{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cyanocobalamin"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY"],"contraindications":["CONTRAINDICATIONS PreQue™ 10 is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION PreQue™ 10 is a patent-pending product, available by prescription only. PreQue™ 10 is designed specifically to meet the extra nutritional demands of a pregnant woman to satisfy the needs of her growing fetus and to help improve the health status of both the mother and her infant. PreQue™ 10 is formulated to reduce oxidative stress, the imbalance between oxygen free radicals and essential antioxidants, helping to maintain homeostasis and strengthen vascular endothelial lining cells. Each slender, oblong, and coated PreQue™ 10 tablet is light violet in color and imprinted with “PreQue” on one side and “10” on the opposite side. PreQue™ 10 is the only prenatal product to incorporate more than 25 mg DHA into the tablet. Each PreQue™ 10 tablet contains the following micronutrients, balancing tablet size with essential ingredients: Vitamin A (beta-carotene) ......................... 1,250 IU Vitamin C (Pharm-C ® *) .............................. 30 mg Vitamin B1 (thiamine mononitrate) ............. 1 mg Vitamin B 2 (riboflavin) ............................... 1.7 mg Vitamin B 12 (cyanocobalamin) .................... 1 mcg Vitamin D 3 (cholecalciferol) ....................... 120 IU Vitamin E (d-alpha tocopheryl succinate) .... 15 IU Folic Acid .................................................. 0.5 mg Elemental Iron (as carbonyl iron) .............................. 15 mg Copper (as cupric oxide) .............................. 1 mg Magnesium (as magnesium oxide) ............. 10 mg Selenium (as sodium selenate) .................. 7.5 mcg Zinc (as zinc oxide) .................................. 12.5 mg CoQ10 (co-enzyme Q-10) .......................... 50 mg Lycopene .................................................... 5 mg life'sDHA™ **(docosahexaenoic acid) ......... 50 mg *Pharm-C ® is a proprietary blend of ascorbic acid, calcium ascorbate, and sodium ascorbate. Pharm-C ® is a registered trademark of Nexgen Pharma, Inc. ** life’sDHA™ is a trademark of Martek Biosciences Corporation. Before, during, and/or after pregnancy, two (2) PreQue™ 10 tablets should be taken daily or as directed by a physician. The total daily dose of PreQue™ 10 may be taken at one time or in divided doses. PreQue™ 10 is designed specifically to meet the extra nutritional demands of a pregnant woman to satisfy the needs of her growing fetus, help improve the health status of both the mother and her infant, and to reduce oxidative stress. Pregnancy is associated with an increased susceptibility to oxidative stress.(1) CoQ10 is an essential component of oxidative phosphorylation at the mitochondrial level, and also functions to stabilize cell membranes, as well as acting as a potent antioxidant, which has been postulated to be a modulator of gene expression and free radical-induced cell damage.(2,3) Data from both clinical and preclinical studies indicate that CoQ10 is safe for use as a dietary supplement, does not interfere with the biosynthesis of endogenous CoQ9/CoQ10, nor does it accumulate into plasma or tissues.(4) Oxidative stress, and CoQ10 deficiency, has been associated with preeclampsia, a serious medical complication that may occur during pregnancy.(3, 5-7) PreQue™ 10 also contains lycopene. Lycopene is a carotenoid present in human serum and skin as well as the liver, adrenal glands, lungs, prostate, and colon. This micronutrient is believed to possess antioxidant and antiproliferative properties.(8, 9) Lycopene deficiency has been associated with preeclampsia and fetal growth restriction.