Prenate Mini
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.
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Rx Only Prenatal 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”.
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| Supplement Facts Serving Size: 1 Softgel |
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| Amount per Serving: | % Daily Value |
% Daily Value (Pregnant & Lactating Women) |
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| Vitamin C (as ascorbic acid) |
60 mg | 100% | 100% |
| Vitamin D 3 (as cholecalciferol) |
1000 IU | 250% | 250% |
| Vitamin E (as dl-alpha tocopherol) |
10 IU | 33% | 33% |
| Vitamin B 6 (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 B 12 (as cyanocobalamin) | 13 mcg | 217% | 163% |
| Biotin | 280 mcg | 93% | 93% |
| Calcium (as calcium carbonate) |
80 mg | 8% | 6% |
| Iron (as ferrous asparto glycinate) Sumalate ® and (carbonyl iron) - Ferronyl ® | 18 mg | 100% | 100% |
| Iodine (as potassium iodide) |
150 mcg | 100% | 100% |
| Magnesium (as magnesium oxide) | 25 mg | 6% | 6% |
| Docosahexaenoic Acid (DHA) |
350 mg | * | * |
| Blueberry extract (vaccinium spp.) |
25 mg | * | * |
Contains fish oil and soy.
OTHER INGREDIENTS: Fish (tuna) oil, bovine gelatin, glycerin, soy lecithin, yellow beeswax, purified water, vegetable shortening, FD&C Blue #1, titanium dioxide and FD&C Yellow #5.
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.
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.
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.
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 AND HANDLING SECTION: 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.
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.
Ferronyl ® is a registered trademark of ISP Investments, Inc.
PRENATE ® is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.
MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30022
1-888-61-AVION
Rev. 1114
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
75854-0315-30
Prenate mini
A small, easy-to-swallow
softgel with complete prenatal
nutrition support, including
350 mg of DHA
30 Softgels
Rx Only
Prenatal Supplement
GLUTEN FREE
LACTOSE FREE
Avion
PHARMACEUTICALS
| Prenate Mini ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous asparto glycinate, iron, potassium iodide, magnesium oxide, doconexent and lowbush blueberry capsule, gelatin coated |
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| Labeler - Avion Pharmaceuticals, LLC (965450542) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Avion Pharmaceuticals, LLC | 965450542 | manufacture(75854-315) | |
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