{"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 Focalgin-B™ Tablets are a prescription prenatal vitamin that provide B-vitamin nutrition and are formulated with vitamin B6 and ginger to help calm nausea and vomiting of pregnancy (NVP). Focalgin-B™ Tablets contain 100 mg ginger root powder extract that, when standardized to ginerols, is equivalent to 500 mg ginger root powder. Each caplet shaped tablet is engraved “M-105” on one side with a pink film coat. Each pink tablet contains: Vitamin B6 (pyridoxine hydrochloride, USP) ......................................... 42 mg Folic Acid, USP ................................................................................... 1.22 mg Calcium (as dicalcium phosphate and tricalcium phosphate)........ 124.23 mg Ginger (zingiber officinale) root powder extract .................................100 mg Other Ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, opadry pink, silicon dioxide, starch."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One or two tablets daily, in divided doses, or as directed by a physician."],"effective_time":"20150713","how_supplied":["HOW SUPPLIED Bottles of 60 tablets (NDC 58657-105-60). KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. DO NOT CHEW."],"id":"803c5939-1c76-49d2-ad56-7ecf35fdd931","indications_and_usage":["INDICATIONS Folcalgin-B™ Tablets are indicated to provide B-vitamin supplementation, with ginger to help calm pregnancy related nausea and vomiting (morning sickness), and may be used in conjunction with a physician prescribed prenatal regimen."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 58657-105-60 FOCALGIN-B TABLETS Rx ONLY 60 TABLETS NDC 58657-105-60 FOCALGIN-B TABLETS Rx ONLY 60 TABLETS"],"precautions":["PRECAUTIONS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Concomitant use of ginger in patients with bleeding disorders, or who are on anti-coagulant or anti-platelet therapy, may increase the risk of bleeding."],"set_id":"45009b14-3128-480c-9169-b6dcba7ed3fb","spl_product_data_elements":["Focalgin B Pyridoxine Hydrochloride, Folic Acid, Calcium, and Ginger PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CALCIUM CALCIUM GINGER GINGER CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE STARCH, CORN HYPROMELLOSES TITANIUM DIOXIDE POLYDEXTROSE TALC MALTODEXTRIN MEDIUM-CHAIN TRIGLYCERIDES FERRIC OXIDE RED M;105 caplet"],"storage_and_handling":["Store at controlled room temperature, 15-30°C (59-86°F). Protect from light and moisture. Dist. by: Method Pharmaceuticals, LLC Arlington, TX 76006 1-877-250-3427 www. methodpharm.com ©2013 Method Pharmaceuticals, LLC All rights reserved. Rev. 9/2013"],"version":"4"}