{"adverse_reactions":["Adverse Reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"boxed_warning":["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."],"contraindications":["CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients including fish and fish oil."],"description":["DESCRIPTION: Cavan One Omega is a prescription prenatal/postnatal multivitamin/mineral capsule with omega-3 fatty acids. Each maroon soft gelatin capsule for oral administration contains: Essential Fatty Acids: Omega-3 Fatty Acids 330 mg Docosahexaenoic Acid (DHA) 260 mg Eicosapentaenoic Acid (EPA) 40 mg α-Linolenic Acid (ALA) 30 mg Linoleic Acid 30 mg Vitamins: Vitamin C Complex Vitamin C Complex is a pharmaceutical grade material consisting of calcium ascorbate and calcium threonate. (as calcium ascorbate and calcium threonate) 25 mg Vitamin D 3 (cholecalciferol) 170 IU Vitamin E (dl-alpha-tocopheryl acetate) 30 IU Folic Acid, USP 1 mg Vitamin B 6 (pyridoxine hydrochloride) 25 mg Minerals: Calcium 150 mg Iron Carbonyl iron (elemental iron) 20 mg Iron (ferrous aspartate and ferrous glycinate) 7 mg"],"description_table":["
Essential Fatty Acids:
Omega-3 Fatty Acids 330 mg
Docosahexaenoic Acid (DHA) 260 mg
Eicosapentaenoic Acid (EPA) 40 mg
α-Linolenic Acid (ALA) 30 mg
Linoleic Acid 30 mg
Vitamins:
Vitamin C ComplexVitamin C Complex is a pharmaceutical grade material consisting of calcium ascorbate and calcium threonate. (as calcium ascorbate and calcium threonate) 25 mg
Vitamin D3 (cholecalciferol) 170 IU
Vitamin E (dl-alpha-tocopheryl acetate) 30 IU
Folic Acid, USP 1 mg
Vitamin B6 (pyridoxine hydrochloride) 25 mg
Minerals:
Calcium 150 mg
Iron
Carbonyl iron (elemental iron) 20 mg
Iron (ferrous aspartate and ferrous glycinate) 7 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Usual dosage is one capsule daily, or as prescribed by a physician."],"effective_time":"20120725","geriatric_use":["Geriatric Use: Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy."],"how_supplied":["HOW SUPPLIED: Cavan One Omega prenatal/postnatal multivitamin/mineral oblong capsules are maroon soft gelatin capsules, imprinted “TL049”, packaged in bottles of 30 capsules (NDC 13925-080-30)."],"id":"4617515b-7b01-4c53-82ae-9edaff93905a","inactive_ingredient":["Inactive Ingredients: Aspartic Acid, Carmine Hydrosoluble, Citric Acid, FD&C Blue#1, FD&C Red#40, Fumed Silica, Gelatin, Glycerin, Lecithin, Purified Water, Sorbic Acid, Titanium Dioxide, Vanillin and Yellow Bees Wax."],"indications_and_usage":["INDICATIONS: Cavan One Omega is indicated to provide vitamin/mineral and omega-3 fatty acid supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. It is also useful for improving nutritional status prior to conception."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL: NDC 13925- 080 -30 Cavan One Omega Prenatal Vitamin Supplement with DHA & EPA and 1 mg Folic Acid 30 Softgel Capsules R x Only SETON PHARMACEUTICALS Container Label"],"pediatric_use":["Pediatric Use: Safety and effectiveness in pediatric patients have not been established."],"precautions":["PRECAUTIONS"],"set_id":"4617515b-7b01-4c53-82ae-9edaff93905a","spl_product_data_elements":["Cavan One Omega-3 Fatty Acids, Doconexent, Icosapent, Linolenic Acid, Linoleic Acid, Calcium Ascorbate, Calcium Threonate, Cholecalciferol, .Alpha.-Tocopherol Acetate, DL-, Pyridoxine Hydrochloride, Folic Acid, Calcium, Iron and Ferrous Asparto Glycinate DOCONEXENT DOCONEXENT ICOSAPENT ICOSAPENT LINOLENIC ACID LINOLENIC ACID LINOLEIC ACID LINOLEIC ACID CALCIUM ASCORBATE ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- FOLIC ACID FOLIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CALCIUM CALCIUM IRON IRON FERROUS ASPARTO GLYCINATE FERROUS CATION ASPARTIC ACID PIGMENT RED 48 CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 SILICON DIOXIDE GELATIN GLYCERIN LECITHIN, SOYBEAN WATER SORBIC ACID TITANIUM DIOXIDE VANILLIN YELLOW WAX TL049"],"spl_unclassified_section":["A once-daily prenatal vitamin supplement, including key omega-3 fatty acids (DHA and EPA) and 1 mg folic acid R x Only","Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN R x Only Reserved for Professional Recommendation Manufactured For: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 12/09 SETON PHARMACEUTICALS"],"storage_and_handling":["Storage: Store at controlled room temperature 15°-30° C (59°-86° F)."],"version":"1","warnings":["WARNINGS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. Since daily ingestion of more than 3 grams per day of omega-3 fatty acids [including alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)] from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants."]}