{"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 years of age. 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. WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately."],"description":["DESCRIPTION Gesticare ® DHA includes a light pink coated oblong-shaped tablet with “P-114” debossed on one side of the tablet and a natural DHA softgel capsule containing a pale orange oil. Each tablet contains: Vitamin B1 (Thiamin Mononitrate) 3 mg Vitamin B2 (Riboflavin) 3 mg Vitamin B6 (Pyridoxine HCl) 50 mg Vitamin B12 (Cyanocobalamin) 8 µg Vitamin C (Ascorbic acid) 120 mg Niacin (Niacinamide) 20 mg Folic acid 1 mg Iron (Ferrous Fumarate) 27 mg Calcium (Calcium Carbonate) 200 mg Vitamin D3 (Cholecalciferol) 410 IU Vitamin E (DL-Alpha Tocopheryl Acetate) 30 IU Iodine (Potassium Iodide) 150 µg Zinc (Zinc Oxide) 15 mg Choline (Choline Bitartrate) 55 mg Inactive Ingredients: Microcrystalline Cellulose, Maltodextrin, Croscarmellose Sodium, Starch, Citric Acid, Silicon Dioxide, Magnesium Stearate, Stearic Acid, Calcium Sulfate, Bovine Gelatin Hydrolyzed, Sucrose, Partially Hydrogenated Soybean Oil, Dicalcium Phosphate, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc, FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake. Each DHA gelatin capsule contains: DHA is an omega-3 fatty acid . The DHA in Gesticare ® DHA is derived from Algal Oil (C.cohnii). 625 mg of Algal Oil is equivalent to250 mg of DHA. Other ingredients in the DHA gelatin capsule: High Oleic Sunflower Oil, Ascorbyl Palmitate, Tocopherols, Gelatin (Bovine), Glycerin,Polysorbate 80. Docosahexaenoic Acid (DHA) from Algal Oil 250 mg Eicosapentaenoic Acid (EPA) Not more than 0.625mg","Each tablet contains: Vitamin B1 (Thiamin Mononitrate) 3 mg Vitamin B2 (Riboflavin) 3 mg Vitamin B6 (Pyridoxine HCl) 50 mg Vitamin B12 (Cyanocobalamin) 8 µg Vitamin C (Ascorbic acid) 120 mg Niacin (Niacinamide) 20 mg Folic acid 1 mg Iron (Ferrous Fumarate) 27 mg Calcium (Calcium Carbonate) 200 mg Vitamin D3 (Cholecalciferol) 410 IU Vitamin E (DL-Alpha Tocopheryl Acetate) 30 IU Iodine (Potassium Iodide) 150 µg Zinc (Zinc Oxide) 15 mg Choline (Choline Bitartrate) 55 mg","Each DHA gelatin capsule contains: DHA is an omega-3 fatty acid . The DHA in Gesticare ® DHA is derived from Algal Oil (C.cohnii). 625 mg of Algal Oil is equivalent to250 mg of DHA. Other ingredients in the DHA gelatin capsule: High Oleic Sunflower Oil, Ascorbyl Palmitate, Tocopherols, Gelatin (Bovine), Glycerin,Polysorbate 80. Docosahexaenoic Acid (DHA) from Algal Oil 250 mg Eicosapentaenoic Acid (EPA) Not more than 0.625mg"],"description_table":["
Vitamin B1 (Thiamin Mononitrate) 3 mg
Vitamin B2 (Riboflavin) 3 mg
Vitamin B6 (Pyridoxine HCl) 50 mg
Vitamin B12 (Cyanocobalamin) 8 µg
Vitamin C (Ascorbic acid) 120 mg
Niacin (Niacinamide) 20 mg
Folic acid 1 mg
Iron (Ferrous Fumarate) 27 mg
Calcium (Calcium Carbonate) 200 mg
Vitamin D3 (Cholecalciferol) 410 IU
Vitamin E (DL-Alpha Tocopheryl Acetate) 30 IU
Iodine (Potassium Iodide) 150 µg
Zinc (Zinc Oxide) 15 mg
Choline (Choline Bitartrate) 55 mg
","
DHA is an omega-3 fatty acid. The DHA in Gesticare® DHA is derived from Algal Oil (C.cohnii). 625 mg of Algal Oil is equivalent to250 mg of DHA.
Other ingredients in the DHA gelatin capsule: High Oleic Sunflower Oil, Ascorbyl Palmitate, Tocopherols, Gelatin (Bovine), Glycerin,Polysorbate 80.
Docosahexaenoic Acid (DHA) from Algal Oil 250 mg
Eicosapentaenoic Acid (EPA) Not more than 0.625mg
","
Vitamin B1 (Thiamin Mononitrate) 3 mg
Vitamin B2 (Riboflavin) 3 mg
Vitamin B6 (Pyridoxine HCl) 50 mg
Vitamin B12 (Cyanocobalamin) 8 µg
Vitamin C (Ascorbic acid) 120 mg
Niacin (Niacinamide) 20 mg
Folic acid 1 mg
Iron (Ferrous Fumarate) 27 mg
Calcium (Calcium Carbonate) 200 mg
Vitamin D3 (Cholecalciferol) 410 IU
Vitamin E (DL-Alpha Tocopheryl Acetate) 30 IU
Iodine (Potassium Iodide) 150 µg
Zinc (Zinc Oxide) 15 mg
Choline (Choline Bitartrate) 55 mg
","
DHA is an omega-3 fatty acid. The DHA in Gesticare® DHA is derived from Algal Oil (C.cohnii). 625 mg of Algal Oil is equivalent to250 mg of DHA.
