{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"boxed_warning":["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 This product is contraindicated in patients with known hypersensitivity to any of the ingredients, including fish or fish oil."],"description":["DESCRIPTION Prenaissance Harmony DHA is a gluten free prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acids, supplied as tablets and enteric coated softgel capsules. Each yellow, oval tablet contains: VITAMINS: A (beta carotene).............................................................2850 IU C (ascorbic acid)..............................................................120 mg D (cholecalciferol).............................................................840 IU E (dl-alpha tocopheryl acetate).............................................3 mg B 1 (thiamine mononitrate).................................................1.8 mg B 2 (riboflavin)......................................................................4 mg Niacinamide.......................................................................20 mg B 6 (pyridoxine hydrochloride)............................................50 mg Folic Acid.............................................................................1 mg B 12 (cyanocobalamin)......................................................12 mcg MINERALS: Calcium (calcium carbonate)............................................219 mg Iron (polysaccharide iron complex, 13 mg sodium iron EDTA (Ferrazone ® ),13 mg)....................26 mg Magnesium (magnesium oxide).........................................25 mg Zinc (zinc oxide).................................................................25 mg Copper (cupric acid)............................................................2 mg Iodine.............................................................................220 mcg Each frosted, golden-colored, oval, enteric-coated DHA softgel capsule contains a clear solution of not less than 374 mg purified omega-3 long-chain fatty acids including DHA (docosahexaenoic acid), EPA (eicosapentaenoic acid) and DPA (docasapentaenoic acid) in approximately 656 mg of fish oil. OMEGA-3 FATTY ACIDS: Total omega-3 long-chain fatty acids..........No less than 374 mg As DHA........................................................No less than 262 mg As other omega-3 long-chain fatty acids.......No less than 112 mg OTHER INGREDIENTS (tablet): microcrystalline cellulose, croscarmellose sodium, dicalcium phosphate dehydrate, pregelatinized starch, acacia, xanthan gum, silicon dioxide and magnesium stearate. (Coating) hypromellose, polydextrose, D&C Yellow #10 Aluminum Lake, titanium dioxide, talc, maltodextrin, medium chain triglycerides, FD&C Yellow #6 Aluminum Lake and PEG. OTHER INGREDIENTS (Enteric coated DHA softgel capsule): gelatin, glycerin, purified water, food glaze (shellac), sodium alginate, acetylated monoglyceride, polysorbate 80 and potassium sorbate. INDICATIONS Prenaissance Harmony DHA is a gluten free prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. Prenaissance Harmony DHA is also useful in improving the nutritional status prior to conception. CONTRAINDICATIONS This product is contraindicated in patients with known hypersensitivity to any of the ingredients, including fish or fish oil."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Before, during and after pregnancy, one tablet and one enteric-coated softgel capsule taken by mouth daily, or as directed by a physician. The tablet and entericcoated softgel capsule may be taken together or at different times of the day. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day."],"drug_interactions":["DRUG INTERACTIONS Pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized."],"effective_time":"20180518","how_supplied":["HOW SUPPLIED NDC 42192-348-60. Prenaissance Harmony DHA is supplied in child-resistant blister cards containing 30 doses per carton (1 tablet and 1 enteric-coated DHA softgel capsule equals 1 daily dose). Each unit-of-use dispensing carton contains 5 cards with 6 unit-doses per card which is a 30-day supply. The yellow, oval tablet is imprinted with “348” on one side and is blank on the other. The frosted golden-colored oval enteric-coated DHA softgel capsule is not imprinted. Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.] 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. MANUFACTURED FOR: Acella Pharmaceuticals, LLC •Alpharetta, GA 30009 • 1-800-541-4802"],"id":"115767ff-f545-4dcb-867a-20231bb8d93f","inactive_ingredient":["OTHER INGREDIENTS (tablet): microcrystalline cellulose, croscarmellose sodium, dicalcium phosphate dehydrate, pregelatinized starch, acacia, xanthan gum, silicon dioxide and magnesium stearate. (Coating) hypromellose, polydextrose, D&C Yellow #10 Aluminum Lake, titanium dioxide, talc, maltodextrin, medium chain triglycerides, FD&C Yellow #6 Aluminum Lake and PEG. OTHER INGREDIENTS (Enteric coated DHA softgel capsule): gelatin, glycerin, purified water, food glaze (shellac), sodium alginate, acetylated monoglyceride, polysorbate 80 and potassium sorbate."],"indications_and_usage":["INDICATIONS Prenaissance Harmony DHA is a gluten free prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. Prenaissance Harmony DHA is also useful in improving the nutritional status prior to conception."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 42192-348-60 Prenaissance Harmony DHA Prescription Prenatal Vitamins Features a blend of iron and enteric-coated omega-3 long-chain fatty acids (DHA and EPA). 30 day supply - 30 tablets and 30 softgel capsules 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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress."],"set_id":"fb349223-61cc-4008-a48a-3551a55adc9f","spl_product_data_elements":["Prenaissance Harmony DHA .Beta.-Carotene, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Potassium Iodide, Iron, Magnesium Oxide, Zinc Oxide, Cupric Oxide and Omega-3 Fatty Acids Prenaissance Harmony DHA .Beta.-Carotene, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Potassium Iodide, Iron, Magnesium Oxide, Zinc Oxide, and Cupric Oxide .BETA.-CAROTENE .BETA.-CAROTENE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- THIAMINE MONONITRATE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CARBONATE CALCIUM CATION IRON IRON MAGNESIUM OXIDE MAGNESIUM CATION ZINC OXIDE ZINC CATION CUPRIC OXIDE CUPRIC CATION POTASSIUM IODIDE IODIDE ION MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE STARCH, CORN ACACIA XANTHAN GUM SILICON DIOXIDE MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED POLYDEXTROSE D&C YELLOW NO. 10 TITANIUM DIOXIDE TALC MALTODEXTRIN MEDIUM-CHAIN TRIGLYCERIDES FD&C YELLOW NO. 6 POLYETHYLENE GLYCOL, UNSPECIFIED 348 Prenaissance Harmony DHA Omega-3 Fatty Acids OMEGA-3 FATTY ACIDS OMEGA-3 FATTY ACIDS GELATIN, UNSPECIFIED GLYCERIN WATER SHELLAC SODIUM ALGINATE DIACETYLATED MONOGLYCERIDES POLYSORBATE 80 POTASSIUM SORBATE frosted golden"],"spl_unclassified_section":["Rx Only"],"version":"1","warnings":["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 acquired predisposition to bleeding."]}