Label: PRENATE MINI- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, cya...view full title
- NDC Code(s): 75854-315-30
- Packager: Avion Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 23, 2024
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SPL UNCLASSIFIED SECTIONRx Only Dietary Supplement
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DESCRIPTIONDESCRIPTION: 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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INACTIVE INGREDIENTOTHER INGREDIENTS: Bovine gelatin, FD&C Blue #1, FD&C Yellow #5, fish (tuna) oil, glycerin, purified water, soy lecithin, titanium dioxide, vegetable shortening and yellow beeswax.
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INDICATIONS & USAGEINDICATIONS: 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 ...
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CONTRAINDICATIONSCONTRAINDICATIONS: PRENATE MINI - ® is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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BOXED WARNING
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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.
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PRECAUTIONSPRECAUTIONS: 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 ...
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BOXED WARNING
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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.
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ADVERSE REACTIONSADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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DOSAGE & ADMINISTRATIONDOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.
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HOW SUPPLIEDHOW 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 ...
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STORAGE AND HANDLINGSTORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
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SPL UNCLASSIFIED SECTIONMANUFACTURED FOR: Avion Pharmaceuticals, LLC - Alpharetta, GA 30005 - 1-888-61-AVION - Rev. 0519-01 - Sumalate - ® is a registered trademark of Albion Laboratories,Inc., covered by one or more claims of ...
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SPL UNCLASSIFIED SECTIONTHESE 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 ...
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL75854-0315-30 - Rx Only Dietary Supplement - Prenate mini - ® A small, easy-to-swallow - softgel with complete prenatal - nutrition support, including - 350 mg of DHA - 30 ...
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INGREDIENTS AND APPEARANCEProduct Information