Other ingredients in the DHA gelatin capsule: High Oleic Sunflower Oil, Ascorbyl Palmitate, Tocopherols, Gelatin (Bovine), Glycerin,Polysorbate 80.
Docosahexaenoic Acid (DHA) from Algal Oil 250 mg
Eicosapentaenoic Acid (EPA) Not more than 0.625mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One Gesticare ® tablet and one DHA capsule daily or as directed by a physician."],"effective_time":"20120629","how_supplied":["HOW SUPPLIED Gesticare ® DHA 30 count is supplied as six child-resistant blister cards containing 5 Gesticare ® tablets and 5 DHA capsules each (NDC 18860-253-30). Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°- 30ºC (59°-86°F). Do not use if blister seal is broken.","KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. RX only Distributed by: Azur Pharma, Inc. 1818 Market Street, Suite 2350 Philadelphia, PA 19103 To report a serious adverse event or obtain product information, contact (800) 890 3098. Gesticare ® is a registered trademark of Azur Pharma International II Limited. life’s DHA is a trademark of Martek Biosciences Corporation. life's DHA logo"],"id":"31f33d7f-3797-40b8-8388-6e3000977325","indications_and_usage":["INDICATIONS AND USAGE Gesticare ® DHA is indicated to provide vitamin/mineral and DHA omega-3 fatty acid supplement to women throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Gesticare ® DHA may be beneficial in improving the nutritional status of women prior to conception."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Carton label for blister cards Gesti care ® DHA Prenatal Multi-Vitamin/Mineral Tablets with DHA and Choline NDC 18860-253-30 (30 Count) 6 Blister Cards; each containing 5 tablets and 5 capsules Principal Display Panel - Carton Label for Blister Cards","PRINCIPAL DISPLAY PANEL - Carton label for physician’s sample Gesti care ® DHA Prenatal Multi-Vitamin/Mineral Tablets with DHA and Choline Gesticare ® DHA is indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Gesticare ® DHA may be beneficial in improving the nutritional status of women prior to conception. PHYSICIAN'S SAMPLES (NDC 18860-253-00) Contains 6 Patient Starter packages, each containing 2 tablets and 2 capsules One tablet and one capsule daily or as directed by physician Principal Display Panel - Carton Label for Physician's Sample"],"precautions":["PRECAUTIONS Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive."],"set_id":"64d403dc-90ca-414d-8ffb-f01a611e66c0","spl_product_data_elements":["Gesticare DHA thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, choline bitartrate, doconexent, and icosapent Gesticare thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, and choline bitartrate THIAMINE MONONITRATE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CYANOCOBALAMIN ASCORBIC ACID ASCORBIC ACID NIACIN NIACIN FOLIC ACID FOLIC ACID FERROUS FUMARATE FERROUS CATION CALCIUM CARBONATE CARBONATE ION CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE .ALPHA.-TOCOPHEROL POTASSIUM IODIDE IODIDE ION ZINC OXIDE ZINC OXIDE CHOLINE BITARTRATE CHOLINE CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE CITRIC ACID MONOHYDRATE TALC MALTODEXTRIN FD&C RED NO. 40 TITANIUM DIOXIDE STEARIC ACID MICROCRYSTALLINE CELLULOSE STARCH, POTATO CALCIUM SULFATE, UNSPECIFIED FORM GELATIN, UNSPECIFIED SUCROSE SOYBEAN OIL ANHYDROUS DIBASIC CALCIUM PHOSPHATE POLYVINYL ALCOHOL, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED FD&C YELLOW NO. 6 FD&C BLUE NO. 1 P-114, light, coated oblong DHA doconexent and icosapent DOCONEXENT DOCONEXENT ICOSAPENT ICOSAPENT GELATIN, UNSPECIFIED GLYCERIN SUNFLOWER OIL ASCORBYL PALMITATE POLYSORBATE 80 TOCOPHEROL Gesticare thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, and choline bitartrate THIAMINE MONONITRATE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CYANOCOBALAMIN ASCORBIC ACID ASCORBIC ACID NIACIN NIACIN FOLIC ACID FOLIC ACID FERROUS FUMARATE FERROUS CATION CALCIUM CARBONATE CARBONATE ION CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE .ALPHA.-TOCOPHEROL POTASSIUM IODIDE IODIDE ION ZINC OXIDE ZINC OXIDE CHOLINE BITARTRATE CHOLINE CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE CITRIC ACID MONOHYDRATE TALC MALTODEXTRIN FD&C RED NO. 40 TITANIUM DIOXIDE STEARIC ACID MICROCRYSTALLINE CELLULOSE STARCH, POTATO CALCIUM SULFATE, UNSPECIFIED FORM GELATIN, UNSPECIFIED SUCROSE SOYBEAN OIL ANHYDROUS DIBASIC CALCIUM PHOSPHATE POLYVINYL ALCOHOL, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED FD&C YELLOW NO. 6 FD&C BLUE NO. 1 P-114, light, coated oblong DHA doconexent and icosapent DOCONEXENT DOCONEXENT ICOSAPENT ICOSAPENT GELATIN, UNSPECIFIED GLYCERIN SUNFLOWER OIL ASCORBYL PALMITATE POLYSORBATE 80 TOCOPHEROL"],"version":"9","warnings":["WARNINGS Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis."]}