WARNINGS AND PRECAUTIONS SECTION.
Keep out of reach of children.. Dispense in well-closed, tight light-resistant container as defined in the USP using child-resistant closure.
Warning. Ingestion of more than 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.
ADVERSE REACTIONS SECTION.
Adverse Reactions. Allergic sensitization has been reported following oral, enteral and parenteral administration of folic acid.
This product is contraindicated in patients with known hyper-sensitivity to any of the ingredients.
Description. Animi-3(R) 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 soft shell capsule (which contains; Gelatin USP, Glycerin NF, Titanium Dioxide USP, FD and Red 40, FD and Yellow and USP Purified Water).
DOSAGE & ADMINISTRATION SECTION.
Dosage and Administration. Adults One capsule per day or as directed by physician.
HOW SUPPLIED SECTION.
How Supplied. Animi-3(R) supplied as orange opaque oblong capsules. Each capsule in imprinted with Animi-3 in black opacode. Animi-3(R) Capsules are available in bottles of 60 capsules (NDC 66213-543-60).
INDICATIONS & USAGE SECTION.
Indication. Animi-3(R) Capsules are indicated for improving nutritional status in conditions requiring Essential Fatty Acids, Vitamin B12, Vitamin B6, Vitamin D3 and Folic Acid supplementation.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
NDC 66213-543-60 60 Capsules Animi-3(R) Folic Acid (Vitamin B-9) mg Cholecalciferol (Vitamin D-3) 1000 IU Pyridoxine Hydrochloride (Vitamin B-6) 12.5 mg Cyanocobalamin (Vitamin B-12) 500 mcg Omega Acids 500 mg- Docosahexaenoic Acid (DHA) 350 mg- Eicosapentaenoic Acid (EPA) 35 mgPhytosterols (Plant Sterols) 200 mg Rx Only. Image of label.
PEDIATRIC USE SECTION.
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.
SPL PATIENT PACKAGE INSERT SECTION.
Package Insert. Animi-3(R) 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) 200mgU.S. Patent No. 8,075,910; 8,173,160Rx Only.
SPL UNCLASSIFIED SECTION.
PBM Pharmaceuticals, Inc.Charlottesville, VA 22902Rev. 0113(C)2013 All Rights Reserved.
STORAGE AND HANDLING SECTION.
Storage Conditions:. Store at 20-25C (68-77F). See USP Controlled Room Temperature. Protect from light and moisture.