(10) In addition to CoQ10 and lycopene, PreQue™ 10 has other ingredients with antioxidant properties, such as vitamin A, vitamin C, vitamin E and selenium. The antioxidants in PreQue™ 10 help to maintain vascular health. The other micronutrients in PreQue™ 10 provide balanced prenatal nutrition supplementation to help ensure optimal infant and maternal outcomes. Other Ingredients: Microcrystalline cellulose, dibasic calcium phosphate, glucose, algal oil, mannitol, sodium caseinate (milk), soy protein, high oleic sunflower oil, sodium ascorbate, croscarmellose sodium, tomato lipids, alginate, pea starch, docusate sodium, povidone, hypromellose, polysorbate 80, stearic acid, tricalcium phosphate, tetrasodium diphosphate, soy lecithin, mixed natural tocopherols, ascorbyl palmitate, modified food starch, cornstarch, silicon dioxide, magnesium stearate, hydroxypropyl cellulose, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, sodium benzoate, FD&C blue no. 2, FD&C red no. 40, natural flavors, sucrose, corn syrup. PreQue™ 10 does not contain ethanol, caffeine, iodine or gluten. Allergen Information: Contains milk and soy."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Before, during, and/or after pregnancy, two (2) PreQue™ 10 tablets should be taken daily or as directed by a physician. The total daily dose of PreQue™ 10 may be taken at one time or in divided doses."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Controlled Substance Abuse Dependence"],"drug_and_or_laboratory_test_interactions":["Drug/Laboratory Test Interactions"],"drug_interactions":["Interactions Drug Interactions Drug/Laboratory Test Interactions","Drug Interactions"],"effective_time":"20110318","general_precautions":["General"],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED Bottles of 60 tablets for commercial sale (NDC 59702-710-60) with a child resistant closure and in sample displays of 36 tablets in child resistant blisters (NDC 59702-710-36) for patient trial available only through physician offices. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. DISPENSE IN A TIGHT, LIGHT RESISTANT CONTAINER AS DEFINED BY THE USP/NF WITH A CHILD RESISTANT CLOSURE. Store at 20 to 25°C (68 to 77°F). NOTICE: Contact with moisture can discolor or erode the tablet."],"id":"75874823-62c0-4967-8e1c-c9d73255c5c4","indications_and_usage":["INDICATIONS AND USAGE PreQue™ 10 is a patent-pending product, available by prescription only, designed specifically to meet the extra nutritional demands of a pregnant woman to satisfy the needs of her growing fetus and to help improve the health status of both the mother and her infant. PreQue™ 10 is formulated to reduce oxidative stress, the imbalance between oxygen free radicals and essential antioxidants, helping to maintain homeostasis and strengthen vascular endothelial lining cells. PreQue™ 10 replenishes CoQ10, helping to restore CoQ10 (co-enzyme Q-10) levels."],"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 7124 CL"],"pediatric_use":["Pediatric Use"],"precautions":["PRECAUTIONS Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. General Information for Patients Laboratory Tests Interactions Drug Interactions Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use"],"pregnancy":["Pregnancy Teratogenic Effects Nonteratogenic Effects"],"set_id":"75874823-62c0-4967-8e1c-c9d73255c5c4","spl_product_data_elements":["PREQUE 10 OIL AND WATER SOLUBLE VITAMINS AND MINERALS FOLIC ACID FOLIC ACID RIBOFLAVIN RIBOFLAVIN .ALPHA.-TOCOPHEROL SUCCINATE, D- ALPHA-TOCOPHEROL IRON PENTACARBONYL IRON PENTACARBONYL VITAMIN A BETA CAROTENE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL THIAMINE MONONITRATE THIAMINE CYANOCOBALAMIN CO-57 CYANOCOBALAMIN CO-57 MAGNESIUM OXIDE MAGNESIUM OXIDE ZINC OXIDE ZINC OXIDE SODIUM SELENITE SODIUM CATION CUPRIC OXIDE CUPRIC OXIDE UBIDECARENONE UBIDECARENONE DOCOSANOIC ACID DOCONEXENT LYCOPENE LYCOPENE MANNITOL HYDROXYMETHYL CELLULOSE IRON CALCIUM ASCORBATE SODIUM ASCORBATE MAGNESIUM OXIDE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM STEARIC ACID MAGNESIUM STEARATE Light Violet PreQue;10"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS Ingestion of more than 3 grams of omega-3 fatty acids (such asDHA) 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."]}