{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates – including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin."],"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 or fish oil."],"description":["DESCRIPTION Cavan™-Folate DHA is a prescription prenatal/postnatal multivitamin/mineral tablet and a softgel with an essential fatty acid. Each tablet has the following active ingredient: Vitamin B 9 1 mg Each tablet also contains the following ingredients for nutritional supplementation: Vitamin A (beta carotene) 2700 IU Vitamin D (cholecalciferol) 400 IU Vitamin C (ascorbic acid) 70 mg Vitamin E (dl-alpha tocopheryl acetate) 30 IU Vitamin B 1 (thiamine mononitrate) 1.6 mg Vitamin B 2 (riboflavin) 1.8 mg Vitamin B 6 (pyridoxine hydrochloride) 2.5 mg Vitamin B 12 (cyanocobalamin) 12 mcg Niacin (niacinamide) 18 mg Calcium (calcium carbonate) 100 mg Elemental Iron (ferrous fumarate) 65 mg Magnesium (magnesium oxide) 25 mg Zinc (zinc oxide) 25 mg Copper (copper oxide) 2 mg Each softgel has the following active ingredient: Docosahexaenoic Acid (DHA) 250 mg Derived from at least 310 mg purified Fish Oil."],"description_table":["
Each tablet has the following active ingredient:
Vitamin B9 1 mg
Each tablet also contains the following ingredients for nutritional supplementation:
Vitamin A (beta carotene) 2700 IU
Vitamin D (cholecalciferol) 400 IU
Vitamin C (ascorbic acid) 70 mg
Vitamin E (dl-alpha tocopheryl acetate) 30 IU
Vitamin B1 (thiamine mononitrate) 1.6 mg
Vitamin B2 (riboflavin) 1.8 mg
Vitamin B6 (pyridoxine hydrochloride) 2.5 mg
Vitamin B12 (cyanocobalamin) 12 mcg
Niacin (niacinamide) 18 mg
Calcium (calcium carbonate) 100 mg
Elemental Iron (ferrous fumarate) 65 mg
Magnesium (magnesium oxide) 25 mg
Zinc (zinc oxide) 25 mg
Copper (copper oxide) 2 mg
Each softgel has the following active ingredient:
Docosahexaenoic Acid (DHA) 250 mgDerived from at least 310 mg purified Fish Oil.
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Before, during and after pregnancy, one tablet and one softgel capsule daily, or as directed by a physician."],"effective_time":"20120810","general_precautions":["General: Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B 12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B 12 deficiency. Folate therapy alone is inadequate for the treatment of B 12 deficiency."],"how_supplied":["HOW SUPPLIED Cavan™-Folate DHA is supplied in child-resistant blister packs of 30 tablets and 30 softgels. The Cavan™-Folate DHA tablet is an oblong, blue coated tablet with \"S124\" debossed on one side. The DHA softgel is an oblong, clear softgel capsule. NDC 13925-125-60"],"id":"9074a143-908f-461c-9665-c14c4355835f","inactive_ingredient":["Inactive Ingredients: PVP K30, Sodium Phosphate Dibasic, Potassium Chloride, Fumed Silica, Citric Acid, TriPotassium Citrate, Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium Stearate, Stearic Acid, Gum Arabic, Carboxylmethyl Cellulose, Prosolv™, Maltodextrin, Silicon Dioxide, Pregelatinized Starch, Hypromellose, Polyethylene Glycol, Ethyl Cellulose, Titanium Dioxide, Talc, FD&C Blue #1, Vegetable Oil, Polysorbate 80, Vitamin E, Natural Creamy Orange Flavor, Gelatin, Glycerin and Purified Water."],"indications_and_usage":["INDICATIONS AND USAGE Cavan™-Folate DHA is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL: NDC 13925- 125- 60 Cavan TM - Folate DHA Tablets/Softgels R x Only 30-Day Supply 30 Tablets / 30 Softgels SETON PHARMACEUTICALS Container Label"],"patient_medication_information":["PATIENT INFORMATION Cavan™-Folate DHA is a prescription vitamin for use only under the direction and supervision of a licensed physician."],"precautions":["CAUTION Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.","PRECAUTIONS"],"set_id":"9074a143-908f-461c-9665-c14c4355835f","spl_product_data_elements":["Cavan Folate DHA FOLIC ACID, .BETA.-CAROTENE, CHOLECALCIFEROL, ASCORBIC ACID, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, NIACINAMIDE, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE and DOCONEXENT Cavan Folate DHA FOLIC ACID, .BETA.