{"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-B Tablets are a prescription prenatal dietary supplement tablet that provide B-vitamin supplementation and specifically are formulated with vitamin B6 and Ginger to help calm pregnancy-related nausea and vomiting (ordinary morning sickness), and may be used in conjunction with a physician prescribed prenatal regimen. Prenaissance Next-B Tablets contain 100 mg Ginger Root Extract that, when standardized to Gingerols, is equivalent to 500 mg Ginger Root Powder. Each green tablet is embossed with “364” on one side and is blank on the other. SUPPLEMENT FACTS EACH TABLET CONTAINS: Vitamin B 6 (Pyridoxine Hydrochloride) 42 mg Folic Acid 1.22 mg Calcium (as Calcium Carbonate) 124.23 mg Ginger root extract (Standardized to 5% Gingerols) 100 mg OTHER INGREDIENTS Cellulose, Croscarmellose Sodium, Stearic Acid, Silicon Dioxide, Magnesium Stearate, HPMC, Triacein, Titanium Dioxide, FD&C Yellow #5, FD&C Yellow #6, FD&C Blue #1, FD&C Blue #2."],"description_table":["
SUPPLEMENT FACTS
EACH TABLET CONTAINS:
Vitamin B6 (Pyridoxine Hydrochloride) 42 mg
Folic Acid 1.22 mg
Calcium (as Calcium Carbonate) 124.23 mg
Ginger root extract (Standardized to 5% Gingerols) 100 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One or two tablets daily, in divided doses, or as directed by a physician."],"effective_time":"20180515","how_supplied":["HOW SUPPLIED Bottles of 60 tablets (42192-364-60). 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":"7dd19de4-575b-4791-9b64-ebf83521c3de","indications_and_usage":["INDICATIONS Prenaissance Next-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 - 60 Tablets NDC 42192-364-60 Prenaissance Next-B R x Prenatal Vitamin with B Vitamins and Ginger Dietary Supplement 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":"041d870c-ebea-40c4-9139-61b744623c8a","spl_product_data_elements":["Prenaissance Next-B PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CALCIUM CARBONATE, GINGER PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CALCIUM CARBONATE CALCIUM CATION GINGER GINGER POWDERED CELLULOSE CROSCARMELLOSE SODIUM STEARIC ACID SILICON DIOXIDE MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 FD&C BLUE NO. 1 FD&C BLUE NO. 2 364"],"spl_unclassified_section":["Rx Only"],"storage_and_handling":["STORAGE Store at 15° - 30°C (59° - 86°F) [See USP]. Protect from light and heat. 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 recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein. THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE,TREAT, CURE OR PREVENT ANY DISEASE. MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30022 1-800-541-4802 Rev. 1113"],"version":"1"}