Label:
PRENATE MINI- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, cya...
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  • NDC Code(s): 75854-315-30
  • Packager: Avion Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated January 23, 2024

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  • SPL UNCLASSIFIED SECTION
    Rx Only Dietary Supplement
  • DESCRIPTION
    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” ...
  • INACTIVE INGREDIENT
    OTHER 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.
  • INDICATIONS & USAGE
    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 ...
  • CONTRAINDICATIONS
    CONTRAINDICATIONS: PRENATE MINI - ® is contraindicated in patients with a known hypersensitivity to any of the ingredients.
  • BOXED WARNING (What is this?)

    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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  • PRECAUTIONS
    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 ...
  • BOXED WARNING (What is this?)

    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 REACTIONS
    ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
  • DOSAGE & ADMINISTRATION
    DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.
  • HOW SUPPLIED
    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 ...
  • STORAGE AND HANDLING
    STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
  • SPL UNCLASSIFIED SECTION
    MANUFACTURED 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 ...
  • SPL UNCLASSIFIED SECTION
    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 ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    75854-0315-30 - Rx Only Dietary Supplement - Prenate mini - ® A small, easy-to-swallow - softgel with complete prenatal - nutrition support, including - 350 mg of DHA - 30 ...
  • INGREDIENTS AND APPEARANCE
    Product Information