-CAROTENE, CHOLECALCIFEROL, ASCORBIC ACID, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, NIACINAMIDE, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE and DOCONEXENT FOLIC ACID FOLIC ACID .BETA.-CAROTENE .BETA.-CAROTENE CHOLECALCIFEROL CHOLECALCIFEROL ASCORBIC ACID ASCORBIC ACID .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- THIAMINE MONONITRATE THIAMINE ION RIBOFLAVIN RIBOFLAVIN PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CYANOCOBALAMIN NIACINAMIDE NIACINAMIDE CALCIUM CARBONATE CALCIUM CATION FERROUS FUMARATE FERROUS CATION MAGNESIUM OXIDE MAGNESIUM CATION ZINC OXIDE ZINC OXIDE CUPRIC OXIDE CUPRIC OXIDE DOCONEXENT DOCONEXENT POVIDONE K30 SODIUM PHOSPHATE, DIBASIC POTASSIUM CHLORIDE SILICON DIOXIDE CITRIC ACID MONOHYDRATE POTASSIUM CITRATE ANHYDROUS CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE STEARIC ACID ACACIA CARBOXYMETHYLCELLULOSE CALCIUM CELLULOSE, MICROCRYSTALLINE MALTODEXTRIN SILICON DIOXIDE STARCH, CORN HYPROMELLOSES POLYETHYLENE GLYCOLS ETHYLCELLULOSES TITANIUM DIOXIDE TALC FD&C BLUE NO. 1 CORN OIL POLYSORBATE 80 .ALPHA.-TOCOPHEROL GELATIN GLYCERIN WATER S124 Cavan Folate DHA MULTI-VITAMIN/MINERAL SUPPLEMENT FOLIC ACID FOLIC ACID .BETA.-CAROTENE .BETA.-CAROTENE CHOLECALCIFEROL CHOLECALCIFEROL ASCORBIC ACID ASCORBIC ACID .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- THIAMINE MONONITRATE THIAMINE ION RIBOFLAVIN RIBOFLAVIN PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CYANOCOBALAMIN NIACINAMIDE NIACINAMIDE CALCIUM CARBONATE CALCIUM CATION FERROUS FUMARATE FERROUS CATION MAGNESIUM OXIDE MAGNESIUM CATION ZINC OXIDE ZINC OXIDE CUPRIC OXIDE CUPRIC OXIDE DOCONEXENT DOCONEXENT POVIDONE K30 SODIUM PHOSPHATE, DIBASIC POTASSIUM CHLORIDE SILICON DIOXIDE CITRIC ACID MONOHYDRATE POTASSIUM CITRATE ANHYDROUS CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE STEARIC ACID ACACIA CARBOXYMETHYLCELLULOSE CALCIUM MALTODEXTRIN SILICON DIOXIDE STARCH, CORN HYPROMELLOSES POLYETHYLENE GLYCOLS ETHYLCELLULOSES TITANIUM DIOXIDE TALC FD&C BLUE NO. 1 CORN OIL POLYSORBATE 80 .ALPHA.-TOCOPHEROL GELATIN GLYCERIN WATER clear"],"spl_unclassified_section":["Tablets/Softgels R x Only","This product contains fish oil.","Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. R x Only Reserved for Professional Recommendation All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence. Manufactured For: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 MADE IN CANADA 06/10 SETON PHARMACEUTICALS"],"storage_and_handling":["STORAGE Store at controlled room temperature 15°C to 30°C (59°F to 86°F). Avoid excessive heat."],"version":"1","warnings":["WARNINGS Daily ingestion of more than 3 g per day of omega-3 fatty acids (ALA, EPA, and DHA) from fish oils may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids − including DHA, should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.","INTERACTIONS Drugs which may interact with folate include: Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of this AED in the blood and allowing breakthrough seizures to occur. Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine. Cholestyramine: Reduces folic acid absorption and reduces serum folate levels. Colestipol: Reduces folic acid absorption and reduces serum folate levels. Cycloserine: Reduces folic acid absorption and reduces serum folate levels. Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim. Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine. Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin. Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac. Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy. Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone. Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts. Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine. Smoking and Alcohol: Reduced serum folate levels have been noted. Sulfasalazine: Inhibits the absorption and metabolism of folic acid. Metformin treatment in patients with type 2 diabetes decreases serum folate. Warfarin can produce significant impairment in folate status after a 6-month therapy. Drugs which may interact with pyridoxine hydrochloride: Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa"]}