{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"contraindications":["CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["Description Vinate ® AZ tablets are light pink, film-coated, oval shaped tablets that are intended for oral administration. Each Tablet Contains: Vitamin A (Beta-Carotene) 3000 I.U. Vitamin C (Ascorbic Acid) 120 mg Vitamin D3 (Cholecalciferol) 400 I.U. Vitamin E (dl-Alpha Tocopheryl Acetate) 30 I.U. Vitamin B1 (Thiamine Hydrochloride) 3 mg Vitamin B2 (Riboflavin) 3.5 mg Niacin (Niacinamide) 20 mg Vitamin B6 (Pyridoxine Hydrochloride) 30 mg Folic Acid 1 mg Vitamin B12 (Cyanocobalamin) 12 mcg Biotin 30 mcg Pantothenic Acid (d-Calcium Pantothenate) 8 mg Calcium (Calcium Carbonate) 150 mg Iron (Ferrous Bis-Glycinate Chelate) 27 mg Magnesium (Magnesium Oxide) 75 mg Zinc (Zinc Oxide) 15 mg Copper (Cupric Oxide) 2.5 mg INACTIVE INGREDIENTS: Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Silicon Dioxide, Magnesium Stearate, Dicalcium Phosphate, Maltodextrin, Cornstarch, Glucose, dl-Alpha Tocopherol, Sodium Ascorbate, Hypromellose, Gum Acacia. Coating: Titanium Dioxide, Polydextrose, Hypromellose, Triacetin, Polyethylene Glycol, FD&C Red No. 40 Aluminum Lake, Contains FD&C Yellow No. 6 as a color additive. FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, Sodium Carboxymethylcellulose, Maltodextrin, Dextrose Monohydrate, Lecithin, Ethyl Cellulose, Hydroxypropyl Cellulose, Purified Water."],"description_table":["<table width=\"60%\"> <col width=\"70%\" align=\"left\" valign=\"bottom\"/> <col width=\"30%\" align=\"right\" valign=\"bottom\"/> <tbody> <tr styleCode=\"Toprule\"> <td>Each Tablet Contains:</td> <td/> </tr> <tr> <td>Vitamin A (Beta-Carotene)</td> <td>3000 I.U.</td> </tr> <tr> <td>Vitamin C (Ascorbic Acid)</td> <td>120 mg</td> </tr> <tr> <td>Vitamin D3 (Cholecalciferol)</td> <td>400 I.U.</td> </tr> <tr> <td>Vitamin E (dl-Alpha Tocopheryl Acetate)</td> <td>30 I.U.</td> </tr> <tr> <td>Vitamin B1 (Thiamine Hydrochloride)</td> <td>3 mg</td> </tr> <tr> <td>Vitamin B2 (Riboflavin)</td> <td>3.5 mg</td> </tr> <tr> <td>Niacin (Niacinamide)</td> <td>20 mg</td> </tr> <tr> <td>Vitamin B6 (Pyridoxine Hydrochloride)</td> <td>30 mg</td> </tr> <tr> <td>Folic Acid</td> <td>1 mg</td> </tr> <tr> <td>Vitamin B12 (Cyanocobalamin)</td> <td>12 mcg</td> </tr> <tr> <td>Biotin</td> <td>30 mcg</td> </tr> <tr> <td>Pantothenic Acid (d-Calcium Pantothenate)</td> <td>8 mg</td> </tr> <tr> <td>Calcium (Calcium Carbonate)</td> <td>150 mg</td> </tr> <tr> <td>Iron (Ferrous Bis-Glycinate Chelate)</td> <td>27 mg</td> </tr> <tr> <td>Magnesium (Magnesium Oxide)</td> <td>75 mg</td> </tr> <tr> <td>Zinc (Zinc Oxide)</td> <td>15 mg</td> </tr> <tr styleCode=\"Botrule\"> <td>Copper (Cupric Oxide)</td> <td>2.5 mg</td> </tr> </tbody> </table>"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One tablet daily or as directed by a physician. For use only under the supervision of a licensed physician."],"effective_time":"20110127","how_supplied":["HOW SUPPLIED Vinate ® AZ Tablets are light pink, film-coated oval-shaped tablets available for oral administration. Each tablet is debossed \"B 466\" on one side and plain on the other side. Available in bottles of 90 tablets. NDC 51991-466-90. Storage Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure, as defined in the USP/NF. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product."],"id":"296890fa-59a8-480d-9da1-c8080ec55b22","indications_and_usage":["INDICATIONS Vinate ® AZ tablets are indicated for providing adequate nutritional support for women before, during and after pregnancy."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 90 Tablets Label Breckenridge Pharmaceutical, Inc. NDC 51991-466-90 Vinate ® AZ Prenatal Vitamin and Mineral Supplement Rx ONLY 90 TABLETS Principal Display Panel - 90 Tablets Label"],"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":"7cbd200d-745e-44b8-9617-09f33ff05467","spl_product_data_elements":["Vinate AZ Beta Carotene, Ascorbic Acid, Cholecalciferol, .ALPHA.-TOCOPHEROL ACETATE, DL-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Pantothenate, Calcium Carbonate, Iron, Magnesium Oxide, Zinc Oxide and Cupric Oxide Beta Carotene Vitamin A Ascorbic Acid Ascorbic Acid Cholecalciferol Cholecalciferol .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL ACETATE, DL- Thiamine Hydrochloride Thiamine Riboflavin Riboflavin Niacinamide Niacin Pyridoxine Hydrochloride Pyridoxine Folic Acid Folic Acid Cyanocobalamin Cyanocobalamin Biotin Biotin Calcium Pantothenate Pantothenic Acid Calcium Carbonate Calcium Iron Iron Magnesium Oxide MAGNESIUM CATION Zinc Oxide Zinc Cupric Oxide Copper Cellulose, Microcrystalline Croscarmellose Sodium Stearic Acid Silicon Dioxide Magnesium Stearate Anhydrous Dibasic Calcium Phosphate Maltodextrin starch, corn Alpha-Tocopherol, dl- Sodium Ascorbate Hypromelloses Acacia Titanium Dioxide Polydextrose Triacetin Polyethylene Glycol FD&C Red no. 40 FD&C Yellow no. 6 FD&C Blue no. 2 Aluminum Oxide Carboxymethylcellulose Sodium Dextrose Monohydrate Hydroxypropyl Cellulose Water B466"],"spl_unclassified_section":["Rx Only","ALLERGEN INFORMATION This product contains soy.","Rx Only Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487 Manufactured by: Nexgen Pharma, Inc. Irvine, CA 92614 7048 Rev 2/07"],"storage_and_handling":["Storage Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure, as defined in the USP/NF. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product."],"version":"3","warnings":["WARNINGS Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this and all medications out of reach of children. In case of an accidental overdose, seek professional assistance, or contact a poison control center immediately."]}