{"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 Prenaissance Next Tablets are a prescription prenatal vitamin that provide B-vitamin supplementation and are formulated with Vitamin B6 and Ginger to help calm pregnancy-related nausea and vomiting (ordinary morning sickness). Prenaissance Next Tablets contain 100 mg ginger root powder extract that, when standardized to gingerols, is equivalent to 500mg ginger root powder. Each round-shaped, beige-colored tablet is embossed with “346” on one side and blank on the other side. SUPPLEMENT FACTS EACH TABLET CONTAINS: Amount % Daily Value Vitamin B 6 (pyridoxine hydrochloride, USP) 40 mg 2000% Folic Acid, USP 1.2 mg 300% Calcium (as dicalcium phosphate and tricalcium phosphate) 124.1 mg 12.4% Ginger (zingiber offinale) root powder extract 100 mg † †Daily value (DV) not established. OTHER INGREDIENTS Microcrystalline Cellulose, Stearic Acid, Crosscarmellose Sodium, Maltodextrin, Sodium Starch Glycolate, Silicon Dioxide, Magnesium Stearate, Hydroxypropyl Methyl Cellulose, and Talc."],"description_table":["
SUPPLEMENT FACTS
EACH TABLET CONTAINS: Amount % Daily Value
Vitamin B6 (pyridoxine hydrochloride, USP) 40 mg 2000%
Folic Acid, USP 1.2 mg 300%
Calcium (as dicalcium phosphate and tricalcium phosphate) 124.1 mg 12.4%
Ginger (zingiber offinale) root powder extract 100 mg †
†Daily value (DV) not established.
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One or two tablets daily, in divided doses, or as directed by a physician."],"effective_time":"20180514","how_supplied":["HOW SUPPLIED Bottles of 60 tablets (42192-346-60). The listed product number is not a National Drug Code. Instead, Acella Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. DO NOT CHEW."],"id":"622cad39-d501-4c4b-8ea5-37432783fa9e","indications_and_usage":["INDICATIONS Prenaissance Next Tablets are indicated to provide B-vitamin supplementation, with ginger to help calm pregnancy related nausea and vomiting (ordinary morning sickness), and may be used in conjunction with a physician prescribed prenatal regimen."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 60 Tablets NDC 42192-346-60 Prenaissance Next R x Only Dietary Supplement with B Vitamins and Ginger R x Only 60 Tablets Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - 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 1.0 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":"74c8ecd7-fe39-4e0b-863b-de335cb6b68f","spl_product_data_elements":["Prenaissance Next PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, TRICALCIUM PHOSPHATE, GINGER PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID TRICALCIUM PHOSPHATE CALCIUM CATION GINGER GINGER MICROCRYSTALLINE CELLULOSE STEARIC ACID CROSCARMELLOSE SODIUM MALTODEXTRIN SODIUM STARCH GLYCOLATE TYPE A POTATO SILICON DIOXIDE MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED TALC 346"],"spl_unclassified_section":["Rx Only Dietary Supplement","All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. . Each person recommending a prescription substitution using this product shall make such recommendation based on her professional opinion and knowledge, upon evaluating the dietary ingredients, other ingredients and information provided herein. MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30022 1-800-541-4802 Rev. 03-14 v2"],"storage_and_handling":["STORAGE Store at 20°- 25°C (68° - 77°F); excursions permitted to 15°- 30°C (59° - 86°F) [See USP, “Controlled Room Temperature”]. Protect from light and heat."],"version":"1"}