{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Paresthesia and somnolence have been reported with pyridoxine. Mild transient diarrhea, polycythemia vera, itching transitory exanthema and feeling of swelling of entire body have been associated with cobalamins. There are occasional reports of hypersensitivity reactions (rash, pruritis, urticaria) in those receiving parenteral hydroxocobalamin and possibly oral hydroxocobalamin."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY"],"contraindications":["CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Magnesium is contraindicated in those with renal failure, those with high-grade atrioventricular blocks (AV) unless those with high-grade AV blocks have an artificial pacemaker."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each round white coated tablet contains folacin (as folic acid USP) 2.05mg, hydroxocobalamin (B12a) 425mcg, pyridoxine (B6) 25mg, d-alpha tocopheryl succinate (as vitamin E) 100IU, magnesium (as magnesium oxide) 100mg. Folpace® Rx tablets do not contain sugar, lactose or dyes. INGREDIENTS: Magnesium oxide, pyridoxine hydrochloride, d-alpha tocopheryl acid succinate, folic acid, hydroxocobalamin chloride, microcrystalline cellulose, calcium silicate, modified cellulose gum, silicon dioxide, magnesium stearate, polysorbate 80, hypromellose, sodium citrate, polyethylene glycol, titanium dioxide."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual adult dose is one or two tablets daily or as directed by a physician."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Controlled Substance Abuse Dependence"],"drug_interactions":["Interactions Drug Interactions Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the latter drug is antagonized by pyridoxine. However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness.","Drug Interactions Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the latter drug is antagonized by pyridoxine. However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness."],"effective_time":"20110315","general_precautions":["General Folic acid when administered as a single agent in doses above 0.1mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. Pregnant women and nursing mothers should avoid supplemental doses of vitamin E higher than RDA amounts. Patient Information: Folpace® Rx tablets are a medical food, for use only under the direction and supervision of a licensed physician."],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED Folpace® Rx is supplied as a round white coated tablet. Each tablet is debossed with \"AP 18\" on the scored side. Folpace® Rx is supplied in bottles of 90 tablets (NDC 68220-018-90)."],"id":"c17e7e4c-8828-4404-8f6c-5712f6f5ac7d","indications_and_usage":["INDICATIONS AND USAGE Folpace® Rx tablets are indicated for the distinctive nutritional requirements of individuals under a physician's treatment with or at risk for: cardiovascular disease, cerebrovascular disease, peripheral vascular disease, arteriosclerotic vascular disease, dementia and cognitive impairment."],"information_for_patients":["Information for Patients"],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers"],"openfda":{},"overdosage":["OVERDOSAGE"],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL ' 6636 CL"],"pediatric_use":["Pediatric Use The safety and effectiveness of Folpace® Rx in pediatric patients have not been established."],"precautions":["PRECAUTIONS General Folic acid when administered as a single agent in doses above 0.1mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. Pregnant women and nursing mothers should avoid supplemental doses of vitamin E higher than RDA amounts. Patient Information: Folpace® Rx tablets are a medical food, for use only under the direction and supervision of a licensed physician. Information for Patients Laboratory Tests Interactions Drug Interactions Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the latter drug is antagonized by pyridoxine. However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness. Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use The safety and effectiveness of Folpace® Rx in pediatric patients have not been established. Geriatric Use"],"pregnancy":["Pregnancy Teratogenic Effects Nonteratogenic Effects"],"set_id":"c17e7e4c-8828-4404-8f6c-5712f6f5ac7d","spl_product_data_elements":["FOLPACE OIL AND WATER SOLUBLE VITAMINS FOLIC ACID FOLIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE .ALPHA.-TOCOPHEROL SUCCINATE, D- ALPHA-TOCOPHEROL CYANOCOBALAMIN CO-58 CYANOCOBALAMIN MAGNESIUM OXIDE CALCIUM SILICATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE YELLOW-MOTTLED CORE AP;18"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS"]}