information Animi-3 with Vitamin D Generic Name: folic acid, cholecalciferol, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent and soy sterol Dosage Form: capsule Side Effects Dosage Professional Interactions Pregnancy More User Reviews Pricing & Coupons Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. Animi-3 with Vitamin D Package Insert Animi-3 with Vitamin D Each Capsule Contains: Folic Acid (Vitamin B9) 1mg Cholecalciferol (Vitamin D3) 1000IU Pyridoxine Hydrochloride (Vitamin B6) 12.5mg Cyanocobalamin (Vitamin B12) 500mcg Omega-3 Acids 500mg -Docosahexaenoic Acid (DHA) 350mg -Eicosapentaenoic Acid (EPA) 35mg Phytosterols (Plant Sterols) 200mg Patent Pending Rx Only Slideshow PCSK9 Inhibitors: A New Class of Cholesterol Busters Description Animi-3 with Vitamin D Capsules are intended for oral administration. Each Capsule Contains: 1mg Vitamin B-9 (Folic Acid USP), 1000IU Vitamin D-3 (Cholecalciferol), 12.5mg Vitamin B-6 (Pyridoxine Hydrochloride, USP), 500mcg vitamin B-12 (Cyanocobalamin, USP), Pharmaceutical Grade omega-3 Fish Oil providing 500mg Omega-3 Acids; including 350mg Docosahexaenoic Acid (DHA) and 35mg Eicosapentaenoic Acid (EPA) and 200mg Plant Sterols (Phytosterols). Also Contains: Bleached Lecithin NF, Ascorbic Acid USP, Mixed Tocopherols NF, Ascorbyl Palmitate NF and a soft shell capsule (which contains; Gelatin USP, Glycerin NF, Titanium Dioxide USP, FD and C Red #40, FD and C Yellow #6 and USP Purified Water). Indication Animi-3 with Vitamin D Capsules are indicated for improving nutritional status in conditions requiring Essential Fatty Acids, Vitamin B12, Vitamin B6, Vitamin D3 and Folic Acid supplementation. This product is contraindicated in patients with a known hyper-sensitivity to any of the ingredients. Warning Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anti-coagulants and in those known to have inherited or acquired bleeding diathesis. Warning 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 1.0mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Pregnancy and Lactation The safety of phytosterols has not been studied in pregnant or breastfeeding women. There is no evidence that dietary intakes of naturally occurring phytosterols, such as those consumed by vegetarian women, adversely affects pregnancy or lactation. Adverse Reactions Allergic sensitization has been reported following oral, enteral and parenteral administration of folic acid. Dosage and Administration Adults One capsule per day or as directed by a physician. How Supplied Animi-3 with Vitamin D supplied as orange opaque oblong capsules. Each capsule in imprinted with Animi-3D in black opacode. Animi-3 with Vitamin D Capsules are available in bottles of 60 capsules (NDC 66213-542-60). Keep out of reach of children. Dispense in a well-closed, tight light-resistant container as defined in the USP using a child-resistant closure. Storage Conditions: Store at 20-25 C (68-77 F). See USP Controlled Room Temperature. Protect from light and moisture. PBM Pharmaceuticals, Inc. Charlottesville, VA 22902 Rev. 0411 2011 All Rights Reserved. NDC 66213-542-60 60 Capsules Animi 3D with Vitamin D Folic Acid (Vitamin B-9) 1 mg Cholecalciferol (Vitamin D-3) 1000 IU Pyridoxine Hydrochloride (Vitamin B-6) 12.5 mg Cyanocobalamin (Vitamin B-12) 500 mcg Omega 3 Acids 500 mg Docosahexaenoic Acid (DHA) 350 mg Eicosapentaenoic Acid (EPA) 35 mg Phytosterols (Plant Sterols) 200 mg Rx Only Animi-3 with Vitamin D folic acid, cholecalciferol, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent capsule Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66213-542 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Folic Acid (Folic Acid) Folic Acid 1 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 1000 [iU] Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 12.5 mg Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 500 ug Omega-3 Fatty Acids (Omega-3 Fatty Acids) Omega-3 Fatty Acids 500 mg Doconexent (Doconexent) Doconexent 250 mg Icosapent (Icosapent) Icosapent 35 mg Soy Sterol (Soy Sterol) Soy Sterol 200 mg Inactive Ingredients Ingredient Name Strength Ascorbic Acid Alpha-Tocopherol Ascorbyl Palmitate Gelatin Glycerin Titanium Dioxide FD&C Red No. 40 Water Lecithin, Soybean FD&C Yellow No. 6 Product Characteristics Color orange Score no score Shape OVAL (Capsule) Size 20mm Flavor Imprint Code Animi;3D Contains Packaging # Item Code Package Description 1 NDC:66213-542-60 60 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2011 Labeler - PBM Pharmaceuticals, Inc (785470050) Establishment Name Address ID/FEI Operations International Vitamin Corporation 964464114 manufacture Revised: 05/2011 PBM Pharmaceuticals, Inc Next Interactions Print this page Add to My Med List More about Animi-3 with Vitamin D (omega-3 polyunsaturated fatty acids) Side Effects During Pregnancy Dosage Information Drug Interactions Pricing & Coupons 0 Reviews Add your own review/rating Drug class: nutraceutical products Consumer resources Professional resources Omega-3-acid Ethyl Esters (AHFS Monograph) Omega-3-Acid Ethyl Esters (FDA) Other brands: Lovaza , Omacor , Epanova , Triklo , ... +3 more Other Formulations Animi-3 Related treatment guides Dietary Supplementation Hypertriglyceridemia FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Nutraceutical products Related Drugs nutraceutical products glucosamine , melatonin , Fish Oil , Coenzyme Q10 , Lovaza Hypertriglyceridemia fenofibrate , Fish Oil , TriCor , Lovaza , Vascepa , Trilipix , fenofibric acid , Nature's Bounty Red Krill Oil , Lofibra , More... Dietary Supplementation biotin , multivitamin , Fish Oil , ascorbic acid , Coenzyme Q10 , Lovaza , CoQ10 , calcium citrate , Zinc , More... Animi-3 with Vitamin D Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! minimize
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