{"adverse_reactions":["ADVERSE REACTIONS Iron: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) can occur but are usually mild and can subside with continuation of therapy. Although the absorption of iron is best when taken between meals, Renate DHA 430 mg, when taken after meals, may control occasional G.I. disturbances. Renate DHA 430 mg is best absorbed when taken at bedtime. Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at: 1-800-FDA-1088."],"contraindications":["CONTRAINDICATIONS Renate DHA 430 mg is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish oil and soy. Iron is contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. This product is contraindicated for persons with pernicious anemia, as folic acid may obscure its signs and symptoms."],"description":["DESCRIPTION Renate DHA 430 mg is a high-potency, multivitamin, multi-mineral nutritional supplement with DHA (Omega-3 Fatty Acid). Other Ingredients (Renate DHA 430 mg caplet): Mono and Diglycerides, Croscarmellose Sodium, Maltodextrin, Hydroxypropyl Methylcellulose, Crospovidone, Stearic Acid, Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, Acacia, Sucrose, Polyethylene Glycol, Starch, Dicalcium Phosphate, Ascorbyl Palmitate, dl-alpha Tocopherol, Sodium Ascorbate, Titanium Dioxide, Carmine Powder, Gelatin, Polysorbate, Riboflavin CFR73.45, Triacetin. Contains Soy. May contain Povidone and Polydextrose. Contains NO artificial flavors or preservatives, yeast, wheat, gluten, nuts or milk-based by-products. Other Ingredients (Renate DHA 430 mg softgel): Gelatin, Water, Glycerin, Polysorbate 80. Also contains Eicosapentaenoic Acid (EPA) and other omega-3 fatty acids (from tuna oil). Contains Soy and Fish Oil (from tuna oil). WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this and all drugs out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Renate DHA Extra 430 mg supplies important prenatal vitamins, minerals and nutrients to supplement the nutritional needs of women, before, during and after pregnancy. Deficiencies of these nutrients are common during pregnancy and lactation, and should be prescribed by a physician prior to conception. Renate DHA 430 mg caplet is manufactured in a drug-certified cGMP (current good manufacturing practices) facility and meets or exceeds USP standards for potency, purity and dissolution. Renate DHA 430 mg softgel complies with the most stringent worldwide standards for fish oil and is manufactured in a NSF Certified cGMP Facility."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Before, during and after pregnancy, adult women (over 12 years of age), take one (1) caplet and one (1) softgel by mouth daily, between meals or as prescribed by a physician. Caplet and softgel may be taken separately. Do not exceed the recommended dosage. Do not administer to children under 12 years of age or persons age 65 or older. Do not exceed one gram (1,000 mg) of DHA per day."],"effective_time":"20091211","how_supplied":["HOW SUPPLIED Renate DHA 430 mg is a 30-day regimen supplied as one bottle containing 30 dark pink Renate DHA 430 mg Prenatal capsule-shaped caplets imprinted “RE 316” and one bottle containing 30 light yellow DHA softgels. NDC: 68032-372-60. Dispense in tight, light-resistant containers as defined in the USP/NF with child resistant closures. Store at controlled room temperature 15°-30°C (59°-86°F). Keep in a cool, dry place. CAUTION: Rx Only RESERVED FOR PROFESSIONAL RECOMMENDATION: Made in the USA exclusively for River’s Edge Pharmaceuticals, LLC, Suwanee, GA, 30024. All rights reserved. Copyright © by River’s Edge Pharmaceuticals."],"id":"e49c577e-3302-4945-ada1-695329f2b905","indications_and_usage":["INDICATIONS AND USAGE Renate DHA 430 mg is a prescription regimen of prenatal multivitamin, 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. Renate DHA 430 mg is also useful in improving the nutritional status prior to conception."],"openfda":{},"overdosage":["OVERDOSE Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting. In severe cases, iron overdose can cause cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities have resulted. Renate DHA 430 mg should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of reach of children. Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen."],"package_label_principal_display_panel":["PACKAGING Sample Packaging: label"],"precautions":["PRECAUTIONS Folic acid in dosages above 400 mcg daily may obscure megaloblastic (pernicious) anemia in that hematological remission can occur while neurological manifestations (Addisonian anemia) remain progressive."],"set_id":"8dce6d49-4af4-4b7f-8b32-fa1c37a19afc","spl_product_data_elements":["Renate Renate DHA Prenatal Multivitamin and Minerals with DHA BETA CAROTENE BETA CAROTENE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL ALPHA-TOCOPHEROL ALPHA-TOCOPHEROL THIAMINE MONONITRATE THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CARBONATE CALCIUM IRON IRON MAGNESIUM OXIDE MAGNESIUM ZINC OXIDE ZINC CUPRIC OXIDE CUPRIC CATION OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS DOCONEXENT DOCONEXENT RE;316"],"use_in_specific_populations":["USE IN SPECIFIC POPULATIONS Renate DHA 430 mg is not advocated for pediatric or geriatric use."],"version":"4","warnings":["WARNING Folic acid alone is improper therapy in the treatment of pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. Ingestion of omega-3 fatty acids (including alpha-linolenic acid [ALA], eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] from fish oils) of more than 3 grams per day may present antithrombotic effects, including increased bleeding time. Omega-3 fatty acids including DHA and EPA should be avoided in patients with inherited or acquired bleeding diatheses. Patients taking anticoagulant drug products should consult with their physician prior to ingesting omega-3 fatty acids."]}