Healthcare Professionals
Animi-3® with Vitamin D
Each Capsule contains:
- Folic Acid (Vitamin B9) 1mg
- Cholecalciferol (Vitamin D3) 1000 IU
- 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
U.S. Patent No: 8,075,910
Rx Only
Description
Animi-3® with Vitamin D Capsules are intended for oral administration.
Each Capsule Contains: 1 mg Vitamin B9 (Folic Acid USP), 1000 IU Vitamin D3 (Cholecalciferol), 12.5 mg Vitamin B-6 (Pyridoxine Hydrochloride, USP), 500 mcg Vitamin B-12 (Cyanocobalamin, USP), 200 mg Phytosterols and Pharmaceutical Grade Omega-3 Fish Oil providing 500 mg Omega-3 Acids; including 350 mg Docosahexaenoic Acid (DHA) and 35 mg Eicosapentaenoic Acid (EPA).
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&C Red 40, FD&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 D and Folic Acid supplementation.
Contraindications
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients contained within Animi-3® with Vitamin D.
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 is supplied as Orange opaque oblong Capsules. Each Capsule is imprinted with "Animi-3D" in black opacode. Animi-3® with Vitamin D Capsules are available in bottles of 60 capsules (NDC 66213-0542-60).
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.
Healthcare Professionals:
Call (800) 485-9828 for Animi-3® with Vitamin D samples.
Animi-3®
Each Capsule contains:
- Folic Acid 1 mg
- Vitamin B6 12.5 mg
- Vitamin B12 500 mcg
- Omega-3 Acids 500 mg
- Docosahexaenoic Acid (DHA) 350 mg
- Eicosapentaenoic Acid (EPA) 35 mg
- Phytosterols 200mg
U.S. Patent No: 8,075,910
Rx Only
Description
Animi-3® Capsules are intended for oral administration.
Each Capsule Contains: 1 mg Folic Acid USP, 12.5 mg Vitamin B-6 (Pyridoxine Hydrochloride, USP), 500 mcg Vitamin B-12 (Cyanocobalamin, USP), 200 mg Phytosterols and Pharmaceutical Grade Omega-3 Fish Oil providing 500 mg Omega-3 Acids; including 350 mg Docosahexaenoic Acid (DHA) and 35 mg Eicosapentaenoic Acid (EPA).
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&C Red 40 and USP Purified Water).
Indication
Animi-3® Capsules are indicated for improving nutritional status in conditions requiring essential fatty acids, vitamin B12, B6 and folic acid supplementation.
Contraindications
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients contained within Animi-3.
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® supplied as red opaque oblong Capsules. Each Capsule is imprinted with "Animi-3" in black opacode. Animi-3® Capsules are available in bottles of 60 capsules (NDC 66213-0541-60).
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.