 (as cholecalciferol)||220 IU||55%||55%|
|Vitamin E (as dl-alpha tocopherol)||10 IU||33%||33%|
|Vitamin B6 (as pyridoxine HCl)||26 mg||1300%||1040%|
(as 1.1 mg Quatrefolic® ((6S)-5,methyltetrahydrofolate glucosamine salt* CAS 1181972-37-1) molar equivalent to 600 mcg of Folic Acid) (folic acid, USP 400 mcg)
|Vitamin B12 (as cyanocobalamin)||13 mcg||217%||163%|
|Calcium (as calcium carbonate)||100 mg||10%||8%|
|Iron (as iron carbonyl)||29 mg||161%||161%|
|Iodine (as potassium iodide)||150 mcg||100%||100%|
|Magnesium (as magnesium oxide)||25 mg||6%||6%|
|Docosahexaenoic Acid (DHA)||350 mg||*||*|
|Blueberry Extract (vaccinium angustifolium)||25 mg||*||*|
Prenate Mini™ contains fish oil and soy.
OTHER INGREDIENTS: fish oil, gelatin, glycerin, purified water, beeswax, soy lecithin, hydrogenated vegetable oil, titanium dioxide, and tumeric powder.
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.
Prenate Mini™ can also be beneficial in improving the nutritional status of women prior to conception.
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 B12 is deficient. Folic acid in doses above 0.1 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: Prenate Mini™ is supplied in child-resistent bottles of 30 softgels. (75854-304-30).
The listed product number is not a National Drug Code, but has instead merely been formatted to comply with standard industry practice for pharmacy and 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
Atlanta, GA 30350
*Quatrefolic® is a registered trademark of Gnosis, SpA.Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1
Prenate Mini™ is a registered trademark of Acella Pharmaceuticals, LLC.
Under license from Acella Pharmaceuticals, LLC.
All rights reserved.
To learn more about your pregnancy, go to www.PrenatePERL.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
A complete Rx prenatal vitamin that’s easy to swallow
Atlanta, GA 30350
Prenate Mini™ is a trademark of Acella Pharmaceuticals, LLC.
*Quatrefolic® is a registered trademark of Gnosis, SpA.
Under license from Acella Pharmaceuticals LLC
All rights reserved.
ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, iron pentacarbonyl, potassium iodide, magnesium oxide, doconexent and lowbush blueberry capsule, gelatin coated
|Labeler - Avion Pharmaceuticals, LLC (965450542)|