BOXED WARNING SECTION.
WARNING: Ingestion of more than 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 patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.
CONTRAINDICATIONS: PrimaCare(TM) is contraindicated in patients with known hypersensitivity to any of the ingredients.
DESCRIPTION: PrimaCare(TM) is prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color and imprinted with PRIMA on one side and blank on the other.PrimaCare(TM) contains flaxseed oil, fish oil and soy.OTHER INGREDIENTS: Gelatin capsule (bovine gelatin, sorbitol, glycerin, purified water, titanium dioxide, FD&C Red 40, caramel coloring, FD&C Blue 1), yellow beeswax and soy lecithin.. image description.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directedby physician.
HOW SUPPLIED SECTION.
HOW SUPPLIED: Bottles of 30 softgels (75854-322-30). The listed product number is not National Drug Code. Instead, Avion Pharmaceuticals has assigned product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.
INDICATIONS & USAGE SECTION.
INDICATIONS: PrimaCare(TM) is multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of omen throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRECAUTIONS: Folic acid alone is improper therapy inthe treatment of pernicious anemia and othermegaloblastic anemias where Vitamin B12 is deficient.Folic acid in doses above 1.0 mg daily may obscurepernicious anemia in that hematologic remission canoccur while neurological manifestations progress.
SPL UNCLASSIFIED SECTION.
MANUFACTURED FOR:Avion Pharmaceuticals, LLCAlpharetta, Georgia 30022 1-888-61-AVIONRev. 1016-06 AV-427THESE STATEMENTS HAVE NOT BEENEVALUATED BY THE FOOD AND DRUGADMINISTRATION. THIS PRODUCT IS NOTINTENDED TO DIAGNOSE, TREAT, CURE ORPREVENT ANY DISEASE.
STORAGE AND HANDLING SECTION.
STORAGE: Store at 20 25C (68 77F); excursions permitted to 15 30C (59 86F) [See USP Controlled Room Temperature.]KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Quatrefolic(R) is registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent 7,947,662 CAS 1181972-37-1 Sumalate(R) is 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.
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.