{"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 known hypersensitivity to any of the ingredients including fish or fish oil."],"description":["DESCRIPTION CAVAN-EC SOD DHA with enteric-coated omega-3 is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acids, supplied as tablets and enteric-coated softgel capsules. Each yellow oval Cavan-EC SOD DHA Tablet contains: VITAMINS A (beta carotene) 3,000 IU C (ascorbic acid) 130 mg D (cholecalciferol) 410 IU E (dl-alpha tocopheryl acetate) 30 mg B 1 (thiamine mononitrate) 1.8 mg B 2 (riboflavin) 4 mg Niacinamide 20 mg B 6 (pyridoxine hydrochloride) 28 mg Folic acid 1 mg B 12 (cyanocobalamin) 12 mcg MINERALS Calcium (calcium carbonate) 230 mg Iron (sodium iron EDTA) 30 mg Magnesium (magnesium oxide) 25 mg Zinc (zinc oxide) 26 mg Copper (cupric oxide) 2 mg Each clear oval enteric-coated DHA Softgel Capsule contains a clear solution with at least 440 mg purified omega-3 long-chain fatty acids including DHA (docosahexaenoic acid), EPA (eicosapentaenoic acid) and DPA (docasapentaenoic acid) in at least 628 mg of fish oil. OMEGA-3 FATTY ACIDS Total omega-3 long chain fatty acids at least 440 mg As DHA at least 295 mg As other omega-3 long-chain fatty acids at least 145 mg OTHER INGREDIENTS (Cavan-EC SOD DHA Tablet): Microcrystalline Cellulose, Corn Starch, Fumed Silica, Magnesium Stearate, Croscarmellose Sodium, PVP-K30 (Kollidon 30), Gum Arabic EQ, Ascorbyl Palmitate, Di Cal Phosphate, Sodium Ascorbate, Hypromellose, Polyethylene Glycol, Polysorbate 80, Titanium Dioxide, Talc, Carnauba Wax, FD&C Yellow #5, FD&C Blue #1. OTHER INGREDIENTS (Cavan-EC SOD DHA Softgel Capsule): Ethyl Vanillin, Gelatine, Glycerine, Purified Water, Sodium Alginate, Stearic Acid, Shellac ammonium salt, specialty denatured alcohol, Acetylated Monoglycerides, Polysobate 80, Potassium Sorbate."],"description_table":["
VITAMINS
A (beta carotene) 3,000 IU
C (ascorbic acid) 130 mg
D (cholecalciferol) 410 IU
E (dl-alpha tocopheryl acetate) 30 mg
B1 (thiamine mononitrate) 1.8 mg
B2 (riboflavin) 4 mg
Niacinamide 20 mg
B6 (pyridoxine hydrochloride) 28 mg
Folic acid 1 mg
B12 (cyanocobalamin) 12 mcg
MINERALS
Calcium (calcium carbonate) 230 mg
Iron (sodium iron EDTA) 30 mg
Magnesium (magnesium oxide) 25 mg
Zinc (zinc oxide) 26 mg
Copper (cupric oxide) 2 mg
","
OMEGA-3 FATTY ACIDS
Total omega-3 long chain fatty acids at least 440 mg
As DHA at least 295 mg
As other omega-3 long-chain fatty acids at least 145 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Before, during and after pregnancy, one tablet and one enteric-coated softgel capsule taken by mouth daily, or as directed by a physician. The tablet and enteric-coated softgel capsule may be taken together or at different times of the day. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day."],"drug_interactions":["DRUG INTERACTIONS Pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized."],"effective_time":"20160817","how_supplied":["HOW SUPPLIED NDC 13925-122-60. Cavan-EC SOD DHA is supplied in child-resistant blister cards containing 30 doses per carton (1 Cavan-EC SOD DHA tablet and 1 enteric-coated DHA softgel capsule equals 1 daily dose). Each unit-of-use dispensing carton contains 6 cards with 5 unit-doses per card which is a 30-day supply. The yellow oval Cavan-EC SOD DHA tablet is imprinted with “S122.” STORAGE Store at controlled room temperature 20-25 ° C (68-77 ° F). Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration of the tablet. DISPENSING Keep in a well-closed, light-resistant container as defined by the USP. Unit dose blisters are child-resistant to opening as a safeguard against ingestion by children. 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 Manufactured For: Seton Pharmaceuticals Manasquan, NJ 08736 MADE IN CANADA SETON PHARMACEUTICALS"],"id":"dd115abe-8824-4fc3-b9cf-0209a934037f","indications_and_usage":["INDICATIONS Cavan-EC SOD DHA is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. Cavan-EC SOD DHA is also useful in improving nutritional status prior to conception."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY NDC 13925 -122- 60 Cavan-EC SOD DHA PRENATAL VITAMINS Enteric-Coated: R x Only 30-Day Supply 30 Tablets and 30 Softgel Capsules Carton Label"],"precautions":["PRECAUTIONS Folic acid in doses above 0.1 mg daily may obscure the diagnosis of pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive)."],"set_id":"0f2053f1-fd94-4a4a-b803-bca391d9e032","spl_product_data_elements":["Cavan-EC SOD DHA Beta Carotene, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, DL-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Iron, Magnesium Oxide, Zinc Oxide, Cupric Oxide, Iodine, Omega-3 Fatty Acids Cavan-EC SOD DHA Beta Carotene, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, DL-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Iron, Magnesium Oxide, Zinc Oxide, Cupric Oxide .BETA.-CAROTENE .BETA.-CAROTENE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL .ALPHA.-TOCOPHEROL THIAMINE MONONITRATE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CALCIUM SODIUM FEREDETATE FERRIC CATION MAGNESIUM MAGNESIUM ZINC ZINC COPPER COPPER CELLULOSE, MICROCRYSTALLINE STARCH, CORN SILICON DIOXIDE MAGNESIUM STEARATE CROSCARMELLOSE SODIUM POVIDONE K30 ACACIA ASCORBYL PALMITATE SODIUM ASCORBATE HYPROMELLOSES POLYETHYLENE GLYCOLS POLYSORBATE 80 TITANIUM DIOXIDE TALC CARNAUBA WAX FD&C YELLOW NO. 5 FD&C BLUE NO. 1 YELLOW OVAL S122 Cavan-EC SOD DHA OMEGA-3 FATTY ACIDS OMEGA-3 FATTY ACIDS OMEGA-3 FATTY ACIDS ETHYL VANILLIN Gelatin Glycerin Water SODIUM ALGINATE STEARIC ACID SHELLAC ALCOHOL DIACETYLATED MONOGLYCERIDES CAPRYLIC/CAPRIC MONO/DIGLYCERIDES POLYSORBATE 80 FISH OIL FISH OIL POTASSIUM SORBATE yellow"],"spl_unclassified_section":["PRENATAL VITAMIN Rx Only","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."],"storage_and_handling":["STORAGE Store at controlled room temperature 20-25 ° C (68-77 ° F). Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration of the tablet."],"version":"4","warnings":["WARNINGS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient."]}