{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"boxed_warning":["WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) 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 bleeding diathesis.","WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately."],"contraindications":["CONTRAINDICATIONS The product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION Prenaissance DHA is a prescription prenatal/ postnatal multivitamin/mineral tablet and a capsule of an essential fatty acid. The prenatal vitamin is oval shaped, green with yellow and beige specks, and debossed with “356” on one side and blank on the other. The essential fatty acid DHA capsule is blank and amber in color. SUPPLEMENT FACTS Serving Size: 1 tablet Amount per Serving % Daily Value % Daily Value (Pregnant & Lactating Women) Vitamin C (ascorbic acid) 120 mg 200% 200% Calcium (calcium citrate) 125 mg 13% 10% Iron (carbonyl iron, ferrous gluconate) 27 mg 150% 150% Vitamin D 3 (cholecalciferol) 400 IU 100% 100% Vitamin E (dl-alpha tocopheryl acetate) 30 IU 100% 100% Folic Acid 1 mg 250% 125% Thiamin (Vitamin B 1 ) 3 mg 200% 176% Riboflavin (Vitamin B 2 ) 3.4 mg 200% 170% Niacinamide (Vitamin B 3 ) 20 mg 100% 100% Vitamin B 6 (pyridoxine hydrochloride) 20 mg 1000% 800% Iodine (potassium iodide) 150 mcg 100% 100% Zinc (zinc oxide) 25 mg 167% 167% Copper (cupric oxide) 2 mg 100% 100% Docusate Sodium 50 mg † † Each DHA gelatin capsule provides: Serving Size: 1 capsule Docosahexaenoic Acid (DHA) 250 mg † † Eicosapentaenoic Acid (EPA) not more than 2.0% † † † Daily Value (DV) not established."],"description_table":["
SUPPLEMENT FACTS
Serving Size: 1 tablet Amount per Serving % Daily Value % Daily Value (Pregnant & Lactating Women)
Vitamin C (ascorbic acid) 120 mg 200% 200%
Calcium (calcium citrate) 125 mg 13% 10%
Iron (carbonyl iron, ferrous gluconate) 27 mg 150% 150%
Vitamin D3 (cholecalciferol) 400 IU 100% 100%
Vitamin E (dl-alpha tocopheryl acetate) 30 IU 100% 100%
Folic Acid 1 mg 250% 125%
Thiamin (Vitamin B1) 3 mg 200% 176%
Riboflavin (Vitamin B2) 3.4 mg 200% 170%
Niacinamide (Vitamin B3) 20 mg 100% 100%
Vitamin B6 (pyridoxine hydrochloride) 20 mg 1000% 800%
Iodine (potassium iodide) 150 mcg 100% 100%
Zinc (zinc oxide) 25 mg 167% 167%
Copper (cupric oxide) 2 mg 100% 100%
Docusate Sodium 50 mg † †
Each DHA gelatin capsule provides:
Serving Size: 1 capsule
Docosahexaenoic Acid (DHA) 250 mg † †
Eicosapentaenoic Acid (EPA) not more than 2.0% † †
† Daily Value (DV) not established.
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One tablet and one gel capsule daily, or as directed by a physician."],"effective_time":"20180515","how_supplied":["HOW SUPPLIED 42192-356-60. Six child - resistant blister packs of 5 tablets and 5 capsules each. The listed product number is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.. Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]"],"id":"4c5abd2e-4ab7-4ab7-83b3-facb7ed4b436","indications_and_usage":["INDICATIONS Prenaissance DHA is indicated to provide vitamin, mineral and omega-3 fatty acid supplementation prior to conception, throughout pregnancy and during the postnatal period for the lactating and non-lactating mother."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 42192-356-60 Prenaissance DHA R x Prenatal Vitamin Tablet and 250 mg DHA Capsule An R x prenatal vitamin and omega-3 (DHA) derived from an all natural plant source. Contains- Six 5-day blister packs R x Only Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL"],"precautions":["PRECAUTIONS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 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."],"set_id":"7080e2bd-2fe8-4434-89a9-3b17ee9bf6b2","spl_product_data_elements":["Prenaissance DHA ascorbic acid, calcium citrate, iron, cholecalciferol, .alpha.-tocopherol acetate, folic acid, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, potassium iodide, zinc oxide, cupric oxide, docusate sodium prenatal vitamin ascorbic acid, calcium citrate, iron, cholecalciferol, .alpha.-tocopherol acetate, folic acid, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, potassium iodide, zinc oxide, cupric oxide, docusate sodium ASCORBIC ACID ASCORBIC ACID CALCIUM CITRATE CALCIUM CATION CALCIUM CITRATE IRON IRON CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE .ALPHA.-TOCOPHEROL FOLIC ACID FOLIC ACID THIAMINE THIAMINE ION RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE POTASSIUM IODIDE IODIDE ION ZINC OXIDE ZINC OXIDE CUPRIC OXIDE CUPRIC CATION DOCUSATE SODIUM DOCUSATE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM STEARIC ACID MAGNESIUM STEARATE SILICON DIOXIDE SHELLAC ALCOHOL 356 DHA DOCONEXENT and ICOSAPENT DOCONEXENT DOCONEXENT ICOSAPENT ICOSAPENT GELATIN, UNSPECIFIED GLYCERIN WATER amber"],"spl_unclassified_section":["Rx Only Dietary Supplement","OTHER INGREDIENTS (tablet) dicalcium phosphate, microcrystalline cellulose, croscarmelose sodium, stearic acid, magnesium stearate, silicon dioxide and pharmaceutical coating (dewaxed bleached shellac, pure ethyl alcohol). OTHER INGREDIENTS (softgel capsule) bovine gelatin, glycerin and purified water.","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 dietary ingredients, other ingredients and 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 1114-04"],"version":"1"}