{"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. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately."],"contraindications":["CONTRAINDICATIONS Active OB™ is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"dosage_and_administration":["DIRECTIONS Adults Take one softgel daily with or without food, or as prescribed by a licensed medical practitioner. Children under 12 Consult a doctor. Do not exceed the recommended dose."],"effective_time":"20171026","how_supplied":["HOW SUPPLIED Active OB™ is supplied as purple softgel capsules with imprint \"OB01\" in child-resistant bottles containing 30 softgels. (58809-287-30). Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] KEEP CARTON FOR REFERENCE."],"id":"5c7a04ea-cf2e-0a2e-e053-2a91aa0a6af2","indications_and_usage":["INDICATIONS Active OB™ is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Active OB™ can also be beneficial in improving the nutritional status of women prior to conception. This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 Softgels Bottle Label 58809-287-30 ACTIVE OB ™ Prenatal Vitamin Supplement GMPharmaceuticals, Inc. 30 Softgels Rx Manufactured for: GM Pharmaceuticals, Inc. Arlington, TX 76015 Lactose, Gluten and Sugar Free Contains fish oil, soy, and bovine gelatin. KEEP OUT OF REACH OF CHILDREN Protect from light and moisture. PRINCIPAL DISPLAY PANEL - 30 Softgels Bottle Label"],"precautions":["PRECAUTIONS 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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. 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."],"set_id":"5fd8e625-3dec-4487-bdf2-0e84b6d6593a","spl_product_data_elements":["Active OB ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, ZINC OXIDE, CUPRIC SULFATE, and DOCONEXENT RIBOFLAVIN RIBOFLAVIN PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN IRON PENTACARBONYL FERROUS CATION ZINC OXIDE ZINC OXIDE CUPRIC SULFATE CUPRIC CATION DOCONEXENT DOCONEXENT GELATIN GLYCERIN WATER YELLOW WAX LECITHIN, SOYBEAN TITANIUM DIOXIDE FD&C RED NO. 40 ETHYL VANILLIN FD&C BLUE NO. 1 ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, D- .ALPHA.-TOCOPHEROL, D- THIAMINE MONONITRATE THIAMINE ION THIAMINE OB01"],"spl_unclassified_section":["Supplement Facts Serving Size: 1 Softgel Servings per container: 30 Amount per Serving: % Daily Value % Daily Value for Lactating Women Vitamin C (as Ascorbic Acid) 100 mg 167% 167% Vitamin D3 (as Cholecalciferol) 400 IU 100% 100% Vitamin E (as D-Alpha-Tocopheryl) 30 IU 100% 100% Thiamin (Vitamin B1) 2 mg 133% 118% Riboflavin (Vitamin B2) 4 mg 235% 200% Vitamin B6 (as Pyridoxine HCl) 20 mg 1000% 800% Folic Acid 1 mg 250% 125% Vitamin B12 (as Cyanocobalamin) 30 mcg 500% 375% Iron (as Carbonyl Iron) 20 mg 111% 111% Zinc (as Zinc Oxide) 30 mg 200% 200% Copper (as Cupric Sulfate) 2 mg 100% 100% Docosahexaenoic Acid (DHA) 320 mg Daily Values (DV) not established. Active OB™ contains fish oil, soy, and bovine gelatin. OTHER INGREDIENTS: Gelatin (bovine), Glycerin, Purified Water, Yellow Bees Wax, Soy Lecithin, Natural Orange Flavor, Titanium Dioxide, FD&C Red #40, Ethyl Vanillin, FD&C Blue #1. Professional Labeling","Manufactured for: GM Pharmaceuticals, Inc. Arlington, TX 76015 Made in Canada Active OB (™) should be administered under the supervision of a licensed medical practitioner. Protect from light and moisture. Keep out of reach of children. To report adverse side effects or to obtain product information, contact GM Pharmaceuticals at 1-888-535-0305. Covered by U.S. Patent #8263137 Rev. 09/2013"],"spl_unclassified_section_table":["<table width=\"75%\"> <col width=\"50%\" align=\"left\" valign=\"top\"/> <col width=\"10%\" align=\"left\" valign=\"top\"/> <col width=\"20%\" align=\"center\" valign=\"top\"/> <col width=\"20%\" align=\"center\" valign=\"top\"/> <thead> <tr> <th colspan=\"4\" styleCode=\"Lrule Rrule\">Supplement Facts</th> </tr> <tr styleCode=\"Botrule\"> <th colspan=\"4\" styleCode=\"Lrule Rrule\">Serving Size: 1 Softgel  Servings per container: 30 </th> </tr> <tr> <th styleCode=\"Lrule\">Amount per Serving:</th> <th/> <th>% Daily Value</th> <th styleCode=\"Rrule\">% Daily Value for Lactating Women</th> </tr> </thead> <tbody> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule\">Vitamin C (as Ascorbic Acid)</td> <td>100 mg</td> <td>167%</td> <td styleCode=\"Rrule\">167%</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule\">Vitamin D3 (as Cholecalciferol)</td> <td>400 IU</td> <td>100%</td> <td styleCode=\"Rrule\">100%</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule\">Vitamin E (as D-Alpha-Tocopheryl)</td> <td>30 IU</td> <td>100%</td> <td styleCode=\"Rrule\">100%</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule\">Thiamin (Vitamin B1)</td> <td>2 mg</td> <td>133%</td> <td styleCode=\"Rrule\">118%</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule\">Riboflavin (Vitamin B2)</td> <td>4 mg</td> <td>235%</td> <td styleCode=\"Rrule\">200%</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule\">Vitamin B6 (as Pyridoxine HCl)</td> <td>20 mg</td> <td>1000%</td> <td styleCode=\"Rrule\">800%</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule\">Folic Acid</td> <td>1 mg</td> <td>250%</td> <td styleCode=\"Rrule\">125%</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule\">Vitamin B12 (as Cyanocobalamin)</td> <td>30 mcg</td> <td>500%</td> <td styleCode=\"Rrule\">375%</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule\">Iron (as Carbonyl Iron)</td> <td>20 mg</td> <td>111%</td> <td styleCode=\"Rrule\">111%</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule\">Zinc (as Zinc Oxide)</td> <td>30 mg</td> <td>200%</td> <td styleCode=\"Rrule\">200%</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule\">Copper (as Cupric Sulfate)</td> <td>2 mg</td> <td>100%</td> <td styleCode=\"Rrule\">100%</td> </tr> <tr> <td styleCode=\"Lrule\">Docosahexaenoic Acid (DHA)</td> <td>320 mg</td> <td> <footnote ID=\"foot1\">Daily Values (DV) not established.</footnote> </td> <td styleCode=\"Rrule\"> <footnoteRef IDREF=\"foot1\"/> </td> </tr> </tbody> </table>"],"storage_and_handling":["Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] KEEP CARTON FOR REFERENCE."],"version":"2","warnings":["WARNING Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding."]}