{"adverse_reactions":["ADVERSE REACTIONS Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. 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."],"description":["DESCRIPTION Complete-RF Prenatal Tablets are oval, dye free, white, film-coated, oil and water soluble multivitamin/multimineral tablets debossed \"T008\" on one side. Each tablet for oral administration contains: Vitamin C (ascorbic acid) 120 mg Vitamin D 3 (cholecalciferol) 400 IU Vitamin E (dl-alpha tocopheryl acetate) 30 IU Vitamin B 1 (thiamine mononitrate) 3 mg Vitamin B 2 (riboflavin) 3.4 mg Niacin (niacinamide) 20 mg Vitamin B 6 (pyridoxine hydrochloride) 20 mg Folic Acid 1 mg Vitamin B 12 (cyanocobalamin) 12 mcg Calcium (calcium carbonate) 200 mg Elemental Iron (carbonyl iron) 90 mg Magnesium (magnesium oxide) 30 mg Zinc (zinc oxide) 25 mg Copper (cupric oxide) 2 mg Docusate Sodium 50 mg Inactive Ingredients Citric Acid, Croscarmellose Sodium, Fumed Silica, Gum Arabic, Magnesium Stearate, Microcrystalline Cellulose, PVP K30, Stearic Acid, TriPotassium Citrate."],"description_table":["
Each tablet for oral administration contains:
Vitamin C (ascorbic acid) 120 mg
Vitamin D3 (cholecalciferol) 400 IU
Vitamin E (dl-alpha tocopheryl acetate) 30 IU
Vitamin B1 (thiamine mononitrate) 3 mg
Vitamin B2 (riboflavin) 3.4 mg
Niacin (niacinamide) 20 mg
Vitamin B6 (pyridoxine hydrochloride) 20 mg
Folic Acid 1 mg
Vitamin B12 (cyanocobalamin) 12 mcg
Calcium (calcium carbonate) 200 mg
Elemental Iron (carbonyl iron) 90 mg
Magnesium (magnesium oxide) 30 mg
Zinc (zinc oxide) 25 mg
Copper (cupric oxide) 2 mg
Docusate Sodium 50 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One tablet daily or as prescribed by a physician."],"effective_time":"20130521","geriatric_use":["Geriatric Use Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over 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 functions, and of concomitant disease or other drug therapy."],"how_supplied":["HOW SUPPLIED Complete-RF Prenatal is supplied in bottles of 90 tablets. NDC 13811-008-90 STORAGE Store at Controlled Room Temperature 25°C (77°F); excursions permitted to 15°-30° C (59°- 86°F). [See USP]. Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436). KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN."],"id":"7e1e3f5e-d7ce-4609-b63c-341463ac801b","indications_and_usage":["INDICATIONS AND USAGE Complete-RF Prenatal is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Complete-RF Prenatal can also be beneficial in improving the nutritional status of women prior to conception."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label R x Only NDC 13811-008-90 90 Tablets Complete-RF Prenatal Prenatal Multivitamin/Multimineral Tablets TRIGEN LABORATORIES PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"precautions":["PRECAUTIONS Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over 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 functions, and of concomitant disease or other drug therapy."],"set_id":"83ee7724-ca55-465d-b561-c466fb3c9fef","spl_product_data_elements":["Complete-RF Prenatal 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, and Docusate Sodium Ascorbic Acid Ascorbic Acid Cholecalciferol Cholecalciferol .Alpha.-Tocopherol Acetate, DL- .ALPHA.-TOCOPHEROL, DL- Thiamine Mononitrate THIAMINE ION THIAMINE Riboflavin Riboflavin Niacinamide Niacinamide Pyridoxine Hydrochloride Pyridoxine Folic Acid Folic Acid Cyanocobalamin Cyanocobalamin Calcium Carbonate Calcium Cation Iron Iron Magnesium Oxide MAGNESIUM CATION Zinc Oxide ZINC CATION Cupric Oxide CUPRIC CATION Docusate Sodium Docusate Citric Acid Monohydrate Croscarmellose Sodium Silicon Dioxide Acacia Magnesium Stearate Cellulose, Microcrystalline Povidone K30 Stearic Acid Potassium Citrate Anhydrous T008"],"spl_unclassified_section":["R x Only","R x Only All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence. Manufactured for: TRIGEN Laboratories, Inc. Sayreville, NJ 08872 www.trigenlab.com MADE IN CANADA Rev. 11/10"],"storage_and_handling":["STORAGE Store at Controlled Room Temperature 25°C (77°F); excursions permitted to 15°-30° C (59°- 86°F). [See USP]. Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436). KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN."],"version":"2","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 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. 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."]}